{ "FullStudy":{ "Rank":217883, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515592", "OrgStudyIdInfo":{ "OrgStudyId":"NN2211-1694" }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers", "OfficialTitle":"A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2006", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2006", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 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 Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects." }, "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":"24", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"15 mcg/kg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo" ] } },{ "ArmGroupLabel":"20 mcg/kg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo" ] } },{ "ArmGroupLabel":"25 mcg/kg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "15 mcg/kg" ] } },{ "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "20 mcg/kg" ] } },{ "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "25 mcg/kg" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "15 mcg/kg", "20 mcg/kg", "25 mcg/kg" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Adverse events" },{ "PrimaryOutcomeMeasure":"Body weight" },{ "PrimaryOutcomeMeasure":"Antibody against liraglutide" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Area under the plasma liraglutide concentration curve" },{ "SecondaryOutcomeMeasure":"Cmax, maximum concentration" },{ "SecondaryOutcomeMeasure":"tmax, time to reach Cmax" },{ "SecondaryOutcomeMeasure":"Terminal elimination rate constant" },{ "SecondaryOutcomeMeasure":"t½, terminal elimination half-life" },{ "SecondaryOutcomeMeasure":"24-hour profiles of plasma glucose" },{ "SecondaryOutcomeMeasure":"24-hour profiles of serum insulin" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy Japanese subjects\nBMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive\n\nExclusion Criteria:\n\nAny clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening\nPresence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders\nHepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive\nHistory of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders\nHistory of significant allergy or hypersensitivity\nKnown or suspected allergy to trial product or related products\nHistory of drug or alcohol abuse\nThe subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"20 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "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":"Tokyo", "LocationZip":"1000005", "LocationCountry":"Japan" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"18541123", "ReferenceType":"result", "ReferenceCitation":"Irie S, Matsumura Y, Zdravkovic M, Jacobsen LV, Kageyama S. Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Int J Clin Pharmacol Ther. 2008 Jun;46(6):273-9." } ] }, "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" } ] }, "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":"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":"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" } ] } } } } } }