{"protocolSection":{"identificationModule":{"nctId":"NCT01154933","orgStudyIdInfo":{"id":"1930"},"organization":{"fullName":"University at Buffalo","class":"OTHER"},"briefTitle":"Exeantide in Type 2 Diabetes on Insulin","officialTitle":"The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin"},"statusModule":{"statusVerifiedDate":"2022-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-04"},"primaryCompletionDateStruct":{"date":"2011-11","type":"ACTUAL"},"completionDateStruct":{"date":"2011-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-06-30","studyFirstSubmitQcDate":"2010-06-30","studyFirstPostDateStruct":{"date":"2010-07-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-03-08","resultsFirstSubmitQcDate":"2022-09-08","resultsFirstPostDateStruct":{"date":"2022-10-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-09-08","lastUpdatePostDateStruct":{"date":"2022-10-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Paresh Dandona","investigatorTitle":"MD","investigatorAffiliation":"Kaleida Health"},"leadSponsor":{"name":"University at Buffalo","class":"OTHER"},"collaborators":[{"name":"Amylin Pharmaceuticals, LLC.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.\n\nThe purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["type 2 diabetes","obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"exenatide 5 mcg","type":"EXPERIMENTAL","description":"exenatide 5 mcg","interventionNames":["Drug: exenatide 5 mcg"]},{"label":"exenatide 10 mcg","type":"EXPERIMENTAL","description":"exenatide 10 mcg","interventionNames":["Drug: exenatide 10 mcg"]},{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"placebo","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"exenatide 5 mcg","description":"exenatide 5 mcg","armGroupLabels":["exenatide 5 mcg"]},{"type":"DRUG","name":"exenatide 10 mcg","description":"exenatide 10 mcg","armGroupLabels":["exenatide 10 mcg"]},{"type":"DRUG","name":"placebo","description":"saline sq","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Fasting Insulin","description":"To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.","timeFrame":"after 24 hours fast at baseline and 12 weeks"}],"secondaryOutcomes":[{"measure":"Weight","description":"To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients","timeFrame":"value at 12 weeks minus value at baseline"},{"measure":"HbA1c","description":"To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.","timeFrame":"value at 12 weeks minus value at baseline"},{"measure":"Intranuclear NFκB Binding Activity","description":"Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group","timeFrame":"measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Males or females 20-75 years of age inclusive.\n* Type 2 diabetes\n* On insulin therapy\n* HbA1c ≥7.5% and ≤ 9%\n* BMI ≥ 30 kg/m2\n* Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.\n\nExclusion Criteria:\n\n* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks\n* Pregnancy\n* Hepatic disease (abnormal LFT's)\n* Use of DPP4 inhibitors.\n* Renal impairment (serum creatinine \\> 1.5)\n* Participation in any other concurrent clinical trial\n* Any other life-threatening, non-cardiac disease\n* Uncontrolled hypertension (BP \\> 160/100 mm of Hg)\n* Congestive Heart Failure.\n* Use of an investigational agent or therapeutic regimen within 30 days of study","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Paresh Dandona, MBBS","affiliation":"SUNY at Buffalo","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Millard Fillmore Gates Hospital","city":"Buffalo","state":"New York","zip":"14209","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}}]},"referencesModule":{"references":[{"pmid":"29346597","type":"DERIVED","citation":"Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2-Keap-1-Regulated Antioxidant Enzymes: Relevance to beta-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The exenatide 10mcg group started on 5mcg for a single dose study (samples collected were at 0, 2, 4, and 6 hours)","groups":[{"id":"FG000","title":"Exenatide","description":"Period 1 = 5 mcg Period 2 = 10 mcg"},{"id":"FG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq"}],"periods":[{"title":"Exenatide 5 mcg","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Exenatide 10 mcg","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide 10 mcg","description":"exenatide 5mcg and then exenatide 10 mcg"},{"id":"BG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"56","spread":"3"},{"groupId":"BG001","value":"54","spread":"4"},{"groupId":"BG002","value":"55","spread":"3"}]}]}]},{"title":"Sex/Gender, Customized","populationDescription":"Data was not collected","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Sex/Gender Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"BMI","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m²","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"39.8","spread":"2"},{"groupId":"BG001","value":"39.1","spread":"1.6"},{"groupId":"BG002","value":"39.5","spread":"1.8"}]}]}]},{"title":"HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"%","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.6","spread":"0.4"},{"groupId":"BG001","value":"8.5","spread":"0.3"},{"groupId":"BG002","value":"8.55","spread":"0.4"}]}]}]},{"title":"Fasting Blood Glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"139","spread":"17"},{"groupId":"BG001","value":"128","spread":"13"},{"groupId":"BG002","value":"133","spread":"15"}]}]}]},{"title":"FFA","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mM","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0.69","spread":"0.07"},{"groupId":"BG001","value":"0.64","spread":"0.08"},{"groupId":"BG002","value":"0.66","spread":"0.08"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Fasting Insulin","description":"To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"μU/mL","timeFrame":"after 24 hours fast at baseline and 12 weeks","groups":[{"id":"OG000","title":"Exenatide 10 mcg","description":"exenatide 10 mcg\n\nexenatide 10 mcg: exenatide 10 mcg"},{"id":"OG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"title":"At Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"12.7","spread":"2.8"},{"groupId":"OG001","value":"13.1","spread":"3.1"}]}]},{"title":"At 12 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"16.4","spread":"3.2"},{"groupId":"OG001","value":"13.9","spread":"5.9"}]}]}]},{"type":"SECONDARY","title":"Weight","description":"To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"lbs","timeFrame":"value at 12 weeks minus value at baseline","groups":[{"id":"OG000","title":"Exenatide 10 mcg","description":"exenatide 10 mcg\n\nexenatide 10 mcg: exenatide 10 mcg"},{"id":"OG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"20"},{"groupId":"OG001","value":"3","spread":"18"}]}]}]},{"type":"SECONDARY","title":"HbA1c","description":"To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent","timeFrame":"value at 12 weeks minus value at baseline","groups":[{"id":"OG000","title":"Exenatide 10 mcg","description":"exenatide 10 mcg\n\nexenatide 10 mcg: exenatide 10 mcg"},{"id":"OG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"0.5"},{"groupId":"OG001","value":"-0.5","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Intranuclear NFκB Binding Activity","description":"Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"% ratio of NFKB/Oct-1","timeFrame":"measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline","groups":[{"id":"OG000","title":"Exenatide 10 mcg","description":"exenatide 10 mcg\n\nexenatide 10 mcg: exenatide 10 mcg"},{"id":"OG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26","spread":"7"},{"groupId":"OG001","value":"0","spread":"7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"participants were monitored/assessed for possible adverse events, but none occurred","eventGroups":[{"id":"EG000","title":"Exenatide 5mcg Then Exenatide 10 mcg","description":"given exenatide 5mcg followed by exenatide 10mcg","seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":0,"otherNumAtRisk":12},{"id":"EG001","title":"Placebo","description":"placebo\n\nplacebo: saline sq","seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":0,"otherNumAtRisk":12}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Paresh Dandona","organization":"State University of NY at Buffalo","email":"dandona@buffalo.edu","phone":"7165351850"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D009765","term":"Obesity"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"}],"ancestors":[{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D014688","term":"Venoms"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D014118","term":"Toxins, Biological"},{"id":"D001685","term":"Biological Factors"}]}},"hasResults":true}