{ "FullStudy":{ "Rank":218043, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513473", "OrgStudyIdInfo":{ "OrgStudyId":"NN1250-3561" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-003148-39", "SecondaryIdType":"EudraCT Number" },{ "SecondaryId":"P/44/2010", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"EMA (PDCO)" },{ "SecondaryId":"U1111-1122-4758", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"WHO" } ] }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus", "OfficialTitle":"A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)", "Acronym":"BEGIN™" }, "StatusModule":{ "StatusVerifiedDate":"June 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 16, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 30, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 30, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 12, 2015", "ResultsFirstSubmitQCDate":"December 8, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 12, 2016", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"November 7, 2013", "DispFirstSubmitQCDate":"November 7, 2013", "DispFirstPostDateStruct":{ "DispFirstPostDate":"December 2, 2013", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 3, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 13, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novo Nordisk A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This trial is conducted in Africa, Asia, Europe and the United States of America (USA).\n\nThe aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Diabetes Mellitus, Type 1" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"350", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Insulin Degludec + Insulin Aspart", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: insulin degludec", "Drug: insulin aspart" ] } },{ "ArmGroupLabel":"Insulin Detemir +Insulin Aspart", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: insulin detemir", "Drug: insulin aspart" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"insulin degludec", "InterventionDescription":"Injected subcutaneously (under the skin) once daily. Dose individually adjusted.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin Degludec + Insulin Aspart" ] } },{ "InterventionType":"Drug", "InterventionName":"insulin detemir", "InterventionDescription":"Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin Detemir +Insulin Aspart" ] } },{ "InterventionType":"Drug", "InterventionName":"insulin aspart", "InterventionDescription":"Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin Degludec + Insulin Aspart", "Insulin Detemir +Insulin Aspart" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)", "PrimaryOutcomeDescription":"Change from baseline in HbA1c (%) after 26 weeks of treatment.", "PrimaryOutcomeTimeFrame":"Week 0, week 26" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)", "SecondaryOutcomeDescription":"Change from baseline in HbA1c (%) after 52 weeks of treatments.", "SecondaryOutcomeTimeFrame":"Week 0, week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)", "SecondaryOutcomeDescription":"Change from baseline in FPG after 26 weeks of treatment.", "SecondaryOutcomeTimeFrame":"Week 0, week 26" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)", "SecondaryOutcomeDescription":"Change from baseline in FPG after 52 weeks of treatment.", "SecondaryOutcomeTimeFrame":"Week 0, week 52" },{ "SecondaryOutcomeMeasure":"Number of Treatment Emergent Adverse Events (TEAEs)", "SecondaryOutcomeDescription":"TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.", "SecondaryOutcomeTimeFrame":"After 26 weeks and 52 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Number of Hypoglycaemic Episodes", "SecondaryOutcomeDescription":"Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)", "SecondaryOutcomeTimeFrame":"After 26 weeks and 52 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))", "SecondaryOutcomeDescription":"Episodes of PG >11.1mmol/L (200mg/dL)", "SecondaryOutcomeTimeFrame":"After 26 weeks and 52 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))", "SecondaryOutcomeDescription":"Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment", "SecondaryOutcomeTimeFrame":"After 26 weeks and 52 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment", "SecondaryOutcomeDescription":"Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.", "SecondaryOutcomeTimeFrame":"Between week 1 and week 26" },{ "SecondaryOutcomeMeasure":"Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)", "SecondaryOutcomeDescription":"Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)", "SecondaryOutcomeTimeFrame":"After 52 weeks of treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nInformed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements\nMale or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)\nOngoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed\nHbA1c (glycosylated haemoglobin) maximum 11%\n\nExclusion Criteria:\n\nKnown or suspected hypersensitivity to trial product(s) or related products\nPrevious participation in this trial. Participation is defined as randomisation\nGirls who are pregnant, breastfeeding or intend to become pregnant\nGirls who have had menarche and are not using adequate contraceptive measures according to local requirements\nKnown hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)\nMore than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1\nSignificant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial\nThe receipt of any investigational drug within 1 month prior to Visit 1", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"1 Year", "MaximumAge":"17 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Global Clinical Registry (GCR, 1452)", "OverallOfficialAffiliation":"Novo Nordisk A/S", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Little Rock", "LocationState":"Arkansas", "LocationZip":"72202", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Orange", "LocationState":"California", "LocationZip":"92868", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"San Diego", "LocationState":"California", "LocationZip":"92123", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Aurora", "LocationState":"Colorado", "LocationZip":"80045", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06511", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Gainesville", "LocationState":"Florida", "LocationZip":"32608", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Jacksonville", "LocationState":"Florida", "LocationZip":"32207", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Maitland", "LocationState":"Florida", "LocationZip":"32751", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Melbourne", "LocationState":"Florida", "LocationZip":"32901", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Tallahassee", "LocationState":"Florida", "LocationZip":"32308", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Atlanta", "LocationState":"Georgia", "LocationZip":"30322", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Atlanta", "LocationState":"Georgia", "LocationZip":"30339", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40503", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Louisville", "LocationState":"Kentucky", "LocationZip":"40202", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21201", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21229", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02215", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Worcester", "LocationState":"Massachusetts", "LocationZip":"01655", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Buffalo", "LocationState":"New York", "LocationZip":"14203", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Akron", "LocationState":"Ohio", "LocationZip":"44308", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationZip":"45229", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Hershey", "LocationState":"Pennsylvania", "LocationZip":"17033", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19104", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Pittsburgh", "LocationState":"Pennsylvania", "LocationZip":"15224", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75235", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"San Antonio", "LocationState":"Texas", "LocationZip":"78207", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Norfolk", "LocationState":"Virginia", "LocationZip":"23507", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Richmond", "LocationState":"Virginia", "LocationZip":"23235", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sofia", "LocationZip":"1606", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Varna", "LocationZip":"9010", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Espoo", "LocationZip":"02740", "LocationCountry":"Finland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kuopio", "LocationZip":"70210", "LocationCountry":"Finland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Mikkeli", "LocationZip":"50100", "LocationCountry":"Finland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"OYS", "LocationZip":"90029", "LocationCountry":"Finland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Pori", "LocationZip":"28500", "LocationCountry":"Finland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"BRON cedex", "LocationZip":"69677", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Paris", "LocationZip":"75015", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Rennes", "LocationZip":"35056", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Toulouse", "LocationZip":"31059", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Berlin", "LocationZip":"13353", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Hannover", "LocationZip":"30173", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Ludwigshafen", "LocationZip":"67059", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Münster", "LocationZip":"48155", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Chieti", "LocationZip":"66100", "LocationCountry":"Italy" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Genova", "LocationZip":"16147", "LocationCountry":"Italy" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Roma", "LocationZip":"00165", "LocationCountry":"Italy" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Chuo-shi, Yamanashi", "LocationZip":"409 3898", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Fukushima", "LocationZip":"963-8851", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Iruma-gun, Saitama", "LocationZip":"350 0495", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kobe-shi, Hyogo", "LocationZip":"657-0846", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kochi-shi, Kochi", "LocationZip":"780 0952", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kumamoto-shi, Kumamoto", "LocationZip":"860 8556", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Maebashi-shi, Gunma", "LocationZip":"371-8511", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Musashino-shi, Tokyo", "LocationZip":"180 0023", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Niigata-shi, Niigata", "LocationZip":"951 8520", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Osaka-shi, Osaka", "LocationZip":"545 8586", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sendai-shi, Miyagi", "LocationZip":"980 8574", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Tokyo", "LocationZip":"157 8535", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Tokyo", "LocationZip":"162 8666", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Toyonaka-city, Osaka", "LocationZip":"560 0004", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Tsu-shi, Mie", "LocationZip":"514 0125", "LocationCountry":"Japan" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Almere", "LocationZip":"1315 RA", "LocationCountry":"Netherlands" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Amersfoort", "LocationZip":"3816 CP", "LocationCountry":"Netherlands" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Eindhoven", "LocationZip":"5623 EJ", "LocationCountry":"Netherlands" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Nijmegen", "LocationZip":"6532 CL", "LocationCountry":"Netherlands" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Rotterdam", "LocationZip":"3011 TA", "LocationCountry":"Netherlands" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Skopje", "LocationZip":"1000", "LocationCountry":"North Macedonia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Moscow", "LocationZip":"117036", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Moscow", "LocationZip":"119049", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Moscow", "LocationZip":"125373", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Novosibirsk", "LocationZip":"630048", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Saint-Petersburg", "LocationZip":"191144", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Saratov", "LocationZip":"410028", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Saratov", "LocationZip":"410054", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Johannesburg", "LocationState":"Gauteng", "LocationZip":"2193", "LocationCountry":"South Africa" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Cape Town", "LocationState":"Western Cape", "LocationZip":"7925", "LocationCountry":"South Africa" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Aberdeen", "LocationZip":"AB25 2ZG", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Birmingham", "LocationZip":"B4 6NH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Manchester", "LocationZip":"M13 9WL", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Norwich", "LocationZip":"NR4 7UY", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sheffield", "LocationZip":"S102TH", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30666772", "ReferenceType":"background", "ReferenceCitation":"Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10." },{ "ReferencePMID":"25683037", "ReferenceType":"result", "ReferenceCitation":"Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"The trial was conducted at 72 sites in 12 countries as follows:\n\nBulgaria (2), Finland (5), France (4), Germany (3), Italy (2), Japan (15), Netherlands (5), Republic of Macedonia (2), Russian Federation (6), South Africa (2), United Kingdom (4), United States (22)", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"IDeg + IAsp", "FlowGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"IDet + IAsp", "FlowGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Main Trial (26 Weeks)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"174" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"1 subject was randomised but withdrew before the drug exposure.", "FlowAchievementNumSubjects":"176" } ] } },{ "FlowMilestoneType":"Exposed", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"174" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"175" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"170" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"165" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"11" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"7" } ] } },{ "FlowDropWithdrawType":"Unclassified", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } } ] } },{ "FlowPeriodTitle":"Extension Trial (26 Weeks)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"18 subjects did not consent to participate in the extension trial.", "FlowAchievementNumSubjects":"152" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"37 subjects did not consent to participate in the extension trial.", "FlowAchievementNumSubjects":"128" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"151" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"122" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Full Analysis set (FAS) included all randomised subjects.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"IDeg + IAsp", "BaselineGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"IDet + IAsp", "BaselineGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"174" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"176" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"350" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"174" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"176" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"350" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"78" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"78" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"156" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"96" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"98" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"194" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)", "OutcomeMeasureDescription":"Change from baseline in HbA1c (%) after 26 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"percentage of glycosylated haemoglobin", "OutcomeMeasureTimeFrame":"Week 0, week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"176" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.20", "OutcomeMeasurementSpread":"0.95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.31", "OutcomeMeasurementSpread":"0.89" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)", "OutcomeMeasureDescription":"Change from baseline in HbA1c (%) after 52 weeks of treatments.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"percentage of glycosylated haemoglobin", "OutcomeMeasureTimeFrame":"Week 0, week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"176" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.27", "OutcomeMeasurementSpread":"1.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.22", "OutcomeMeasurementSpread":"1.03" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)", "OutcomeMeasureDescription":"Change from baseline in FPG after 26 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Week 0, week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"160" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.67", "OutcomeMeasurementSpread":"5.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.50", "OutcomeMeasurementSpread":"8.37" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)", "OutcomeMeasureDescription":"Change from baseline in FPG after 52 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Week 0, week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"160" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.29", "OutcomeMeasurementSpread":"6.53" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.10", "OutcomeMeasurementSpread":"8.24" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Treatment Emergent Adverse Events (TEAEs)", "OutcomeMeasureDescription":"TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all subjects receiving at least one dose of investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"events", "OutcomeMeasureTimeFrame":"After 26 weeks and 52 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"TEAEs -26 weeks", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"810" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"761" } ] } } ] } },{ "OutcomeClassTitle":"TEAEs -52 weeks", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1462" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1266" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Hypoglycaemic Episodes", "OutcomeMeasureDescription":"Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)", "OutcomeMeasurePopulationDescription":"Safety analysis set included all subjects receiving at least one dose of investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"episodes", "OutcomeMeasureTimeFrame":"After 26 weeks and 52 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"26 weeks (entire day)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11712" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10991" } ] } } ] } },{ "OutcomeClassTitle":"26 weeks (nocturnal)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1261" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1458" } ] } } ] } },{ "OutcomeClassTitle":"52 weeks (entire day)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21560" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"18373" } ] } } ] } },{ "OutcomeClassTitle":"52 weeks (nocturnal)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2336" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2586" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))", "OutcomeMeasureDescription":"Episodes of PG >11.1mmol/L (200mg/dL)", "OutcomeMeasurePopulationDescription":"Safety analysis set included all subjects receiving at least one dose of investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"episodes", "OutcomeMeasureTimeFrame":"After 26 weeks and 52 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"26 weeks", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31264" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"31173" } ] } } ] } },{ "OutcomeClassTitle":"52 weeks", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"58679" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"52831" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))", "OutcomeMeasureDescription":"Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"episodes", "OutcomeMeasureTimeFrame":"After 26 weeks and 52 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"26 weeks", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"86" } ] } } ] } },{ "OutcomeClassTitle":"52 weeks", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"109" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"161" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment", "OutcomeMeasureDescription":"Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"pmol/L", "OutcomeMeasureTimeFrame":"Between week 1 and week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"week 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4540.4", "OutcomeMeasurementSpread":"3999.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3972.2", "OutcomeMeasurementSpread":"6721.8" } ] } } ] } },{ "OutcomeClassTitle":"week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4148.1", "OutcomeMeasurementSpread":"3726.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5430.1", "OutcomeMeasurementSpread":"9067.7" } ] } } ] } },{ "OutcomeClassTitle":"week 26", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4105.6", "OutcomeMeasurementSpread":"3456.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6377.0", "OutcomeMeasurementSpread":"10930.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)", "OutcomeMeasureDescription":"Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"%B/T", "OutcomeMeasureTimeFrame":"After 52 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDeg + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"IDet + IAsp", "OutcomeGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"174" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Insulin aspart specific antibodies", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.1", "OutcomeMeasurementSpread":"2.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.5", "OutcomeMeasurementSpread":"2.3" } ] } } ] } },{ "OutcomeClassTitle":"Insulin Detemir specific antibodies", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The antibody analysis was for subjects taking insulin detemir only" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.1", "OutcomeMeasurementSpread":"6.5" } ] } } ] } },{ "OutcomeClassTitle":"Insulin Degludec specific antibodies", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The antibody analysis was for subjects taking insulin degludec only" } ] } } ] } },{ "OutcomeClassTitle":"X-reacting AB Hu Insulin", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17.2", "OutcomeMeasurementSpread":"7.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"26.0", "OutcomeMeasurementSpread":"19.3" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)", "EventsDescription":"Safety analysis set included all subjects receiving at least one dose of investigational product.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"IDeg + IAsp", "EventGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.", "EventGroupSeriousNumAffected":"18", "EventGroupSeriousNumAtRisk":"174", "EventGroupOtherNumAffected":"146", "EventGroupOtherNumAtRisk":"174" },{ "EventGroupId":"EG001", "EventGroupTitle":"IDet + IAsp", "EventGroupDescription":"Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.", "EventGroupSeriousNumAffected":"16", "EventGroupSeriousNumAtRisk":"175", "EventGroupOtherNumAffected":"143", "EventGroupOtherNumAtRisk":"175" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Faecaloma", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Vomiting", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Appendicitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Bronchitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Gastroenteritis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Gastroenteritis viral", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Pharyngitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Respiratory tract infection viral", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Urinary tract infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Accidental overdose", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Toxicity to various agents", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Wrong drug administered", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Blood ketone body increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Body temperature increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Dehydration", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Diabetic ketoacidosis", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Hypoglycaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Ketosis", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Convulsion", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Headache", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Hypoglycaemic seizure", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Hypoglycaemic unconsciousness", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Loss of consciousness", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Anxiety disorder", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } },{ "SeriousEventTerm":"Cough", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"174" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"175" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Ear pain", "OtherEventOrganSystem":"Ear and labyrinth disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"12", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"174" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"175" } ] } },{ "OtherEventTerm":"Abdominal pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"16", "OtherEventStatsNumAffected":"12", "OtherEventStatsNumAtRisk":"174" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"12", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"175" } ] } },{ "OtherEventTerm":"Abdominal pain upper", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"42", "OtherEventStatsNumAffected":"28", "OtherEventStatsNumAtRisk":"174" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"30", "OtherEventStatsNumAffected":"17", "OtherEventStatsNumAtRisk":"175" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"26", "OtherEventStatsNumAffected":"22", "OtherEventStatsNumAtRisk":"174" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"25", "OtherEventStatsNumAffected":"17", "OtherEventStatsNumAtRisk":"175" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"18", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"174" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"12", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"175" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", 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