{ "FullStudy":{ "Rank":218218, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511198", "OrgStudyIdInfo":{ "OrgStudyId":"NN2211-2072" }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent", "OfficialTitle":"NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2001" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2001", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2001", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 25, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 26, 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 the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA)." }, "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":"223", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"0.045 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } },{ "ArmGroupLabel":"0.225 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } },{ "ArmGroupLabel":"0.45 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } },{ "ArmGroupLabel":"0.60 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } },{ "ArmGroupLabel":"0.75 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } },{ "ArmGroupLabel":"Met", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: metformin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"Injected subcutaneously once daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "0.045 mg", "0.225 mg", "0.45 mg", "0.60 mg", "0.75 mg" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "NNC 90-1170" ] } },{ "InterventionType":"Drug", "InterventionName":"metformin", "InterventionDescription":"1000 mg twice daily, administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Met" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Body weight" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"FPG (fasting plasma glucose)" },{ "SecondaryOutcomeMeasure":"HbA1c (glycosylated haemoglobin)" },{ "SecondaryOutcomeMeasure":"Fructosamine" },{ "SecondaryOutcomeMeasure":"Lipids" },{ "SecondaryOutcomeMeasure":"Adverse events" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nType 2 diabetic\nTreated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed\nBody Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)\nHbA1c maximum 10% based on analysis from central laboratory\n\nExclusion Criteria:\n\nCardiac problems\nUncontrolled treated/untreated hypertension\nProliferative retinopathy or known autonomic neuropathy\nRecurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed\nKnown or suspected abuse of alcohol or narcotics\nCurrent treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness\nTSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL\nType 1 or other specific causes of diabetes", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 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":"Vestavia", "LocationState":"Alabama", "LocationZip":"35209", "LocationCountry":"United States" },{ "LocationFacility":"Novo 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"LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Trumbull", "LocationState":"Connecticut", "LocationZip":"06611", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Jacksonville", "LocationState":"Florida", "LocationZip":"32216", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Melbourne", "LocationState":"Florida", "LocationZip":"32901", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Miami", "LocationState":"Florida", "LocationZip":"33156", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Ocala", "LocationState":"Florida", "LocationZip":"34471", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Pembroke Pines", 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"LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Durham", "LocationState":"North Carolina", "LocationZip":"27710", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Oklahoma City", "LocationState":"Oklahoma", "LocationZip":"73104", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Chattanooga", "LocationState":"Tennessee", "LocationZip":"37404", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Corpus Christi", "LocationState":"Texas", "LocationZip":"78404", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75230", "LocationCountry":"United States" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Dallas", 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Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Diabet Med. 2005 Aug;22(8):1016-23." },{ "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" } ] }, "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" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10250", "InterventionBrowseLeafName":"Metformin", "InterventionBrowseLeafAsFound":"Metformin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M419", "InterventionBrowseLeafName":"Liraglutide", "InterventionBrowseLeafAsFound":"Liraglutide", "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" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "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":"M11284", "ConditionBrowseLeafName":"Obesity", "ConditionBrowseLeafRelevance":"low" },{ "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":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" } ] } } } } } }