{"protocolSection":{"identificationModule":{"nctId":"NCT00359762","orgStudyIdInfo":{"id":"H8O-EW-GWBE"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Exenatide Versus Glimepiride in Patients With Type 2 Diabetes","officialTitle":"Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)"},"statusModule":{"statusVerifiedDate":"2015-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-09"},"primaryCompletionDateStruct":{"date":"2011-03","type":"ACTUAL"},"completionDateStruct":{"date":"2011-03","type":"ACTUAL"},"studyFirstSubmitDate":"2006-07-31","studyFirstSubmitQcDate":"2006-07-31","studyFirstPostDateStruct":{"date":"2006-08-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-03-29","resultsFirstSubmitQcDate":"2013-02-11","resultsFirstPostDateStruct":{"date":"2013-03-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-08-17","lastUpdatePostDateStruct":{"date":"2015-09-15","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 study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["exenatide","diabetes","Amylin","Lilly","glimepiride"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1029,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"Glimepiride","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: glimepiride"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection (5mcg or 10mcg), twice a day","armGroupLabels":["Exenatide"],"otherNames":["Byetta"]},{"type":"DRUG","name":"glimepiride","description":"oral tablet (titrated to maximally tolerated dose), once daily","armGroupLabels":["Glimepiride"],"otherNames":["Amaryl"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Patients With Treatment Failure","description":"Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.","timeFrame":"Baseline to end of Period II (up to 4.5 years)"},{"measure":"Time to Treatment Failure","description":"Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.","timeFrame":"Baseline to end of Period II (up to 4.5 years)"}],"secondaryOutcomes":[{"measure":"Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3","description":"HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).","timeFrame":"Year 3 in Period II"},{"measure":"Change in HOMA-B From Baseline to Endpoint","description":"Change in HOMA-B from baseline to endpoint.","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Fasting Proinsulin/Insulin Ratio at Year 3","description":"Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.","description":"Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3","description":"DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).","timeFrame":"Year 3 in Period II"},{"measure":"Change in DI30/DG30 Ratio From Baseline to Endpoint","description":"Change in DI30/DG30 ratio from baseline to endpoint.","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Disposition Index at Year 3","description":"Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).","timeFrame":"Year 3 in Period II"},{"measure":"Change in Disposition Index From Baseline to Endpoint","description":"Change in disposition index from baseline to endpoint.","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Change in HbA1c From Baseline to Year 3","description":"Change in HbA1c from baseline to Year 3.","timeFrame":"Baseline, Year 3 in Period II"},{"measure":"Change in HbA1c From Baseline to Endpoint","description":"Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Fasting Plasma Glucose at Year 3","description":"Fasting plasma glucose at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Change in Fasting Plasma Glucose From Baseline to Endpoint","description":"Change in fasting plasma glucose from baseline to endpoint.","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Postprandial (2 Hours) Plasma Glucose at Year 3","description":"Postprandial (2 hours) plasma glucose at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint","description":"Change from baseline in postprandial (2 hours) plasma glucose to endpoint.","timeFrame":"Baseline, end of Period II (up to 4.5 years)"},{"measure":"Change in Body Weight From Baseline to Year 3","description":"Change in Body weight from baseline to Year 3.","timeFrame":"Baseline, Year 3 in Period II"},{"measure":"Systolic Blood Pressure at Year 3","description":"Systolic Blood pressure at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Diastolic Blood Pressure at Year 3","description":"Diastolic Blood pressure at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Heart Rate at Year 3","description":"Heart rate at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Triglycerides at Year 3","description":"Triglycerides at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Total Cholesterol at Year 3","description":"Total Cholesterol at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"High-density Lipoprotein (HDL) Cholesterol at Year 3","description":"HDL Cholesterol at Year 3.","timeFrame":"Year 3 in Period II"},{"measure":"Hypoglycemia Rate Per Year","description":"All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration \\<=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration \\<=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.","timeFrame":"Baseline to end of Period II (up to 4.5 years)"},{"measure":"Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III","description":"Change in HbA1c from baseline to Year 2.","timeFrame":"Baseline in Period III, Year 2 in Period III"},{"measure":"Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III","description":"Change in HbA1c from baseline to Year 2.","timeFrame":"Baseline in Period III, Year 2 in Period III"},{"measure":"Hypoglycemia Rate Per Year in Period III","description":"All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration \\<=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration \\<=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.","timeFrame":"Start of Period III to end of study"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus.\n* Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.\n* HbA1c \\>=6.5% and \\<=9.0%.\n* Body Mass Index (BMI) \\>=25 kg/m\\^2 and \\<40 kg/m\\^2.\n\nExclusion Criteria:\n\n* Participated in an interventional medical, surgical, or pharmaceutical study 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Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z."},{"pmid":"25846577","type":"DERIVED","citation":"Schernthaner G, Rosas-Guzman J, Dotta F, Guerci B, Simo R, Festa A, Kiljanski J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8."},{"pmid":"22683137","type":"DERIVED","citation":"Gallwitz B, Guzman J, Dotta F, Guerci B, Simo R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients meeting defined failure of HbA1c control (primary endpoint) in Study Period II were eligible for entry to Study Period III","groups":[{"id":"FG000","title":"Period II, Glim + Met","description":"Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin"},{"id":"FG001","title":"Period III, Exen + Met + Glim - Randomized","description":"Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III"},{"id":"FG002","title":"Period III, Exen + Met + Pio or Rosi - Randomized","description":"Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period 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With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if \\<1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. 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