{
  "FullStudy":{
    "Rank":217832,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516255",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NN2211-1644"
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Effect of Liraglutide on Heart Frequency in Healthy Volunteers",
          "OfficialTitle":"A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"July 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2006",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2006",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 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 the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control."
        },
        "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":"64",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Double-blind / liraglutide",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide",
                    "Drug: placebo",
                    "Procedure: electrocardiogram (ECG)"
                  ]
                }
              },{
                "ArmGroupLabel":"Double-blind / placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide",
                    "Drug: placebo",
                    "Procedure: electrocardiogram (ECG)"
                  ]
                }
              },{
                "ArmGroupLabel":"Open-label / moxifloxacin",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: moxifloxacin",
                    "Procedure: electrocardiogram (ECG)"
                  ]
                }
              },{
                "ArmGroupLabel":"Open-label / placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: placebo",
                    "Procedure: electrocardiogram (ECG)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"liraglutide",
                "InterventionDescription":"0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Double-blind / liraglutide",
                    "Double-blind / placebo"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"placebo",
                "InterventionDescription":"Injected subcutaneously. Subjects are randomly allocated to two treatment sequences",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Double-blind / liraglutide",
                    "Double-blind / placebo"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"moxifloxacin",
                "InterventionDescription":"Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Open-label / moxifloxacin"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"placebo",
                "InterventionDescription":"Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Open-label / placebo"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"electrocardiogram (ECG)",
                "InterventionDescription":"24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Double-blind / liraglutide",
                    "Double-blind / placebo"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"electrocardiogram (ECG)",
                "InterventionDescription":"Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Open-label / moxifloxacin",
                    "Open-label / placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Maximum time-matched mean difference between the baseline subtracted QTci intervals"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"QTc at liraglutide tmax (time to reach maximum concentration)"
              },{
                "SecondaryOutcomeMeasure":"Percentage subjects with QTc at least 450, 480 and 500 milliseconds"
              },{
                "SecondaryOutcomeMeasure":"Moxifloxacin maximum time-matched mean change QTc and QTci"
              },{
                "SecondaryOutcomeMeasure":"Cmax, maximum concentration of liraglutide"
              },{
                "SecondaryOutcomeMeasure":"tmax, time to reach Cmax of liraglutide"
              },{
                "SecondaryOutcomeMeasure":"Vitals signs: Blood pressure"
              },{
                "SecondaryOutcomeMeasure":"Vital signs: Pulse"
              },{
                "SecondaryOutcomeMeasure":"Serial electrocardiography"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy\nFasting plasma glucose within normal limits (80-100 mg/dl)\nBMI (Body Mass Index): 20.0-29.0 kg/m^2 (inclusive)\nHeart rate within the range of 50-90 beats per minute (inclusive)\nSubject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data\n\nExclusion Criteria:\n\nAny clinically significant disease history, in the opinion of the investigator, of systemic or organ disease\nAny clinically significant disease history, in the opinion of the investigator, of cardiovascular disease\nClinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening\nA family history of sudden cardiac death at age less than 50 years old\nT-wave abnormalities\nIndividual or familial history of long QT Syndrome\nPositive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody\nPositive results on the urine drug and alcohol screen\nAny regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening\nAny strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period\nBlood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing\nSubject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months\nExcessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate)\nFemales who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures\nA history (within the last 2 years) of drug or alcohol abuse",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 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":"Fargo",
                "LocationState":"North Dakota",
                "LocationZip":"58104",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"19737980",
                "ReferenceType":"result",
                "ReferenceCitation":"Chatterjee DJ, Khutoryansky N, Zdravkovic M, Sprenger CR, Litwin JS. Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes. J Clin Pharmacol. 2009 Nov;49(11):1353-62. doi: 10.1177/0091270009339189. Epub 2009 Sep 8."
              }
            ]
          },
          "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":"D000077266",
                "InterventionMeshTerm":"Moxifloxacin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000900",
                "InterventionAncestorTerm":"Anti-Bacterial Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000059005",
                "InterventionAncestorTerm":"Topoisomerase II Inhibitors"
              },{
                "InterventionAncestorId":"D000059003",
                "InterventionAncestorTerm":"Topoisomerase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000054795",
                "InterventionAncestorTerm":"Incretins"
              },{
                "InterventionAncestorId":"D000006728",
                "InterventionAncestorTerm":"Hormones"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1722",
                "InterventionBrowseLeafName":"Moxifloxacin",
                "InterventionBrowseLeafAsFound":"Moxifloxacin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M419",
                "InterventionBrowseLeafName":"Liraglutide",
                "InterventionBrowseLeafAsFound":"Liraglutide",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M140649",
                "InterventionBrowseLeafName":"Norgestimate, ethinyl estradiol drug combination",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "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":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Hypo",
                "InterventionBrowseBranchName":"Hypoglycemic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Repr",
                "InterventionBrowseBranchName":"Reproductive Control 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"
              }
            ]
          }
        }
      }
    }
  }
}