{"protocolSection":{"identificationModule":{"nctId":"NCT00456300","orgStudyIdInfo":{"id":"H-16488"},"organization":{"fullName":"Montefiore Medical Center","class":"OTHER"},"briefTitle":"Role of Exenatide in Type 1 Diabetes","officialTitle":"The Role of Exenatide in Type 1 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2019-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-03","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2009-03","type":"ACTUAL"},"completionDateStruct":{"date":"2009-03","type":"ACTUAL"},"studyFirstSubmitDate":"2007-04-03","studyFirstSubmitQcDate":"2007-04-03","studyFirstPostDateStruct":{"date":"2007-04-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-03-13","resultsFirstSubmitQcDate":"2019-02-01","resultsFirstPostDateStruct":{"date":"2019-02-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-02-01","lastUpdatePostDateStruct":{"date":"2019-02-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Rubina Heptulla","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Montefiore Medical Center"},"leadSponsor":{"name":"Montefiore Medical Center","class":"OTHER"},"collaborators":[{"name":"National Institutes of Health (NIH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.","detailedDescription":"A large study in people with type 1 diabetes (T1DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.\n\nIn people without diabetes, the \"after meal\" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. It is now known that a substance made by the body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to \"dampen\" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of food in the stomach. Lastly, it seems to \"dampen\" the appetite, which causes a person to eat less.\n\nExenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is FDA approved for use in adults.\n\nStudy Design: Followed by a baseline study with insulin alone, subjects were randomized to two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded randomized controlled manner, along with insulin as a single subcutaneous injection. Studies were at least 3 weeks apart.\n\nBaseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat), enriched with 1 g of \\[13C\\] glucose within 10 min. Breath samples for 13CO2 analysis were collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine were maintained during study.\n\nOn the days subjects received the study drug of 1.25 µ,g (\\~0.02 µ,g/kg) or 2.5 µ,g (\\~0.04 µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%.\n\nMeasurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the exenatide treated groups vs. insulin monotherapy."},"conditionsModule":{"conditions":["Type 1 Diabetes"],"keywords":["Hypoglycemia","Hyperglycemia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":11,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide 1.25 mcg + Insulin","type":"EXPERIMENTAL","description":"In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection","interventionNames":["Drug: Exenatide","Drug: Insulin"]},{"label":"Exenatide 2.5 mcg + Insulin","type":"EXPERIMENTAL","description":"In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection","interventionNames":["Drug: Exenatide","Drug: Insulin"]},{"label":"Insulin","type":"ACTIVE_COMPARATOR","description":"Each subject received a baseline study with insulin alone","interventionNames":["Drug: Insulin"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.","armGroupLabels":["Exenatide 1.25 mcg + Insulin","Exenatide 2.5 mcg + Insulin"],"otherNames":["Byetta"]},{"type":"DRUG","name":"Insulin","description":"Each subject received a baseline study with insulin alone","armGroupLabels":["Exenatide 1.25 mcg + Insulin","Exenatide 2.5 mcg + Insulin","Insulin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone","description":"Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection","timeFrame":"0-120 minutes post-dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n\\*\\*\\*Subjects must be patients of the Texas Children's Hospital Diabetes Care Center\\*\\*\\*.\n\nAll of the following criteria must be met:\n\n1. Between 12-21 years of age at the time of enrollment.\n2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).\n3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.\n4. Menstruating women must have a negative pregnancy test.\n5. Hemoglobin equal to or greater than 12 g/dL before each study.\n6. Weight greater than 44 kg.\n7. Tanner stage greater than 3\n\nExclusion Criteria:\n\n1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism; stable on medications.\n2. Lack of a supportive family environment as detected by the clinicians and/or social workers.\n3. Positive pregnancy test in menstruating young women.\n4. BMI greater than 90th percentile for age or less than 10th percentile for age.\n5. Lactating and nursing mothers.","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"21 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Rubina Heptulla, MD","affiliation":"Montefiore Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Texas Children's Hospital/ Baylor College of Medicine","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}}]},"referencesModule":{"references":[{"pmid":"20332358","type":"DERIVED","citation":"Raman VS, Mason KJ, Rodriguez LM, Hassan K, Yu X, Bomgaars L, Heptulla RA. The role of adjunctive exenatide therapy in pediatric type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1294-6. doi: 10.2337/dc09-1959. Epub 2010 Mar 23."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Two subjects failed screening and could not be randomized to particiapate.","recruitmentDetails":"11 subjects were enrolled into the study. Of these, 9 subjects were randomized and only 8 subjects completed this three part study. These subjects were recruited from the diabetes clinics.","groups":[{"id":"FG000","title":"Insulin First, Then Exenatide1.25 mcg, Then Exenatide 2.5 mcg","description":"Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 1.25 mcg + Insulin or Exenatide 2.5 mcg + Insulin"},{"id":"FG001","title":"Insulin First, Then Exenatide 2.5 mcg, Then Exenatide 1.25 mcg","description":"Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 2.5 mcg + Insulin or Exenatide 1.25 mcg + Insulin"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","comment":"\"Started\" means recruited, not enrolled.","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"All Study Participants","description":"Following the baseline study with insulin, Participants were randomized to receive either Exenatide 1.25 mcg or Exenatide 2.5 mcg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"9"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17","spread":"1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"5"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone","description":"Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection","populationDescription":"All participants who received at least one dose of each intervention and completed all study visits were included in the analyses. Only 8 subjects completed all study visits and one dropped out during the second study visit.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol*L/min","timeFrame":"0-120 minutes post-dose","groups":[{"id":"OG000","title":"Exenatide 1.25 mcg + Insulin","description":"Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection"},{"id":"OG001","title":"Exenatide 2.5 mcg + Insulin","description":"Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection"},{"id":"OG002","title":"Insulin Monotherapy","description":"Participants who received Insulin alone as a single subcutaneous injection, part of baseline study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49","spread":"156"},{"groupId":"OG001","value":"44","spread":"281"},{"groupId":"OG002","value":"379","spread":"259"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"0-120 minutes post-dose","eventGroups":[{"id":"EG000","title":"Exenatide 1.25 mcg + Insulin","description":"Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":1,"otherNumAtRisk":9},{"id":"EG001","title":"Exenatide 2.5 mcg + Insulin","description":"Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":0,"otherNumAtRisk":9},{"id":"EG002","title":"Insulin Monotherapy","description":"Participants who received Insulin alone as a single subcutaneous injection, as part of the baseline study visit","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":0,"otherNumAtRisk":9}],"otherEvents":[{"term":"Hypoglycemia","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Rubina Heptulla","organization":"Montefiore Medical College","email":"rubhep@gmail.com","phone":"832824000"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003922","term":"Diabetes Mellitus, Type 1"},{"id":"D007003","term":"Hypoglycemia"},{"id":"D006943","term":"Hyperglycemia"}],"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":"D001327","term":"Autoimmune Diseases"},{"id":"D007154","term":"Immune System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"},{"id":"D007328","term":"Insulin"}],"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"},{"id":"D011384","term":"Proinsulin"},{"id":"D061385","term":"Insulins"},{"id":"D010187","term":"Pancreatic Hormones"},{"id":"D036361","term":"Peptide Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}},"hasResults":true}