{"protocolSection":{"identificationModule":{"nctId":"NCT00676338","orgStudyIdInfo":{"id":"H8O-MC-GWCH (DURATION - 4)"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)","officialTitle":"Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-11"},"primaryCompletionDateStruct":{"date":"2010-07","type":"ACTUAL"},"completionDateStruct":{"date":"2011-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-05-09","studyFirstSubmitQcDate":"2008-05-09","studyFirstPostDateStruct":{"date":"2008-05-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-14","resultsFirstSubmitQcDate":"2012-10-24","resultsFirstPostDateStruct":{"date":"2012-11-26","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-06-15","dispFirstSubmitQcDate":"2011-06-17","dispFirstPostDateStruct":{"date":"2011-06-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-20","lastUpdatePostDateStruct":{"date":"2015-04-09","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 will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["Amylin","Lilly","exenatide once weekly","Byetta","Januvia","sitagliptin","thiazolidinedione"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":820,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Once Weekly","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide once weekly"]},{"label":"Metformin","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: metformin"]},{"label":"Sitagliptin","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: sitagliptin"]},{"label":"Pioglitazone","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: pioglitazone"]}],"interventions":[{"type":"DRUG","name":"exenatide once weekly","description":"subcutaneous injection, 2mg, once weekly plus placebo oral once daily","armGroupLabels":["Exenatide Once Weekly"]},{"type":"DRUG","name":"metformin","description":"oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection","armGroupLabels":["Metformin"]},{"type":"DRUG","name":"sitagliptin","description":"oral, 100 mg, daily plus placebo once weekly subcutaneous injection","armGroupLabels":["Sitagliptin"]},{"type":"DRUG","name":"pioglitazone","description":"oral, 30-45mg, daily plus placebo once weekly subcutaneous injection","armGroupLabels":["Pioglitazone"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Week 26","description":"Change in HbA1c from baseline to Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Patients Achieving HbA1c <=7% at Week 26","description":"Percentage of patients achieving HbA1c \\<=7% at Week 26 (for patients with baseline HbA1c \\>7%).","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Change in Fasting Serum Glucose (FSG) From Baseline to Week 26","description":"Change in FSG from baseline to Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Body Weight From Baseline to Week 26","description":"Change in Body Weight from baseline to Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Fasting Total Cholesterol (TC) From Baseline to Week 26","description":"Change in Fasting TC from baseline to Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26","description":"Change in Fasting HDL from baseline to Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Ratio of Fasting Triglycerides at Week 26 to Baseline","description":"Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.","timeFrame":"Baseline, Week 26"},{"measure":"Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events","description":"Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\\*\\*2).","timeFrame":"Baseline to Week 26"},{"measure":"Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events","description":"Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\\*\\*2).","timeFrame":"Baseline to Week 26"},{"measure":"Change in Systolic Blood Pressure From Baseline to Week 26.","description":"Change in Systolic Blood Pressure from baseline to Week 26.","timeFrame":"Baseline, Week 26"},{"measure":"Change in Diastolic Blood Pressure From Baseline to Week 26.","description":"Change in Diastolic Blood Pressure from baseline to Week 26.","timeFrame":"Baseline, Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* have type 2 diabetes and are treated with diet and exercise alone.\n* at least 18 years of age.\n* HbA1c between 7.1% and 11.0%, inclusive.\n* Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.\n* Have a history of stable body weight (not varying by \\>5% for at least 3 months prior to screening).\n\nExclusion Criteria:\n\n* Have history of cardiac disease or presence of active cardiac disease within the year prior to 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Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18."},{"pmid":"23748507","type":"DERIVED","citation":"Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661."},{"pmid":"23748506","type":"DERIVED","citation":"Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660."},{"pmid":"23522121","type":"DERIVED","citation":"Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48."},{"pmid":"22210563","type":"DERIVED","citation":"Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzalez JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo"},{"id":"FG001","title":"Metformin","description":"Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"FG002","title":"Pioglitazone","description":"Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"FG003","title":"Sitagliptin","description":"Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection"}],"periods":[{"title":"Overall 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H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","pValue":"0.328","pValueComment":"Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). 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H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","pValue":"<.001","pValueComment":"Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.37","ciPctValue":"98.3","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"-0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.10"}]},{"type":"PRIMARY","title":"Percentage of Patients Achieving HbA1c <=7% at Week 26","description":"Percentage of patients achieving HbA1c \\<=7% at Week 26 (for patients with baseline HbA1c \\>7%).","populationDescription":"ITT subjects with baseline HbA1c\\>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo"},{"id":"OG001","title":"Metformin","description":"Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG002","title":"Pioglitazone","description":"Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG003","title":"Sitagliptin","description":"Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"150"},{"groupId":"OG003","value":"143"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64.2"},{"groupId":"OG001","value":"57.3"},{"groupId":"OG002","value":"63.3"},{"groupId":"OG003","value":"45.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.151","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Fisher Exact","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.913","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Fisher Exact","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Fisher Exact","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Fasting Serum Glucose (FSG) From Baseline to Week 26","description":"Change in FSG from baseline to Week 26.","populationDescription":"ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo"},{"id":"OG001","title":"Metformin","description":"Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG002","title":"Pioglitazone","description":"Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG003","title":"Sitagliptin","description":"Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"203"},{"groupId":"OG002","value":"127"},{"groupId":"OG003","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.25","spread":"0.14"},{"groupId":"OG001","value":"-1.98","spread":"0.14"},{"groupId":"OG002","value":"-2.57","spread":"0.18"},{"groupId":"OG003","value":"-1.13","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.155","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.66","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.19"},{"groupIds":["OG000","OG002"],"groupDescription":"Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.153","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.12","ciUpperLimit":"0.75","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.22"},{"groupIds":["OG000","OG003"],"groupDescription":"Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.56","ciUpperLimit":"-0.68","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.22"}]},{"type":"SECONDARY","title":"Change in Body Weight From Baseline to Week 26","description":"Change in Body Weight from baseline to Week 26.","populationDescription":"ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo"},{"id":"OG001","title":"Metformin","description":"Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG002","title":"Pioglitazone","description":"Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG003","title":"Sitagliptin","description":"Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"217"},{"groupId":"OG002","value":"134"},{"groupId":"OG003","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.04","spread":"0.21"},{"groupId":"OG001","value":"-2.00","spread":"0.21"},{"groupId":"OG002","value":"1.52","spread":"0.26"},{"groupId":"OG003","value":"-0.76","spread":"0.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.892","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.61","ciUpperLimit":"0.53","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.29"},{"groupIds":["OG000","OG002"],"groupDescription":"Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-3.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.21","ciUpperLimit":"-2.90","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.33"},{"groupIds":["OG000","OG003"],"groupDescription":"Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.92","ciUpperLimit":"-0.63","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.33"}]},{"type":"SECONDARY","title":"Change in Fasting Total Cholesterol (TC) From Baseline to Week 26","description":"Change in Fasting TC from baseline to Week 26.","populationDescription":"ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo"},{"id":"OG001","title":"Metformin","description":"Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG002","title":"Pioglitazone","description":"Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG003","title":"Sitagliptin","description":"Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"203"},{"groupId":"OG002","value":"127"},{"groupId":"OG003","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.24","spread":"0.06"},{"groupId":"OG001","value":"-0.22","spread":"0.06"},{"groupId":"OG002","value":"0.09","spread":"0.08"},{"groupId":"OG003","value":"-0.01","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.873","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.08"},{"groupIds":["OG000","OG002"],"groupDescription":"Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.52","ciUpperLimit":"-0.14","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.10"},{"groupIds":["OG000","OG003"],"groupDescription":"Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.022","pValueComment":"No multiple adjustment were done.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.41","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.10"}]},{"type":"SECONDARY","title":"Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26","description":"Change in Fasting HDL from baseline to Week 26.","populationDescription":"ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. 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Missing data at endpoint was imputed using LOCF approach.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Exenatide Once Weekly","description":"Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo"},{"id":"OG001","title":"Metformin","description":"Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG002","title":"Pioglitazone","description":"Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection"},{"id":"OG003","title":"Sitagliptin","description":"Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"127"},{"groupId":"OG003","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"0.03"},{"groupId":"OG001","value":"0.96","spread":"0.03"},{"groupId":"OG002","value":"0.85","spread":"0.03"},{"groupId":"OG003","value":"0.94","spread":"0.04"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.657","pValueComment":"No multiple adjustment were done.","statisticalMethod":"ANCOVA","paramType":"Geometric Least Squares Mean Ratio","paramValue":"1.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.94","ciUpperLimit":"1.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04"},{"groupIds":["OG000","OG002"],"groupDescription":"Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"No multiple adjustment were done.","statisticalMethod":"ANCOVA","paramType":"Geometric Least Squares Mean Ratio","paramValue":"1.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.06","ciUpperLimit":"1.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05"},{"groupIds":["OG000","OG003"],"groupDescription":"Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.398","pValueComment":"No multiple adjustment were done.","statisticalMethod":"ANCOVA","paramType":"Geometric Least Squares Mean Ratio","paramValue":"1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"1.14","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05"}]},{"type":"SECONDARY","title":"Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events","description":"Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. 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Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. 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Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. 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