{"protocolSection":{"identificationModule":{"nctId":"NCT00135330","orgStudyIdInfo":{"id":"H8O-US-GWAY"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus","officialTitle":"An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-10"},"primaryCompletionDateStruct":{"date":"2008-07","type":"ACTUAL"},"completionDateStruct":{"date":"2008-07","type":"ACTUAL"},"studyFirstSubmitDate":"2005-08-24","studyFirstSubmitQcDate":"2005-08-24","studyFirstPostDateStruct":{"date":"2005-08-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-07-21","resultsFirstSubmitQcDate":"2009-07-21","resultsFirstPostDateStruct":{"date":"2009-08-28","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-19","lastUpdatePostDateStruct":{"date":"2015-04-07","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["diabetes","exenatide","rosiglitazone","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":137,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Arm","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"Exenatide plus Rosiglitazone Arm","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide","Drug: rosiglitazone"]},{"label":"Rosiglitazone Arm","type":"EXPERIMENTAL","interventionNames":["Drug: rosiglitazone"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, 5mcg or 10mcg, twice a day","armGroupLabels":["Exenatide Arm","Exenatide plus Rosiglitazone Arm"],"otherNames":["Byetta"]},{"type":"DRUG","name":"rosiglitazone","description":"oral tablet, 2mg or 4mg, twice a day","armGroupLabels":["Exenatide plus Rosiglitazone Arm","Rosiglitazone Arm"],"otherNames":["Avandia"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in ASIiAUC During a Hyperglycemic Clamp Test.","description":"Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.","timeFrame":"20 weeks"}],"secondaryOutcomes":[{"measure":"Change in AUC for Glucose During a Meal Challenge Test (MCT).","description":"Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Insulin Sensitivity Index as Measured by M-value.","description":"Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Insulin AUC in the First Stage From Baseline to Endpoint.","description":"Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. \"First stage\" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.","timeFrame":"Week 20"},{"measure":"Change in Insulin iAUC From Baseline to Endpoint.","description":"Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. \"First stage\" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.","timeFrame":"Week 20"},{"measure":"Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).","description":"Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.","timeFrame":"Week 20"},{"measure":"Change in AUC for C-peptide During a Meal Challenge Test (MCT).","description":"Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).","description":"Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).","description":"Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).","description":"Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in HbA1c","description":"Change in HbA1c from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting Serum Glucose Concentration.","description":"Change in fasting serum glucose concentration from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting C-peptide","description":"Change in fasting C-peptide from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting Insulin","description":"Change in fasting insulin from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting Proinsulin","description":"Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline","timeFrame":"Week 20"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting Total Cholesterol.","description":"Change in fasting total cholestrol from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting HDL Cholesterol","description":"Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting LDL Cholesterol","description":"Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Fasting Triglycerides","description":"Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.","timeFrame":"Week 20"},{"measure":"Change in Percent Body Fat During a Meal Challenge Test (MCT)","description":"Change in percent body fat from baseline to week 20, as assessed during an MCT","timeFrame":"20 weeks"},{"measure":"Change in Body Fat Mass During a Meal Challenge Test (MCT)","description":"Change in body fat mass form baseline to week 20, as assessed during an MCT","timeFrame":"20 weeks"},{"measure":"Change in Lean Body Mass During a Meal Challenge Test (MCT)","description":"Change in lean body mass from baseline to week 20, as assessed during an MCT","timeFrame":"20 weeks"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline to week 20","timeFrame":"20 weeks"},{"measure":"Change in Hip Circumference","description":"Change in hip circumference form baseline to week 20","timeFrame":"20 weeks"},{"measure":"Change in Waist-to-hip Ratio","description":"Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20","timeFrame":"20 weeks"},{"measure":"Incidence of Hypoglycemia Events","description":"Number of subjects experiencing hypoglycemia at any point during the study","timeFrame":"20 weeks"},{"measure":"Hypoglycemia Rate Per 30 Days Per Patient","description":"Average number of episodes of hypoglycemia per 30 days per patient","timeFrame":"20 weeks"},{"measure":"Pedal Edema Score","description":"Pedal edema scores experienced by each patient throughout the study (\"1+\" indicates a patient experienced a pedal edema score of 1 , 2, or 3; \"2+\" indicates a patient experienced a pedal edema score of 2 or 3, etc.)\n\nScale:\n\n1. Slight pitting, no visible distortion, disappears rapidly\n2. A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds\n3. The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen\n4. The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted","timeFrame":"20 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* HbA1c of 6.8% to 10.0%, inclusive.\n* Body mass index (BMI) of 25 kg/m\\^2 to 40 kg/m\\^2, inclusive.\n\nExclusion Criteria:\n\n* Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors\n* Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.\n* Treated with any of the following medications:\n\n  * Thiazolidinedione within 5 months of screening;\n  * Sulfonylurea within 3 months of screening;\n  * Metformin/sulfonylurea combination therapy within 3 months of screening;\n  * Alpha-glucosidase inhibitor within 3 months of screening;\n  * Meglitinide within 3 months of screening;\n  * Insulin for more than 1 week within the 3 months prior to screening.\n  * Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time\n  * Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility\n  * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start\n  * Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer\n  * Systemic antineoplastic agent\n  * Systemic transplantation medication\n  * Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"James Malone, MD","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Phoenix","state":"Arizona","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Research Site","city":"San Francisco","state":"California","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"Research Site","city":"Jacksonville","state":"Florida","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Research Site","city":"Orlando","state":"Florida","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Research Site","city":"Atlanta","state":"Georgia","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Research Site","city":"Honolulu","state":"Hawaii","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Research Site","city":"Indianapolis","state":"Indiana","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Research Site","city":"Boston","state":"Massachusetts","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Research Site","city":"Pittsfield","state":"Massachusetts","country":"United States","geoPoint":{"lat":42.45008,"lon":-73.24538}},{"facility":"Research Site","city":"Minneapolis","state":"Minnesota","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"Research Site","city":"Rochester","state":"Minnesota","country":"United States","geoPoint":{"lat":44.02163,"lon":-92.4699}},{"facility":"Research Site","city":"Syracuse","state":"New York","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"Research Site","city":"The Bronx","state":"New York","country":"United States","geoPoint":{"lat":40.84985,"lon":-73.86641}},{"facility":"Research Site","city":"Cincinnati","state":"Ohio","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Research Site","city":"League City","state":"Texas","country":"United States","geoPoint":{"lat":29.50745,"lon":-95.09493}},{"facility":"Research Site","city":"New Braunfels","state":"Texas","country":"United States","geoPoint":{"lat":29.703,"lon":-98.12445}},{"facility":"Research Site","city":"San Antonio","state":"Texas","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Research Site","city":"Renton","state":"Washington","country":"United States","geoPoint":{"lat":47.48288,"lon":-122.21707}},{"facility":"Research Site","city":"Spokane","state":"Washington","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}}]},"referencesModule":{"references":[{"pmid":"22236356","type":"DERIVED","citation":"Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10."},{"pmid":"20107105","type":"DERIVED","citation":"DeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC. Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin. Diabetes Care. 2010 May;33(5):951-7. doi: 10.2337/dc09-1521. Epub 2010 Jan 27."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Enrollment occurred between 18 October 2005 and 14 March 2008.","groups":[{"id":"FG000","title":"Exenatide","description":"Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks."},{"id":"FG001","title":"Exenatide Plus Rosiglitazone","description":"Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks."},{"id":"FG002","title":"Rosiglitazone","description":"Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"45"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Patient Decision","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks."},{"id":"BG001","title":"Exenatide Plus Rosiglitazone","description":"Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks."},{"id":"BG002","title":"Rosiglitazone","description":"Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"45"},{"groupId":"BG003","value":"137"}]}],"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"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"109"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"28"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.99","spread":"9.71"},{"groupId":"BG001","value":"54.63","spread":"9.91"},{"groupId":"BG002","value":"55.54","spread":"10.71"},{"groupId":"BG003","value":"55.70","spread":"10.09"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"67"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"70"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in ASIiAUC During a Hyperglycemic Clamp Test.","description":"Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.","populationDescription":"All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"uIU-min/ml","timeFrame":"20 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks."},{"id":"OG001","title":"Exenatide Plus Rosiglitazone","description":"Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks."},{"id":"OG002","title":"Rosiglitazone","description":"Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"15"}]}],"classes":[{"title":"Baseline ASIiAUC","categories":[{"measurements":[{"groupId":"OG000","value":"643.40","spread":"106.71"},{"groupId":"OG001","value":"686.41","spread":"103.70"},{"groupId":"OG002","value":"786.12","spread":"113.60"}]}]},{"title":"Change in ASIiAUC at week 20","categories":[{"measurements":[{"groupId":"OG000","value":"747.26","spread":"187.40"},{"groupId":"OG001","value":"194.68","spread":"181.59"},{"groupId":"OG002","value":"-99.85","spread":"200.04"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.282","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in AUC for Glucose During a Meal Challenge Test (MCT).","description":"Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.","populationDescription":"All patients in full analysis set who have both baseline and endpoint measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol-min/L","timeFrame":"Week 20","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks."},{"id":"OG001","title":"Exenatide Plus Rosiglitazone","description":"Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks."},{"id":"OG002","title":"Rosiglitazone","description":"Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"34"}]}],"classes":[{"title":"Baseline glucose AUC during MCT","categories":[{"measurements":[{"groupId":"OG000","value":"1782.86","spread":"60.47"},{"groupId":"OG001","value":"1799.68","spread":"59.60"},{"groupId":"OG002","value":"1741.87","spread":"60.47"}]}]},{"title":"Change in glucose AUC during MCT at week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-560.12","spread":"50.95"},{"groupId":"OG001","value":"-635.24","spread":"50.25"},{"groupId":"OG002","value":"-425.59","spread":"51.02"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Insulin Sensitivity Index as Measured by M-value.","description":"Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.","populationDescription":"All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/kg-min","timeFrame":"Week 20","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks."},{"id":"OG001","title":"Exenatide Plus Rosiglitazone","description":"Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks."},{"id":"OG002","title":"Rosiglitazone","description":"Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"15"}]}],"classes":[{"title":"M-Value at baseline","categories":[{"measurements":[{"groupId":"OG000","value":"3.89","spread":"0.495"},{"groupId":"OG001","value":"2.49","spread":"0.495"},{"groupId":"OG002","value":"4.02","spread":"0.511"}]}]},{"title":"Change in M-Value from baseline at week 20","categories":[{"measurements":[{"groupId":"OG000","value":"0.477","spread":"0.425"},{"groupId":"OG001","value":"2.07","spread":"0.440"},{"groupId":"OG002","value":"1.42","spread":"0.442"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.308","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Insulin AUC in the First Stage From Baseline to Endpoint.","description":"Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. \"First stage\" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.","populationDescription":"All patients in full analysis set who 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AUC","categories":[{"measurements":[{"groupId":"OG000","value":"200.50","spread":"50.40"},{"groupId":"OG001","value":"136.84","spread":"50.40"},{"groupId":"OG002","value":"157.49","spread":"53.66"}]}]},{"title":"Change from baseline insulin AUC at week 20","categories":[{"measurements":[{"groupId":"OG000","value":"134.88","spread":"31.71"},{"groupId":"OG001","value":"32.12","spread":"31.65"},{"groupId":"OG002","value":"-50.81","spread":"33.59"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.079","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Insulin iAUC From Baseline to Endpoint.","description":"Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. \"First stage\" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.","populationDescription":"All patients in full analysis set who participated 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