{"protocolSection":{"identificationModule":{"nctId":"NCT01181986","orgStudyIdInfo":{"id":"1-10-CT-31"},"organization":{"fullName":"Carl T. Hayden VA Medical Center","class":"FED"},"briefTitle":"The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes","officialTitle":"Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms"},"statusModule":{"statusVerifiedDate":"2014-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-08"},"primaryCompletionDateStruct":{"date":"2012-12","type":"ACTUAL"},"completionDateStruct":{"date":"2012-12","type":"ACTUAL"},"studyFirstSubmitDate":"2010-08-13","studyFirstSubmitQcDate":"2010-08-13","studyFirstPostDateStruct":{"date":"2010-08-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-12-26","resultsFirstSubmitQcDate":"2014-04-25","resultsFirstPostDateStruct":{"date":"2014-04-28","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-05-12","lastUpdatePostDateStruct":{"date":"2014-05-20","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Juraj Koska","investigatorTitle":"Research Health Scientist","investigatorAffiliation":"Carl T. Hayden VA Medical Center"},"leadSponsor":{"name":"Carl T. Hayden VA Medical Center","class":"FED"},"collaborators":[{"name":"American Diabetes Association","class":"OTHER"},{"name":"Amylin Pharmaceuticals, LLC.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. The results of this study will help to determine and understand a novel action of this group of diabetes medications based on the action of naturally occuring gut substances called incretins. This may have a significant impact on cardiovascular health in patients with early and longstanding diabetes.","detailedDescription":"Two independent, double-blinded, crossover substudies will be conducted to test the effect of exenatide on daylong post-meal and fasting endothelial function. We will measure endothelial function measured by peripheral arterial tonometry (EndoPAT2000, Itamar Inc.). Patients with recent onset (\\<3 years) or established (\\>5 years, Substudy 1 only) diabetes and impaired sugar tolerance (Substudy 2 only) will be studied. The plan is to complete studies in 75 patients (40 in Substudy 1 and 35 in Substudy 2).\n\nIn Substudy 1 patients will get twice a day a skin injection of exenatide (Byetta) or identically looking placebo for 10 days, separated by 14-day period. On the next day after each treatemnt period (day 11), they get just one injection and eat a fat-enriched breakfast. A fatty lunch of similar caloric content will be given 4 hours following the breakfast. Endothelial function will be measured just prior to the injection and every 2 hours for total 8 hours.\n\nIn Substudy 2, patients on 3 different days will get infusion of exenatide withg or without a blocking drug exendin-9, and a control test with placebo without exendin-9. Endothelial function will be measured before the infusion and 2 hours later during the final 15 minutes of the infusion cocktails. Patients will not eat any meal during the test visits."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["Type 2 diabetes mellitus, Impaired glucose tolerance"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":76,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide SC (Sub-study 1)","type":"EXPERIMENTAL","description":"Study groups will be individuals with recent onset (\\<3 years) or established (\\>5 years) T2D. The plan is to achieve 40 complete studies of subcutaneous injection of exenatide BID (Byetta®, 5 or 10 µg) or identically looking Placebo SC for 10 days, separated by 14-day washout period. On the next day after each treatment phase, a single dose of the assigned medication will be injected just before a fat-enriched breakfast meal. A lunch meal of similar caloric and nutrient content will be administered 4 hours following the breakfast meal. Endothelial function will be measured just prior to the injection and every 2 hours during 8-hour post-breakfast period.","interventionNames":["Drug: Exenatide SC","Drug: Placebo SC"]},{"label":"Exenatide IV (Sub-study 2)","type":"EXPERIMENTAL","description":"Study group will be individuals with recent onset (\\<1 year) T2D on diet and impaired glucose tolerance. The plan is to achieve 35 complete studies. The intervention will include 3 randomly ordered visits with intravenous infusion of exenatide in the presence (v1) or absence (v2) of GLP-1 receptor inhibitor exendin-9, and a control test with Placebo IV without exendin-9 (v3). Endothelial function will be measured at baseline and 2 hours later during the final 15 minutes of the infusion cocktails. Study participants will remain fasting during the test visit (3 hours total).","interventionNames":["Drug: Exenatide IV","Drug: Exendin-9","Drug: Placebo IV"]}],"interventions":[{"type":"DRUG","name":"Exenatide SC","description":"Exenatide 5-10 ug sc BID/10 days","armGroupLabels":["Exenatide SC (Sub-study 1)"],"otherNames":["Byetta, exendin-4"]},{"type":"DRUG","name":"Exenatide IV","description":"50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days","armGroupLabels":["Exenatide IV (Sub-study 2)"],"otherNames":["exendin-4, Byetta"]},{"type":"DRUG","name":"Placebo SC","description":"Placebo sc BID/10days","armGroupLabels":["Exenatide SC (Sub-study 1)"],"otherNames":["placebo"]},{"type":"DRUG","name":"Exendin-9","description":"Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.","armGroupLabels":["Exenatide IV (Sub-study 2)"],"otherNames":["exendin-(9-39)"]},{"type":"DRUG","name":"Placebo IV","description":"Intravenous infusion for 45 minutes on 1 out of 3 visits","armGroupLabels":["Exenatide IV (Sub-study 2)"],"otherNames":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Reactive Hyperemia Index (RHI)","description":"Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.","timeFrame":"0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)"}],"secondaryOutcomes":[{"measure":"Plasma Triglycerides","description":"Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.","timeFrame":"0, 2, 4, 6 and 8 hours post-study drug on day 11"},{"measure":"Plasma Glucose","description":"Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.","timeFrame":"0, 2, 4, 6, and 8 hours post-study drug on day 11"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* US Veterans\n* type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)\n* T2D diagnosed ≥ 5 years prior to study enrollment\n* Impaired glucose tolerance\n\nExclusion Criteria:\n\n* T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values\n* known or suspected T1D (early onset age, low body mass index, lack of family history)\n* TZD use in the prior 3 months\n* prior regular use of insulin\n* Creatinine \\>2.0 mg/dl or other laboratory or clinical evidence of kidney disease\n* anemia\n* known active liver disease or hepatic enzyme elevation two-and-a half times above normal\n* acute bacterial or viral illness or evidence of other active infection in the past 4 weeks\n* stable or unstable angina or other major illness in the past 6 months\n* Raynaud's disease or any rheumatic disease affecting fingers\n* current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (\\>1 g/day);\n* subjects receiving lipid lowering or anti-hypertension medications must be on stable doses for at least 2 months prior to participation.","healthyVolunteers":false,"sex":"ALL","minimumAge":"35 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Juraj Koska, MD, PhD","affiliation":"Phoenix VA Healthcare System","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Phoenix VA Medical Center","city":"Phoenix","state":"Arizona","zip":"85012","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Then Placebo (Sub-study 1)","description":"Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested."},{"id":"FG001","title":"Placebo Then Exenatide (Sub-study 1)","description":"Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested."},{"id":"FG002","title":"Exenatide IV (Sub-study 2)","description":"Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo"}],"periods":[{"title":"Phase 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"Saline+Exenatide","achievements":[{"groupId":"FG000","comment":"N/A for this arm","numSubjects":"0"},{"groupId":"FG001","comment":"N/A for this arm","numSubjects":"0"},{"groupId":"FG002","numSubjects":"32"}]},{"type":"Saline+Placebo","achievements":[{"groupId":"FG000","comment":"N/A for this arm","numSubjects":"0"},{"groupId":"FG001","comment":"N/A for this arm","numSubjects":"0"},{"groupId":"FG002","numSubjects":"33"}]},{"type":"Exendin-9+Exenatide","achievements":[{"groupId":"FG000","comment":"N/A for this arm","numSubjects":"0"},{"groupId":"FG001","comment":"N/A for this arm","numSubjects":"0"},{"groupId":"FG002","numSubjects":"33"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"32"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Phase 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","comment":"N/A for Sub-study 2","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Medical condition","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sub-study 1: Exenatide SC","description":"Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study"},{"id":"BG001","title":"Sub-study 2: Exenatide IV","description":"Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"76"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62","spread":"6"},{"groupId":"BG001","value":"60","spread":"6"},{"groupId":"BG002","value":"61","spread":"6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"74"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"65"}]},{"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":"Body mass index","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33","spread":"6"},{"groupId":"BG001","value":"33","spread":"12"},{"groupId":"BG002","value":"33","spread":"9"}]}]}]},{"title":"Glycated hemoglobin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"%","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.6","spread":"0.9"},{"groupId":"BG001","value":"6.1","spread":"0.5"},{"groupId":"BG002","value":"6.4","spread":"0.8"}]}]}]},{"title":"Diabetes duration (years)","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6","lowerLimit":"1","upperLimit":"9"},{"groupId":"BG001","value":"0","lowerLimit":"0","upperLimit":"1"},{"groupId":"BG002","value":"6","lowerLimit":"1","upperLimit":"9"}]}]}]},{"title":"Systolic BP","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"128","spread":"8"},{"groupId":"BG001","value":"125","spread":"12"},{"groupId":"BG002","value":"127","spread":"14"}]}]}]},{"title":"Diastolic BP (mmHg)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"78","spread":"8"},{"groupId":"BG001","value":"80","spread":"8"},{"groupId":"BG002","value":"79","spread":"8"}]}]}]},{"title":"History of hypertension","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"49"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"27"}]}]}]},{"title":"Lipid-lowering therapy","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"20"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"56"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Reactive Hyperemia Index (RHI)","description":"Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)","groups":[{"id":"OG000","title":"Exenatide (Subs-study 1)","description":"Exenatide: Exenatide 5-10 ug sc BID/10 days"},{"id":"OG001","title":"Placebo (Sub-study 1)","description":"Placebo sc BID for 10 days"},{"id":"OG002","title":"Saline+Exenatide (Sub-study 2)","description":"Infusion of saline (min 0-75), added exenatide infusion (min 30-75)"},{"id":"OG003","title":"Saline+Placebo (Sub-study 2)","description":"Infusion of saline (min 0-75), added placebo infusion (min 30-75)"},{"id":"OG004","title":"Exendin-9+Exenatide (Sub-study 2)","description":"Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"32"},{"groupId":"OG004","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.90","spread":"0.005"},{"groupId":"OG001","value":"1.79","spread":"0.05"},{"groupId":"OG002","value":"2.24","spread":"0.07"},{"groupId":"OG003","value":"1.95","spread":"0.07"},{"groupId":"OG004","value":"1.99","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment sequence, group (diabetes duration) and time."},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.006","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment sequence."},{"groupIds":["OG002","OG004"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment sequence."}]},{"type":"SECONDARY","title":"Plasma Triglycerides","description":"Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dl","timeFrame":"0, 2, 4, 6 and 8 hours post-study drug on day 11","groups":[{"id":"OG000","title":"Exenatide (Sub-study 1)","description":"Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested."},{"id":"OG001","title":"Placebo (Sub-study 1)","description":"Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"175","spread":"14"},{"groupId":"OG001","value":"230","spread":"14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment sequence and diabetes duration group."}]},{"type":"SECONDARY","title":"Plasma Glucose","description":"Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dl","timeFrame":"0, 2, 4, 6, and 8 hours post-study drug on day 11","groups":[{"id":"OG000","title":"Exenatide (Sub-study 1)","description":"Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested."},{"id":"OG001","title":"Placebo (Sub-study 1)","description":"Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"115","spread":"5"},{"groupId":"OG001","value":"136","spread":"5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Exenatide SC (Sub-study 1)","description":"Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11","seriousNumAffected":0,"seriousNumAtRisk":41,"otherNumAffected":16,"otherNumAtRisk":41},{"id":"EG001","title":"Placebo SC (Sub-study 1)","description":"Placebo sc BID/10days, AM dose and meal test on day 11","seriousNumAffected":0,"seriousNumAtRisk":41,"otherNumAffected":3,"otherNumAtRisk":41},{"id":"EG002","title":"Saline+Exenatide IV (Sub-study 2)","description":"Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)","seriousNumAffected":0,"seriousNumAtRisk":32,"otherNumAffected":0,"otherNumAtRisk":32},{"id":"EG003","title":"Saline+Placebo (Sub-study 2)","description":"Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)","seriousNumAffected":1,"seriousNumAtRisk":33,"otherNumAffected":0,"otherNumAtRisk":33},{"id":"EG004","title":"Exendin-9+Exenatide IV (Sub-study 2)","description":"Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)","seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":0,"otherNumAtRisk":33}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"The event occured 13 days after the test visit during which patient received intravenous infusion of saline with placebo. The event was considered unrelated to the study per IRB decision.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":41},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":14,"numAtRisk":41},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":41},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":41},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":41},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Juraj Koska","organization":"Phoenix VA Health Care System","email":"juraj.koska@va.gov","phone":"602-277-5551","phoneExt":"7685"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D018149","term":"Glucose Intolerance"}],"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":"D006943","term":"Hyperglycemia"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"},{"id":"C083773","term":"exendin (9-39)"}],"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}