Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 9:33 AM
Study NCT ID:
NCT00375492
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2006-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect on Weight Loss of Exenatide Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks', 'otherNumAffected': 87, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks', 'otherNumAffected': 82, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.16', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-3.97', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0030', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.', 'unitOfMeasure': 'percent hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'title': 'Morning Pre-Meal', 'categories': [{'measurements': [{'value': '-1.87', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '2 Hours Post Morning Meal', 'categories': [{'measurements': [{'value': '-2.67', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Midday Pre-Meal', 'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': '2 Hours Post Midday Meal', 'categories': [{'measurements': [{'value': '-2.12', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Evening Pre-Meal', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': '2 Hours Post Evening Meal', 'categories': [{'measurements': [{'value': '-3.09', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.33', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-4.18', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1985', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1827', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1584', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8279', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8334', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2881', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, week 24', 'description': 'Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Ratio of Triglycerides at Week 24 to Triglycerides at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0654', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'baseline, Week 24', 'description': 'Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hypoglycemic Events During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.728', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Number of participants experiencing one or more events of hypoglycemia at any point in the study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Rate of Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'OG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.14', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '4.58', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.127', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).', 'unitOfMeasure': 'events per patient per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'FG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Loss of Glucose Control', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'One randomized patient per group discontinued before receiving study drug. These patients are not included in the "started" category below.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (Exenatide)', 'description': 'exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks'}, {'id': 'BG001', 'title': 'Group B (Placebo)', 'description': 'placebo (volume equivalent to exenatide injection) twice daily for 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.52', 'spread': '10.02', 'groupId': 'BG000'}, {'value': '55.08', 'spread': '8.97', 'groupId': 'BG001'}, {'value': '54.81', 'spread': '9.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '94.90', 'spread': '16.52', 'groupId': 'BG000'}, {'value': '96.16', 'spread': '16.53', 'groupId': 'BG001'}, {'value': '95.53', 'spread': '16.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '4.67', 'spread': '1.03', 'groupId': 'BG000'}, {'value': '4.68', 'spread': '0.90', 'groupId': 'BG001'}, {'value': '4.68', 'spread': '0.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Glycosylated Hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.74', 'spread': '0.87', 'groupId': 'BG000'}, {'value': '7.51', 'spread': '0.82', 'groupId': 'BG001'}, {'value': '7.62', 'spread': '0.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline High Density Lipoprotein (HDL) Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0.32', 'groupId': 'BG000'}, {'value': '1.21', 'spread': '0.31', 'groupId': 'BG001'}, {'value': '1.20', 'spread': '0.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Homeostatic Model Assessment-Beta Cell (HOMA-B)', 'classes': [{'categories': [{'measurements': [{'value': '75.15', 'spread': '81.20', 'groupId': 'BG000'}, {'value': '70.72', 'spread': '53.16', 'groupId': 'BG001'}, {'value': '72.81', 'spread': '67.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent beta-cell function', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)', 'classes': [{'categories': [{'measurements': [{'value': '49.72', 'spread': '32.12', 'groupId': 'BG000'}, {'value': '62.90', 'spread': '41.07', 'groupId': 'BG001'}, {'value': '56.68', 'spread': '37.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent insulin sensitivity', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Low Density Lipoprotein (LDL) Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '2.74', 'spread': '0.88', 'groupId': 'BG000'}, {'value': '2.78', 'spread': '0.82', 'groupId': 'BG001'}, {'value': '2.76', 'spread': '0.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '2.15', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '2.13', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '2.14', 'spread': '0.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '109.64', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '108.85', 'spread': '12.10', 'groupId': 'BG001'}, {'value': '109.24', 'spread': '11.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2006-09-11', 'resultsFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2006-09-11', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-30', 'studyFirstPostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 24', 'description': 'Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24', 'timeFrame': 'baseline, Week 24', 'description': 'Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.'}, {'measure': 'Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24', 'timeFrame': 'baseline, Week 24', 'description': 'Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).'}, {'measure': 'Change From Baseline in Waist Circumference at Week 24', 'timeFrame': 'baseline, Week 24', 'description': 'Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).'}, {'measure': 'Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline', 'timeFrame': 'baseline, Week 24', 'description': 'Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.'}, {'measure': 'Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline', 'timeFrame': 'baseline, Week 24', 'description': 'Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.'}, {'measure': 'Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24', 'timeFrame': 'baseline, Week 24', 'description': 'Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.'}, {'measure': 'Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24', 'timeFrame': 'baseline, Week 24', 'description': 'Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L'}, {'measure': 'Change From Baseline in Total Cholesterol at Week 24', 'timeFrame': 'baseline, week 24', 'description': 'Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.'}, {'measure': 'Ratio of Triglycerides at Week 24 to Triglycerides at Baseline', 'timeFrame': 'baseline, Week 24', 'description': 'Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.'}, {'measure': 'Number of Participants With Hypoglycemic Events During the Study', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Number of participants experiencing one or more events of hypoglycemia at any point in the study'}, {'measure': 'Rate of Hypoglycemic Events', 'timeFrame': '24 weeks', 'description': 'Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'overweight', 'obesity', 'weight loss', 'exenatide', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22913891', 'type': 'DERIVED', 'citation': 'Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes for at least 6 months\n* Have been treated with a stable dose of the following for at least 6 weeks prior to screening: \\*immediate or extended release metformin, or \\*a sulfonylurea, or \\*a fixed-dose sulfonylurea/metformin combination therapy\n* Have an HbA1c of 6.6% to 10.0%, inclusive\n* Have a Body Mass Index (BMI) of 25 kg/m\\^2 to 39.9 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\n* Are treated with any of the following excluded medications: \\*exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; \\*Symlin injection at any time; \\* Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; \\*drugs that directly affect gastrointestinal motility; \\*use of a weight loss drug (including those available over the counter) within 3 months of screening; \\*chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening\n* Have conditions contraindicating metformin and/or sulfonylurea use\n* Have had a change in lipid-lowering agents within 6 weeks of screening\n* Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study\n* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry'}, 'identificationModule': {'nctId': 'NCT00375492', 'briefTitle': 'Effect on Weight Loss of Exenatide Versus Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program', 'orgStudyIdInfo': {'id': 'H8O-US-GWBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Drug: exenatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'subcutaneous injection, 5mcg or 10mcg, twice a day', 'armGroupLabels': ['Group A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'subcutaneous injection, volume equivalent to exenatide dose, twice a day', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'James Malone, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}