{"protocolSection":{"identificationModule":{"nctId":"NCT01753362","orgStudyIdInfo":{"id":"1965"},"organization":{"fullName":"University at Buffalo","class":"OTHER"},"briefTitle":"Liraglutide In Overweight Patients With Type 1 Diabetes","officialTitle":"LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES"},"statusModule":{"statusVerifiedDate":"2019-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-12"},"primaryCompletionDateStruct":{"date":"2017-12","type":"ACTUAL"},"completionDateStruct":{"date":"2018-02","type":"ACTUAL"},"studyFirstSubmitDate":"2012-12-17","studyFirstSubmitQcDate":"2012-12-19","studyFirstPostDateStruct":{"date":"2012-12-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-22","resultsFirstSubmitQcDate":"2019-12-03","resultsFirstPostDateStruct":{"date":"2019-12-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-12-03","lastUpdatePostDateStruct":{"date":"2019-12-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Paresh Dandona","investigatorTitle":"MD","investigatorAffiliation":"University at Buffalo"},"leadSponsor":{"name":"University at Buffalo","class":"OTHER"},"collaborators":[{"name":"Juvenile Diabetes Research Foundation","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin."},"conditionsModule":{"conditions":["Type 1 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":84,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"subcutaneous daily injection","interventionNames":["Drug: placebo"]},{"label":"liraglutide","type":"ACTIVE_COMPARATOR","description":"subcutaneous daily injection","interventionNames":["Drug: liraglutide"]}],"interventions":[{"type":"DRUG","name":"liraglutide","armGroupLabels":["liraglutide"]},{"type":"DRUG","name":"placebo","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"HbA1c","description":"The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.","timeFrame":"26 weeks"}],"secondaryOutcomes":[{"measure":"Glucose Concentrations","description":"Mean daily glucose concentrations at baseline and 26 weeks","timeFrame":"26 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1\\) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily. 3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years 6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be \\<30 years. 8) evidence of auto-immunity to beta cells (GAD-65 and islet cell antibody screen)\n\nExclusion Criteria:\n\n1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3)Hepatic disease (transaminase \\> 3 times normal) or cirrhosis; 4)Renal impairment (serum eGFR \\<30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive status; 6)Participation in any other concurrent clinical trial; 7)Any other life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to give informed consent 12) history of gastroparesis 13)history of medullary thyroid carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of smoking for the duration of the study; 15) Use of any agent other than insulin for treatment of diabetes (metformin, pramlintide or thiazolidinediones.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Paresh Dandona, MBBS","affiliation":"SUNY UB","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"diabetes endocrinology center of WNY","city":"Buffalo","state":"New York","zip":"14215","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}},{"facility":"Diabetes Endocrinology Research Center of WNY","city":"Buffalo","state":"New York","zip":"14215","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"subcutaneous daily injection\n\nplacebo"},{"id":"FG001","title":"Liraglutide","description":"subcutaneous daily injection\n\nliraglutide"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"48"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"40"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"subcutaneous daily injection\n\nplacebo"},{"id":"BG001","title":"Liraglutide","description":"subcutaneous daily injection\n\nliraglutide"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"66"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"58"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47","spread":"14.6"},{"groupId":"BG001","value":"47","spread":"13.0"},{"groupId":"BG002","value":"47","spread":"8.0"}]}]}]},{"title":"Sex: Female, 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American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"61"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"66"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"HbA1c","description":"The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent","timeFrame":"26 weeks","groups":[{"id":"OG000","title":"Placebo","description":"subcutaneous daily injection\n\nplacebo"},{"id":"OG001","title":"Liraglutide","description":"subcutaneous daily injection\n\nliraglutide"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"40"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"7.77","spread":"0.83"},{"groupId":"OG001","value":"7.94","spread":"1.05"}]}]},{"title":"26 week","categories":[{"measurements":[{"groupId":"OG000","value":"7.64","spread":"0.84"},{"groupId":"OG001","value":"7.60","spread":"0.98"}]}]}]},{"type":"SECONDARY","title":"Glucose Concentrations","description":"Mean daily glucose concentrations at baseline and 26 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injection\n\nplacebo","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":0,"otherNumAtRisk":26},{"id":"EG001","title":"Liraglutide","description":"subcutaneous daily injection\n\nliraglutide","deathsNumAffected":0,"deathsNumAtRisk":40,"seriousNumAffected":0,"seriousNumAtRisk":40,"otherNumAffected":0,"otherNumAtRisk":40}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Paresh Dandona","organization":"University at Buffalo","email":"dandona@buffalo.edu","phone":"716-535-1850"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis 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and Hormone Antagonists"}]}},"hasResults":true}