{ "FullStudy":{ "Rank":218220, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511172", "OrgStudyIdInfo":{ "OrgStudyId":"NN2211-1499" }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes", "OfficialTitle":"Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2002" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2002", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2002", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novo Nordisk A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Diabetes Mellitus, Type 2" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"145", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"NNC 90-1170 + Met", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: metformin" ] } },{ "ArmGroupLabel":"NNC 90-1170 + Met placebo", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: placebo" ] } },{ "ArmGroupLabel":"Met + NNC 90-1170 placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: metformin", "Drug: placebo" ] } },{ "ArmGroupLabel":"Met + Glim", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: metformin", "Drug: glimepiride" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170 + Met" ] } },{ "InterventionType":"Drug", "InterventionName":"metformin", "InterventionDescription":"1000 mg daily, administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Met + Glim", "Met + NNC 90-1170 placebo", "NNC 90-1170 + Met" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"Metformin placebo administered orally. 1000 mg daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170 + Met placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Met + NNC 90-1170 placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"glimepiride", "InterventionDescription":"Individually adjusted dose, administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Met + Glim" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Fasting plasma/serum glucose" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Home monitored fasting plasma glucose" },{ "SecondaryOutcomeMeasure":"Home monitored 7-point glucose profile" },{ "SecondaryOutcomeMeasure":"Fructosamine" },{ "SecondaryOutcomeMeasure":"Insulin" },{ "SecondaryOutcomeMeasure":"C-peptide" },{ "SecondaryOutcomeMeasure":"HbA1c (glycated haemoglobin A1c)" },{ "SecondaryOutcomeMeasure":"Weight" },{ "SecondaryOutcomeMeasure":"Beta-cell function and insulin resistance (HOMA model)" },{ "SecondaryOutcomeMeasure":"Gastro-intestinal adverse events" },{ "SecondaryOutcomeMeasure":"Other adverse events" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months\nDuration of type 2 diabetes diagnosis at least one year\nHbA1c 8.0-13.0%, both inclusive\nBody Mass Index (BMI) between 25-40 kg/m^2, both inclusive.\n\nExclusion Criteria:\n\nCurrent treatment with thiazolidinediones or insulin initiated within the last four months prior to trial\nImpaired liver function\nImpaired renal function\nCardiac problems\nUncontrolled treated/untreated hypertension\nCancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial\nRecurrent major hypoglycaemia as judged by the Investigator\nKnown or suspected allergy to trial product or related products\nUse of any drug (except for OHAs), which in the Investigator's opinion could interfere with the glucose level\nKnown or suspected abuse of alcohol or narcotics\nAny contraindications to metformin or glimepiride according to the local guidelines", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 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":"Daw Park", "LocationState":"South Australia", "LocationZip":"5041", "LocationCountry":"Australia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Adelaide", "LocationZip":"SA 5035", "LocationCountry":"Australia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Ashford", "LocationZip":"5035", "LocationCountry":"Australia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Garran", "LocationZip":"2605", "LocationCountry":"Australia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Wien", "LocationZip":"1030", "LocationCountry":"Austria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Wien", "LocationZip":"A 1090", "LocationCountry":"Austria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Wien", "LocationZip":"A-1130", "LocationCountry":"Austria" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Ceske Budejovice", "LocationZip":"37001", "LocationCountry":"Czech Republic" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Praha 10", "LocationZip":"10034", "LocationCountry":"Czech Republic" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Frederiksberg", "LocationZip":"2000", "LocationCountry":"Denmark" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"København", "LocationZip":"2400", "LocationCountry":"Denmark" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Køge", "LocationZip":"4600", "LocationCountry":"Denmark" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Thisted", "LocationZip":"7700", "LocationCountry":"Denmark" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Århus C", "LocationZip":"8000", "LocationCountry":"Denmark" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"LA ROCHELLE cedex", "LocationZip":"17019", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Narbonne", "LocationZip":"11108", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"NEVERS cedex", "LocationZip":"58033", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Paris Cedex 10", "LocationZip":"75475", "LocationCountry":"France" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bad Lauterberg", "LocationZip":"37431", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Berlin", "LocationZip":"12203", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bochum", "LocationZip":"44791", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Freiburg", "LocationZip":"79106", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Kaiserslautern", "LocationZip":"67675", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Mannheim", "LocationZip":"68167", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Neuss", "LocationZip":"41460", "LocationCountry":"Germany" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Rawa Mazowiecka", "LocationZip":"96-200", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Zabrze", "LocationZip":"41-800", "LocationCountry":"Poland" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Addlestone", "LocationZip":"KT15 2BH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Aylesbury", "LocationZip":"HP21 7TL", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Barnsley", "LocationZip":"S70 3RJ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Bexhill-on-Sea", "LocationZip":"TN39 4SP", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Caerleon", "LocationZip":"NP18 1AZ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Camberley", "LocationZip":"GU15 2NN", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Chippenham", "LocationZip":"SN15 1HP", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"East Horsley", "LocationZip":"KT24 6QT", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Frome", "LocationZip":"BA11 1EZ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Magherafelt", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sheffield", "LocationZip":"S3 9DA", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Soham", "LocationZip":"CB7 5JD", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Sunbury on Thames", "LocationZip":"TW16 6RH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Yaxley. Peterborough", "LocationZip":"PE7 3JL", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"17039422", "ReferenceType":"result", "ReferenceCitation":"Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23." },{ "ReferencePMID":"25504028", "ReferenceType":"result", "ReferenceCitation":"Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008687", "InterventionMeshTerm":"Metformin" },{ "InterventionMeshId":"D000069450", "InterventionMeshTerm":"Liraglutide" },{ "InterventionMeshId":"C000057619", "InterventionMeshTerm":"Glimepiride" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000054795", "InterventionAncestorTerm":"Incretins" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000000889", "InterventionAncestorTerm":"Anti-Arrhythmia Agents" },{ "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10250", "InterventionBrowseLeafName":"Metformin", "InterventionBrowseLeafAsFound":"Metformin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M419", "InterventionBrowseLeafName":"Liraglutide", "InterventionBrowseLeafAsFound":"Liraglutide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M260523", "InterventionBrowseLeafName":"Glimepiride", "InterventionBrowseLeafAsFound":"Glimepiride", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8637", "InterventionBrowseLeafName":"Hypoglycemic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M26492", "InterventionBrowseLeafName":"Incretins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2794", "InterventionBrowseLeafName":"Anti-Arrhythmia Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" },{ "ConditionMeshId":"D000003924", "ConditionMeshTerm":"Diabetes Mellitus, Type 2" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafAsFound":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }