{ "FullStudy":{ "Rank":218180, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511692", "OrgStudyIdInfo":{ "OrgStudyId":"NN2211-1589" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2006-000377-30", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes", "OfficialTitle":"A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2005" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2007", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2007", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 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 effects of liraglutide on energy intake in subjects with type 2 diabetes." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Diabetes Mellitus, Type 2" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"43", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Lira --> placebo", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo" ] } },{ "ArmGroupLabel":"Placebo --> glim", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: placebo", "Drug: glimepiride" ] } },{ "ArmGroupLabel":"Glim --> lira", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: glimepiride" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"1.8 mg/day injected subcutaneously for 4 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Glim --> lira", "Lira --> placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"Liraglutide placebo, injected subcutaneously for 4 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Lira --> placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo --> glim" ] } },{ "InterventionType":"Drug", "InterventionName":"glimepiride", "InterventionDescription":"Dose individually adjusted, administered orally for 4 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Glim --> lira", "Placebo --> glim" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10" },{ "SecondaryOutcomeMeasure":"Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10" },{ "SecondaryOutcomeMeasure":"Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10" },{ "SecondaryOutcomeMeasure":"Total duration of eating at the buffet meal (satiation)" },{ "SecondaryOutcomeMeasure":"Weight" },{ "SecondaryOutcomeMeasure":"Waist circumference" },{ "SecondaryOutcomeMeasure":"Adverse events" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nType 2 diabetes mellitus\nDiet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy\nHbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)\nBody mass index (BMI) between 27-40 kg/m^2 (both inclusive)\nSubjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)\nEuthyroid subjects\nSubjects should be unrestrained eaters\n\nExclusion Criteria:\n\nRecurrent severe hypoglycaemia\nImpaired liver function\nImpaired renal function\nCardiac problems\nUncontrolled treated/untreated hypertension\nKnown or suspected allergy to trial products or related products\nUse of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight\nActive hepatitis B and/or active hepatitis C\nPositive HIV (human immunodeficiency virus) antibodies\nKnown or suspected abuse of alcohol or narcotics\nHabitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 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":"Adelaide", "LocationState":"South Australia", "LocationZip":"5005", "LocationCountry":"Australia" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Neuss", "LocationZip":"41460", "LocationCountry":"Germany" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"22446097", "ReferenceType":"result", "ReferenceCitation":"Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "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":"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" } ] } } } } } }