{"protocolSection":{"identificationModule":{"nctId":"NCT01473953","orgStudyIdInfo":{"id":"NN9223-3928"},"secondaryIdInfos":[{"id":"U1111-1123-0547","type":"OTHER","domain":"WHO"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects","officialTitle":"Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects. A Randomised, Double-blind, Placebo-controlled Trial Investigating Subcutaneously Single Dose Escalation of a Sustained Release Formulation of Liraglutide Lysine in Healthy Male Subjects"},"statusModule":{"statusVerifiedDate":"2017-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-10"},"primaryCompletionDateStruct":{"date":"2012-03","type":"ACTUAL"},"completionDateStruct":{"date":"2012-03","type":"ACTUAL"},"studyFirstSubmitDate":"2011-11-02","studyFirstSubmitQcDate":"2011-11-14","studyFirstPostDateStruct":{"date":"2011-11-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-06-20","resultsFirstSubmitQcDate":"2013-06-20","resultsFirstPostDateStruct":{"date":"2013-09-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-03-22","lastUpdatePostDateStruct":{"date":"2017-03-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2","Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":31,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cohort 1a: Lira-depot 2.25 mg","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide-depot"]},{"label":"Cohort 2a: Lira-depot 6.75 mg","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide-depot"]},{"label":"Cohort 3a: Lira-depot 15 mg","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide-depot"]},{"label":"Cohort 4a: Lira-depot 30 mg","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide-depot"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"liraglutide-depot","description":"Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.","armGroupLabels":["Cohort 1a: Lira-depot 2.25 mg","Cohort 2a: Lira-depot 6.75 mg","Cohort 3a: Lira-depot 15 mg","Cohort 4a: Lira-depot 30 mg"]},{"type":"DRUG","name":"placebo","description":"Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.","timeFrame":"Day 0 and up to 21 days after treatment"}],"secondaryOutcomes":[{"measure":"Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot","timeFrame":"Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose"},{"measure":"Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot","timeFrame":"Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose"},{"measure":"Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity","timeFrame":"Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose"},{"measure":"Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment","timeFrame":"1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose"},{"measure":"Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment","timeFrame":"0 to 168 hours after dosing"},{"measure":"Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up","timeFrame":"Day 0 and Day 21"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Body mass index (BMI) between 20 and 35 kg/m\\^2 (both inclusive) with a body weight of at least 60 kg\n* Apart from being obese (BMI above 30 kg/m\\^2) the subject has to be considered generally healthy\n\nExclusion Criteria:\n\n* Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders\n* Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy\n* Prescription medicine and non-prescription medicine with few exceptions\n* Current and prior history of alcohol or drug abuse\n* Current smoking of more than 5 cigarettes per day\n* Mental incapacity, language barriers, or unwillingness to comply with the protocol","healthyVolunteers":false,"sex":"MALE","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Evansville","state":"Indiana","zip":"47710","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"It was a Novo Nordisk business decision, and not a decision due to safety concerns, not to continue the development of liraglutide depot. Therefore cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. So no subjects were enrolled for the outcome measure 6.","recruitmentDetails":"The trial was conducted at one site in Evansville, Indiana, USA.","groups":[{"id":"FG000","title":"Cohort 1a: Lira-depot 2.25 mg","description":"In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered."},{"id":"FG001","title":"Cohort 2a: Lira-depot 6.75 mg","description":"In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered."},{"id":"FG002","title":"Cohort 3a: Lira-depot 15 mg","description":"In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered."},{"id":"FG003","title":"Cohort 4a: Lira-depot 30 mg","description":"In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered."},{"id":"FG004","title":"Placebo","description":"In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Cohort 1a: Lira-depot 2.25 mg","description":"In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered."},{"id":"BG001","title":"Cohort 2a: Lira-depot 6.75 mg","description":"In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered."},{"id":"BG002","title":"Cohort 3a: Lira-depot 15 mg","description":"In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered."},{"id":"BG003","title":"Cohort 4a: Lira-depot 30 mg","description":"In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered."},{"id":"BG004","title":"Placebo","description":"In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.)."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"31"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.8","spread":"11.4"},{"groupId":"BG001","value":"30.0","spread":"12.6"},{"groupId":"BG002","value":"29.8","spread":"7.7"},{"groupId":"BG003","value":"39.0","spread":"8.4"},{"groupId":"BG004","value":"28.5","spread":"7.9"},{"groupId":"BG005","value":"32.9","spread":"10.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"31"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. 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Subjects in the safety analysis set contribute to the evaluation 'as treated'.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Day 0 and up to 21 days after treatment","groups":[{"id":"OG000","title":"Cohort 1a: Lira-depot 2.25 mg","description":"In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered."},{"id":"OG001","title":"Cohort 2a: Lira-depot 6.75 mg","description":"In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered."},{"id":"OG002","title":"Cohort 3a: Lira-depot 15 mg","description":"In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered."},{"id":"OG003","title":"Cohort 4a: Lira-depot 30 mg","description":"In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered."},{"id":"OG004","title":"Placebo","description":"In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"8"}]}],"classes":[{"title":"Total adverse events (AEs)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"13"}]}]},{"title":"Serious AE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]},{"title":"Severe AE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"}]}]},{"title":"Moderate AE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"1"}]}]},{"title":"Mild AE","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"12"}]}]},{"title":"Fatal AE","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]}]},{"type":"SECONDARY","title":"Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot","populationDescription":"Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose","groups":[{"id":"OG000","title":"Cohort 1a: Lira-depot 2.25 mg","description":"In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered."},{"id":"OG001","title":"Cohort 2a: Lira-depot 6.75 mg","description":"In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered."},{"id":"OG002","title":"Cohort 3a: Lira-depot 15 mg","description":"In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered."},{"id":"OG003","title":"Cohort 4a: Lira-depot 30 mg","description":"In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered."},{"id":"OG004","title":"Placebo","description":"In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"690","spread":"52","lowerLimit":"52"},{"groupId":"OG001","value":"2141","spread":"25","lowerLimit":"25"},{"groupId":"OG002","value":"6977","spread":"62","lowerLimit":"62"},{"groupId":"OG003","value":"40041","spread":"35","lowerLimit":"35"}]}]}]},{"type":"SECONDARY","title":"Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot","populationDescription":"Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"hours","timeFrame":"Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose","groups":[{"id":"OG000","title":"Cohort 1a: Lira-depot 2.25 mg","description":"In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered."},{"id":"OG001","title":"Cohort 2a: Lira-depot 6.75 mg","description":"In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered."},{"id":"OG002","title":"Cohort 3a: Lira-depot 15 mg","description":"In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered."},{"id":"OG003","title":"Cohort 4a: Lira-depot 30 mg","description":"In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered."},{"id":"OG004","title":"Placebo","description":"In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.13","spread":"92.28","lowerLimit":"92.28"},{"groupId":"OG001","value":"8.09","spread":"55.78","lowerLimit":"55.78"},{"groupId":"OG002","value":"13.74","spread":"22.13","lowerLimit":"22.13"},{"groupId":"OG003","value":"10.46","spread":"24.62","lowerLimit":"24.62"}]}]}]},{"type":"SECONDARY","title":"Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity","populationDescription":"Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. 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Subjects in the safety analysis set contribute to the evaluation 'as treated'.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Day 0 and Day 21","groups":[{"id":"OG000","title":"Cohort 1a: Lira-depot 2.25 mg","description":"In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered."},{"id":"OG001","title":"Cohort 2a: Lira-depot 6.75 mg","description":"In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered."},{"id":"OG002","title":"Cohort 3a: Lira-depot 15 mg","description":"In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered."},{"id":"OG003","title":"Cohort 4a: Lira-depot 30 mg","description":"In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered."},{"id":"OG004","title":"Placebo","description":"In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"8"}]}],"classes":[{"title":"Positive","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]},{"title":"Negative","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)","description":"The safety analysis set includes all subjects who were exposed to at least one dose of trial product. 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