{"protocolSection":{"identificationModule":{"nctId":"NCT00658021","orgStudyIdInfo":{"id":"D5550C00002"},"secondaryIdInfos":[{"id":"H8O-MC-GWBQ","type":"OTHER","domain":"company identifier"}],"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes","officialTitle":"Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes."},"statusModule":{"statusVerifiedDate":"2020-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-05-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-04-18","type":"ACTUAL"},"completionDateStruct":{"date":"2020-04-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-04-08","studyFirstSubmitQcDate":"2008-04-08","studyFirstPostDateStruct":{"date":"2008-04-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-09-23","resultsFirstSubmitQcDate":"2020-11-06","resultsFirstPostDateStruct":{"date":"2020-12-01","type":"ACTUAL"},"dispFirstSubmitDate":"2020-01-14","dispFirstSubmitQcDate":"2020-01-14","dispFirstPostDateStruct":{"date":"2020-01-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-11-06","lastUpdatePostDateStruct":{"date":"2020-12-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Quintiles, Inc.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU"},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["diabetes","adolescents","exenatide","Astra Zeneca"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":122,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Subcutaneous injection, twice a day","interventionNames":["Drug: Placebo"]},{"label":"Exenatide 5 µg","type":"EXPERIMENTAL","description":"Subcutaneous injection, twice a day","interventionNames":["Drug: Exenatide"]},{"label":"Exenatide 10 µg","type":"EXPERIMENTAL","description":"Subcutaneous injection, twice a day","interventionNames":["Drug: Exenatide"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Subcutaneous injection, twice a day","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Exenatide","description":"Subcutaneous injection, 5 µg, twice a day","armGroupLabels":["Exenatide 5 µg"]},{"type":"DRUG","name":"Exenatide","description":"Subcutaneous injection,10 µg, twice a day","armGroupLabels":["Exenatide 10 µg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28","description":"Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","timeFrame":"Baseline (Day 1) and Week 28"},{"measure":"Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period","description":"Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).","timeFrame":"From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit."}],"secondaryOutcomes":[{"measure":"Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28","description":"The percentage of participants achieving HbA1c goals of \\< 7%, \\<= 6.5%, and \\< 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder.","timeFrame":"Weeks 0, 4, 12, 20 and 28"},{"measure":"Adjusted Change From Baseline in Body Weight Through Week 28","description":"Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","timeFrame":"Baseline (Day 1) up to Week 28"},{"measure":"Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28","description":"Change from baseline in FSG is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An analysis of covariance (ANCOVA) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","timeFrame":"Baseline (Day 1) and Week 28"},{"measure":"Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28","description":"Change from baseline in SMBG measurements are reported as adjusted LS mean values at Week 28. SMBG measurements were taken before (pre-prandial) and 2 hours after (post-prandial) the 2 main meals of the day on 3 separate days during the week before baseline (Day 1) and Week 28. Post-prandial excursions were calculated as the difference between the pre-prandial and post-prandial blood glucose concentrations (post-prandial - pre-prandial) and averaged (mean) over the 2 main meals over the 3 separate days in each period. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","timeFrame":"Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28"},{"measure":"Adjusted Change From Baseline in Fasting Serum Insulin at Week 28","description":"Change from baseline in fasting serum insulin is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","timeFrame":"Baseline (Day 1) and Week 28"},{"measure":"Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28","description":"Change from baseline in HOMA-B and HOMA-S are reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","timeFrame":"Baseline (Day 1) and Week 28"},{"measure":"Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28","description":"Participants were discontinued from the study due to failure to maintain glycemic control if either discontinuation reason on summary case report form was \"Loss of glucose control\" or AE with lower level Medical Dictionary for Regulatory Activities (MedDRA) term \"Loss of control of blood sugar\" or \"Hyperglycaemia\" leading to study drug discontinuation, using MedDRA Version 23.0.","timeFrame":"Weeks 2, 4, 8, 12, 16, 20, 24 and 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria:\n\n* are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm\n* have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria\n* have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit\n* have fasting C-peptide \\>0.6 ng/mL\n* have HbA1c between 6.5% and 10.5%, inclusive.\n\nDisease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:\n\n* diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history\n* fasting blood glucose 126 mg/dL (7.0 mmol/L)\n* random blood glucose 200 mg/dL (11.1 mmol/L)\n* two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).\n\nExclusion Criteria-patients will be excluded from the study if they meet any of the following criteria:\n\n* have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide\n* are unwilling or unable to inject the study medication\n* currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily\n* have used oral steroids within the last 60 days or more than 20 days use within the past year\n* have used any weight loss medication(s) within 30 days of screening\n* have used insulin for more than 10 weeks during the 3 months prior to screening\n* have history of renal disease, or serum creatinine \\>1.6 mg/dL (141.4 µmol/L) (males) or \\>1.4 mg/dL (123.8 µmol/L) (females)\n* have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase \\>3.0 times the upper limit of normal (ULN).","healthyVolunteers":false,"sex":"ALL","minimumAge":"10 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"locations":[{"facility":"Research 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All requests will be evaluated as per the AZ disclosure commitment.\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","infoTypes":["STUDY_PROTOCOL","SAP"],"timeFrame":"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","accessCriteria":"When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","url":"https://astrazenecagroup-dt.pharmacm.com/DT/Home"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study commenced with a 1-week, single-blind, injectable placebo lead-in period before participants were randomized to 1 of 3 treatment groups: exenatide 5 microgram (mcg) twice daily, exenatide 10 mcg twice daily, or placebo twice daily. A total of 122 participants were randomized in this study.","recruitmentDetails":"This study was conducted in adolescents (aged 10 to 17 years inclusive) with type 2 diabetes who were naïve to antidiabetics, or were receiving metformin, an sulfonylurea (SU) or a combination of metformin and an SU in 7 countries (Brazil, India, South Korea, Mexico, Russia, the United States and South Africa) between 30 May 2008 and 01 April 2020.","groups":[{"id":"FG000","title":"Exenatide 5 mcg","description":"Adolescent participants received exenatide 5 mcg subcutaneous (SC) injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 millimeter (mm) between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"FG001","title":"Exenatide 10 mcg","description":"Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"FG002","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"periods":[{"title":"28-Week Treatment Period","milestones":[{"type":"STARTED","comment":"Randomized to treatment.","achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"38"},{"groupId":"FG002","numSubjects":"42"}]},{"type":"Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"38"},{"groupId":"FG002","numSubjects":"42"}]},{"type":"COMPLETED","comment":"Completed the Week 28 treatment period.","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"25"},{"groupId":"FG002","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"17"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Developed study withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal by parent/guardian","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Loss of glucose control","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"10"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Did not receive treatment","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Long-term Safety Follow-up Period","milestones":[{"type":"STARTED","comment":"Entered safety follow-up period.","achievements":[{"groupId":"FG000","comment":"Entered safety follow-up period.","numSubjects":"7"},{"groupId":"FG001","comment":"Entered safety follow-up period.","numSubjects":"5"},{"groupId":"FG002","comment":"Entered safety follow-up period.","numSubjects":"7"}]},{"type":"COMPLETED","comment":"Completed safety follow-up period.","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The Intent-To-Treat analysis set included all randomized participants.","groups":[{"id":"BG000","title":"Exenatide 5 mcg","description":"Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"BG001","title":"Exenatide 10 mcg","description":"Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"BG002","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"42"},{"groupId":"BG003","value":"122"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13.7","spread":"1.94"},{"groupId":"BG001","value":"14.0","spread":"1.95"},{"groupId":"BG002","value":"14.4","spread":"1.82"},{"groupId":"BG003","value":"14.0","spread":"1.91"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"82"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"40"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Ethnicity not collected and Hispanic was collected as a Race in this study.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"25"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"29"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"10"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Hispanic","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"57"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28","description":"Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","populationDescription":"The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage (%HbA1c)","timeFrame":"Baseline (Day 1) and Week 28","groups":[{"id":"OG000","title":"Total Exenatide Twice Daily (EBID)","description":"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.\n\nAdolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks."},{"id":"OG001","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"0.215"},{"groupId":"OG001","value":"0.38","spread":"0.293"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.","nonInferiorityType":"SUPERIORITY","pValue":"0.444","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.01","ciUpperLimit":"0.45","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.363"}]},{"type":"PRIMARY","title":"Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period","description":"Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).","populationDescription":"The Safety Follow-up Analysis Set included all participants who had at least 1 safety follow-up period assessment visit.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.","groups":[{"id":"OG000","title":"Exenatide 5 mcg","description":"Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"OG001","title":"Exenatide 10 mcg","description":"Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."},{"id":"OG002","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28","description":"The percentage of participants achieving HbA1c goals of \\< 7%, \\<= 6.5%, and \\< 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder.","populationDescription":"The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"percentage of participants","timeFrame":"Weeks 0, 4, 12, 20 and 28","groups":[{"id":"OG000","title":"Total Exenatide Twice Daily (EBID)","description":"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.\n\nAdolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks."},{"id":"OG001","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"42"}]}],"classes":[{"title":"HbA1c < 7%: Week 0","categories":[{"measurements":[{"groupId":"OG000","value":"37.2","lowerLimit":"26.5","upperLimit":"47.9"},{"groupId":"OG001","value":"38.1","lowerLimit":"23.4","upperLimit":"52.8"}]}]},{"title":"HbA1c < 7%: Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"44.9","lowerLimit":"33.8","upperLimit":"55.9"},{"groupId":"OG001","value":"42.9","lowerLimit":"27.9","upperLimit":"57.8"}]}]},{"title":"HbA1c < 7%: Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"43.6","lowerLimit":"32.6","upperLimit":"54.6"},{"groupId":"OG001","value":"33.3","lowerLimit":"19.1","upperLimit":"47.6"}]}]},{"title":"HbA1c < 7%: Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"35.9","lowerLimit":"25.3","upperLimit":"46.5"},{"groupId":"OG001","value":"35.7","lowerLimit":"21.2","upperLimit":"50.2"}]}]},{"title":"HbA1c < 7%: Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"33.3","lowerLimit":"22.9","upperLimit":"43.8"},{"groupId":"OG001","value":"28.6","lowerLimit":"14.9","upperLimit":"42.2"}]}]},{"title":"HbA1c <=6.5%: Week 0","categories":[{"measurements":[{"groupId":"OG000","value":"17.9","lowerLimit":"9.4","upperLimit":"26.5"},{"groupId":"OG001","value":"16.7","lowerLimit":"5.4","upperLimit":"27.9"}]}]},{"title":"HbA1c <=6.5%: Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"29.5","lowerLimit":"19.4","upperLimit":"39.6"},{"groupId":"OG001","value":"23.8","lowerLimit":"10.9","upperLimit":"36.7"}]}]},{"title":"HbA1c <=6.5%: Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"33.3","lowerLimit":"22.9","upperLimit":"43.8"},{"groupId":"OG001","value":"23.8","lowerLimit":"10.9","upperLimit":"36.7"}]}]},{"title":"HbA1c <=6.5%: Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"24.4","lowerLimit":"14.8","upperLimit":"33.9"},{"groupId":"OG001","value":"19.0","lowerLimit":"7.2","upperLimit":"30.9"}]}]},{"title":"HbA1c <=6.5%: Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"23.1","lowerLimit":"13.7","upperLimit":"32.4"},{"groupId":"OG001","value":"19.0","lowerLimit":"7.2","upperLimit":"30.9"}]}]},{"title":"HbA1c <6.5%: Week 0","categories":[{"measurements":[{"groupId":"OG000","value":"15.4","lowerLimit":"7.4","upperLimit":"23.4"},{"groupId":"OG001","value":"7.1","lowerLimit":"0.0","upperLimit":"14.9"}]}]},{"title":"HbA1c <6.5%: Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"26.9","lowerLimit":"17.1","upperLimit":"36.8"},{"groupId":"OG001","value":"21.4","lowerLimit":"9.0","upperLimit":"33.8"}]}]},{"title":"HbA1c <6.5%: Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"30.8","lowerLimit":"20.5","upperLimit":"41.0"},{"groupId":"OG001","value":"19.0","lowerLimit":"7.2","upperLimit":"30.9"}]}]},{"title":"HbA1c <6.5%: Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"21.8","lowerLimit":"12.6","upperLimit":"31.0"},{"groupId":"OG001","value":"19.0","lowerLimit":"7.2","upperLimit":"30.9"}]}]},{"title":"HbA1c <6.5%: Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"23.1","lowerLimit":"13.7","upperLimit":"32.4"},{"groupId":"OG001","value":"14.3","lowerLimit":"3.7","upperLimit":"24.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in HbA1c \\< 7% at Week 28:\n\nTreatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.","nonInferiorityType":"SUPERIORITY","pValue":"0.562","statisticalMethod":"Cochran-Mantel-Haenszel"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in HbA1c \\<= 6.5% at Week 28:\n\nTreatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.","nonInferiorityType":"SUPERIORITY","pValue":"0.621","statisticalMethod":"Cochran-Mantel-Haenszel"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in HbA1c \\< 6.5% at Week 28:\n\nTreatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.","nonInferiorityType":"SUPERIORITY","pValue":"0.229","statisticalMethod":"Cochran-Mantel-Haenszel"}]},{"type":"SECONDARY","title":"Adjusted Change From Baseline in Body Weight Through Week 28","description":"Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","populationDescription":"The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram","timeFrame":"Baseline (Day 1) up to Week 28","groups":[{"id":"OG000","title":"Total Exenatide Twice Daily (EBID)","description":"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.\n\nAdolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks."},{"id":"OG001","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"42"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.89","spread":"0.196"},{"groupId":"OG001","value":"0.04","spread":"0.260"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-1.09","spread":"0.401"},{"groupId":"OG001","value":"-0.42","spread":"0.534"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-0.71","spread":"0.559"},{"groupId":"OG001","value":"-0.33","spread":"0.755"}]}]},{"title":"Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"-0.81","spread":"0.632"},{"groupId":"OG001","value":"-0.36","spread":"0.857"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in body weight at Week 4:\n\nAdjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.","nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.58","ciUpperLimit":"-0.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.327"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in body weight at Week 12:\n\nAdjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.","nonInferiorityType":"SUPERIORITY","pValue":"0.314","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.00","ciUpperLimit":"0.65","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.669"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in body weight at Week 20:\n\nAdjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.","nonInferiorityType":"SUPERIORITY","pValue":"0.692","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.37","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.24","ciUpperLimit":"1.50","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.940"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference in body weight at Week 28:\n\nAdjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.","nonInferiorityType":"SUPERIORITY","pValue":"0.679","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.56","ciUpperLimit":"1.68","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.065"}]},{"type":"SECONDARY","title":"Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28","description":"Change from baseline in FSG is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An analysis of covariance (ANCOVA) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","populationDescription":"The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline (Day 1) and Week 28","groups":[{"id":"OG000","title":"Total Exenatide Twice Daily (EBID)","description":"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.\n\nAdolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks."},{"id":"OG001","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.791","spread":"0.4010"},{"groupId":"OG001","value":"1.072","spread":"0.5466"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.679","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.281","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.614","ciUpperLimit":"1.052","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.6800"}]},{"type":"SECONDARY","title":"Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28","description":"Change from baseline in SMBG measurements are reported as adjusted LS mean values at Week 28. SMBG measurements were taken before (pre-prandial) and 2 hours after (post-prandial) the 2 main meals of the day on 3 separate days during the week before baseline (Day 1) and Week 28. Post-prandial excursions were calculated as the difference between the pre-prandial and post-prandial blood glucose concentrations (post-prandial - pre-prandial) and averaged (mean) over the 2 main meals over the 3 separate days in each period. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","populationDescription":"The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28","groups":[{"id":"OG000","title":"Total Exenatide Twice Daily (EBID)","description":"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.\n\nAdolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks."},{"id":"OG001","title":"Placebo","description":"Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"42"}]}],"classes":[{"title":"Pre-meal SMBG","categories":[{"measurements":[{"groupId":"OG000","value":"-0.699","spread":"0.2709"},{"groupId":"OG001","value":"-0.888","spread":"0.4511"}]}]},{"title":"Post-meal SMBG","categories":[{"measurements":[{"groupId":"OG000","value":"-1.029","spread":"0.2722"},{"groupId":"OG001","value":"-1.542","spread":"0.4503"}]}]},{"title":"Post-prandial excursion SMBG","categories":[{"measurements":[{"groupId":"OG000","value":"-0.181","spread":"0.2107"},{"groupId":"OG001","value":"-0.391","spread":"0.3418"}]}]},{"title":"Overall SMBG","categories":[{"measurements":[{"groupId":"OG000","value":"-0.877","spread":"0.2468"},{"groupId":"OG001","value":"-1.193","spread":"0.4117"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.714","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.189","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.821","ciUpperLimit":"1.199","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.5151"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.329","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.513","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.516","ciUpperLimit":"1.541","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.5245"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.601","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.210","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.577","ciUpperLimit":"0.997","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.4015"},{"groupIds":["OG000","OG001"],"groupDescription":"Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.505","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.316","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.615","ciUpperLimit":"1.248","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.4749"}]},{"type":"SECONDARY","title":"Adjusted Change From Baseline in Fasting Serum Insulin at Week 28","description":"Change from baseline in fasting serum insulin is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.","populationDescription":"The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomoles per liter","timeFrame":"Baseline (Day 1) and Week 28","groups":[{"id":"OG000","title":"Total Exenatide Twice Daily (EBID)","description":"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.\n\nAdolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. 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