{ "FullStudy":{ "Rank":218034, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513590", "OrgStudyIdInfo":{ "OrgStudyId":"NN5401-3940" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-001712-61", "SecondaryIdType":"EudraCT Number" },{ "SecondaryId":"U1111-1120-5633", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"WHO" } ] }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes", "OfficialTitle":"A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)", "Acronym":"BOOST™" }, "StatusModule":{ "StatusVerifiedDate":"March 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 16, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 19, 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 19, 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 19, 2015", "ResultsFirstSubmitQCDate":"October 19, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"November 20, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 13, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 26, 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 and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Diabetes Mellitus, Type 2" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"394", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"IDegAsp BID", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: insulin degludec/insulin aspart" ] } },{ "ArmGroupLabel":"BIAsp 30 BID", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: insulin degludec/insulin aspart" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"insulin degludec/insulin aspart", "InterventionDescription":"Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BIAsp 30 BID", "IDegAsp BID" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in HbA1c (Glycosylated Haemoglobin)", "PrimaryOutcomeDescription":"Change from baseline in HbA1c after 26 weeks of treatment.", "PrimaryOutcomeTimeFrame":"Week 0, week 26" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in Fasting Plasma Glucose (FPG)", "SecondaryOutcomeDescription":"Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.", "SecondaryOutcomeTimeFrame":"Week 0, week 26" },{ "SecondaryOutcomeMeasure":"Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes", "SecondaryOutcomeDescription":"The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.", "SecondaryOutcomeTimeFrame":"Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product" },{ "SecondaryOutcomeMeasure":"Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes", "SecondaryOutcomeDescription":"The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.", "SecondaryOutcomeTimeFrame":"Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Body Weight", "SecondaryOutcomeDescription":"Change from baseline in body weight after 26 weeks of treatment.", "SecondaryOutcomeTimeFrame":"Week 0, week 26" },{ "SecondaryOutcomeMeasure":"Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks", "SecondaryOutcomeDescription":"Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.", "SecondaryOutcomeTimeFrame":"Week 26" },{ "SecondaryOutcomeMeasure":"Number of Treatment Emergent AEs (Adverse Events)", "SecondaryOutcomeDescription":"A Treatment Emergent Adverse Event (TEAE) was defined as an event that had 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. Severity was assessed by investigator.", "SecondaryOutcomeTimeFrame":"Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nInformed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)\nType 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening\nCurrent treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose\nInsulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days\nInsulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)\nHbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis\nBody mass index (BMI) below or equal to 40.0 kg/m^2\n\nExclusion Criteria:\n\nTreatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening)\nAnticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors\nAnticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits\nCardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty\nAny clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial\nPrevious participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period\nKnown or suspected hypersensitivity to trial products or related products", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "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":"Algiers", "LocationZip":"16000", "LocationCountry":"Algeria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Oran", "LocationZip":"31000", "LocationCountry":"Algeria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Setif", "LocationZip":"19000", "LocationCountry":"Algeria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Haskovo", "LocationZip":"6300", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Lukovit", "LocationZip":"5770", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Plovdiv", "LocationZip":"4002", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Ruse", "LocationZip":"7000", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sofia", "LocationZip":"1233", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sofia", "LocationZip":"1431", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sofia", "LocationZip":"1606", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Karlovac", "LocationZip":"47000", "LocationCountry":"Croatia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Osijek", "LocationZip":"31 000", "LocationCountry":"Croatia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Rijeka", "LocationZip":"51 000", "LocationCountry":"Croatia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Zadar", "LocationZip":"23000", "LocationCountry":"Croatia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Zagreb", "LocationZip":"10000", "LocationCountry":"Croatia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Brno", "LocationZip":"65691", "LocationCountry":"Czechia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Hradec Kralove", "LocationZip":"50005", "LocationCountry":"Czechia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Praha 10", "LocationZip":"100 00", "LocationCountry":"Czechia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Praha", "LocationZip":"128 08", "LocationCountry":"Czechia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bochum", "LocationZip":"44869", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Hohenmölsen", "LocationZip":"06679", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Rehlingen-Siersburg", "LocationZip":"66780", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Saint Ingbert-Oberwürzbach", "LocationZip":"66386", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Völklingen", "LocationZip":"66333", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Wangen", "LocationZip":"88239", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bialystok", "LocationZip":"15-445", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Lublin", "LocationZip":"20-044", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Lublin", "LocationZip":"20-538", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Mazowieckie", "LocationZip":"09-400", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Warszawa", "LocationZip":"02-507", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Oradea", "LocationState":"Bihor", "LocationZip":"410469", "LocationCountry":"Romania" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bucharest", "LocationZip":"020614", "LocationCountry":"Romania" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Buzau", "LocationZip":"120203", "LocationCountry":"Romania" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Galati", "LocationZip":"800578", "LocationCountry":"Romania" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sibiu", "LocationZip":"550176", "LocationCountry":"Romania" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bratislava", "LocationZip":"821 02", "LocationCountry":"Slovakia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kosice", "LocationZip":"040 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Antalya", "LocationZip":"07058", "LocationCountry":"Turkey" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Istanbul", "LocationZip":"34096", "LocationCountry":"Turkey" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Istanbul", "LocationZip":"34890", "LocationCountry":"Turkey" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Istanbul", "LocationCountry":"Turkey" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kocaeli", "LocationZip":"41380", "LocationCountry":"Turkey" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Dnipro", "LocationZip":"49023", "LocationCountry":"Ukraine" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kyiv", "LocationZip":"04114", "LocationCountry":"Ukraine" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Lviv", "LocationZip":"79010", "LocationCountry":"Ukraine" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Poltava", "LocationZip":"36003", "LocationCountry":"Ukraine" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Poltava", "LocationZip":"36011", "LocationCountry":"Ukraine" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Vinnytsia", "LocationZip":"21010", "LocationCountry":"Ukraine" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Zhytomyr", "LocationZip":"10002", "LocationCountry":"Ukraine" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"26435365", "ReferenceType":"result", "ReferenceCitation":"Franek E, Haluzík M, Canecki Varžić S, Sargin M, Macura S, Zacho J, Christiansen JS. Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naïve adults with Type 2 diabetes. Diabet Med. 2016 Apr;33(4):497-505. doi: 10.1111/dme.12982. Epub 2015 Nov 17." },{ "ReferencePMID":"26612062", "ReferenceType":"result", "ReferenceCitation":"Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6." },{ "ReferencePMID":"29451706", "ReferenceType":"result", "ReferenceCitation":"Haluzík M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Subjects continued their metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulphonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, α-glucosidase inhibitors for at least 12 weeks prior to randomisation.", "FlowRecruitmentDetails":"The trial was conducted at 47 sites in 10 countries: Algeria (4), Bulgaria (7), Croatia (5), Czech Republic (4), Germany (5), Poland (5), Romania (5), Slovakia (3), Turkey (2), and Ukraine (7).", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"IDegAsp BID", "FlowGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"BIAsp 30 BID", "FlowGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"197" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"197" } ] } },{ "FlowMilestoneType":"Exposed", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"One (1) subject was withdrawn prior to exposure due to “non fulfilment of inclusion criteria”", "FlowAchievementNumSubjects":"196" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Two (2) subjects were withdrawn prior to exposure due to \"withdrawal of consent\"", "FlowAchievementNumSubjects":"195" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"187" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"184" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"10" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"13" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Withdrawal Criteria", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Unclassified", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"10" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"IDegAsp BID", "BaselineGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"BIAsp 30 BID", "BaselineGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"197" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"197" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"394" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureDescription":"Subjects aged ≥18 years were enrolled in this study.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59.0", "BaselineMeasurementSpread":"9.5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"58.8", "BaselineMeasurementSpread":"8.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"58.9", "BaselineMeasurementSpread":"8.9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureDescription":"Male and female aged ≥18 years were enrolled in this study.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"95" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"96" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"191" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"102" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"101" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"203" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Glycosylated Haemoglobin (HbA1c)", "BaselineMeasureDescription":"Glycosylated haemoglobin (HbA1c) was measured at baseline.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Percent (%) glycosylated haemoglobin", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8.5", "BaselineMeasurementSpread":"0.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8.3", "BaselineMeasurementSpread":"0.7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8.4", "BaselineMeasurementSpread":"0.8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Fasting plasma glucose (FPG)", "BaselineMeasureDescription":"Fasting plasma glucose (FPG) was measured at baseline.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mmol/L", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10.5", "BaselineMeasurementSpread":"2.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10.0", "BaselineMeasurementSpread":"2.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"10.2", "BaselineMeasurementSpread":"2.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Weight", "BaselineMeasureDescription":"Body weight was measured at baseline.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"88.0", "BaselineMeasurementSpread":"15.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"88.5", "BaselineMeasurementSpread":"14.9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"88.2", "BaselineMeasurementSpread":"14.9" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in HbA1c (Glycosylated Haemoglobin)", "OutcomeMeasureDescription":"Change from baseline in HbA1c after 26 weeks of treatment.", "OutcomeMeasurePopulationDescription":"The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percent (%) glycosylated haemoglobin", "OutcomeMeasureTimeFrame":"Week 0, week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"197" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"197" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.85", "OutcomeMeasurementSpread":"0.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.73", "OutcomeMeasurementSpread":"0.93" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Fasting Plasma Glucose (FPG)", "OutcomeMeasureDescription":"Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.", "OutcomeMeasurePopulationDescription":"The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. At baseline 195 subjects each in IDegAsp BID and BIAsp 30 BID treatment group were analysed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Week 0, week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"195" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"195" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-4.44", "OutcomeMeasurementSpread":"2.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-3.03", "OutcomeMeasurementSpread":"2.90" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes", "OutcomeMeasureDescription":"The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.", "OutcomeMeasurePopulationDescription":"The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"episodes", "OutcomeMeasureTimeFrame":"Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"196" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"195" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"260" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes", "OutcomeMeasureDescription":"The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.", "OutcomeMeasurePopulationDescription":"The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"episodes", "OutcomeMeasureTimeFrame":"Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"196" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"195" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"553" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1221" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Body Weight", "OutcomeMeasureDescription":"Change from baseline in body weight after 26 weeks of treatment.", "OutcomeMeasurePopulationDescription":"The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data were imputed using last observation carried forward (LOCF).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"kg", "OutcomeMeasureTimeFrame":"Week 0, week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"196" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"195" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.8", "OutcomeMeasurementSpread":"4.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementSpread":"4.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks", "OutcomeMeasureDescription":"Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.", "OutcomeMeasurePopulationDescription":"The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Data for 15 subjects were excluded, as only subjects exposed for at least 12 weeks were included in this measurement.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Week 26", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"192" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"187" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Treatment Emergent AEs (Adverse Events)", "OutcomeMeasureDescription":"A Treatment Emergent Adverse Event (TEAE) was defined as an event that had 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. Severity was assessed by investigator.", "OutcomeMeasurePopulationDescription":"The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"events", "OutcomeMeasureTimeFrame":"Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"IDegAsp BID", "OutcomeGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BIAsp 30 BID", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"196" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"195" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"197" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"137" } ] } } ] } },{ "OutcomeClassTitle":"Serious", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12" } ] } } ] } },{ "OutcomeClassTitle":"Severe", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" } ] } } ] } },{ "OutcomeClassTitle":"Moderate", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"45" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27" } ] } } ] } },{ "OutcomeClassTitle":"Mild", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"139" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"102" } ] } } ] } },{ "OutcomeClassTitle":"Fatal", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"From the first trial-related activity after the subject had signed the informed consent (Week -1) and until post-treatment follow-up period (Week 27).", "EventsDescription":"The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"IDegAsp BID", "EventGroupDescription":"Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.", "EventGroupSeriousNumAffected":"13", "EventGroupSeriousNumAtRisk":"196", "EventGroupOtherNumAffected":"15", "EventGroupOtherNumAtRisk":"196" },{ "EventGroupId":"EG001", "EventGroupTitle":"BIAsp 30 BID", "EventGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.", "EventGroupSeriousNumAffected":"10", "EventGroupSeriousNumAtRisk":"195", "EventGroupOtherNumAffected":"7", "EventGroupOtherNumAtRisk":"195" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Acute coronary syndrome", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Acute myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Angina unstable", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Cardiac failure", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Coronary artery insufficiency", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Myocardial ischaemia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Deafness neurosensory", "SeriousEventOrganSystem":"Ear and labyrinth disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Optic ischaemic neuropathy", "SeriousEventOrganSystem":"Eye disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Colonic stenosis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Diarrhoea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Flatulence", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Inguinal hernia, obstructive", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Non-cardiac chest pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Cholelithiasis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Meningitis pneumococcal", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Peritonsillar abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Pneumonia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Foot fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Hypoglycaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"196" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" } ] } },{ "SeriousEventTerm":"Arthritis", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", 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