Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-26 @ 10:26 PM
Study NCT ID:
NCT00360334
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2006-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
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'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks', 'otherNumAffected': 105, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol', 'otherNumAffected': 94, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bowel sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wrong drug administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.71', 'ciLowerLimit': '2.62', 'ciUpperLimit': '8.46', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Composite endpoint evaluating effect of treatment on glycemic control and weight', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.76', 'ciLowerLimit': '3.11', 'ciUpperLimit': '10.64', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Composite endpoint evaluating effect of treatment on glycemic control and weight', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.12', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-3.61', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Achieving HbA1c ≤ 7.4%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000'}, {'value': '61.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.280', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.26', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of patients achieving specified HbA1c target at endpoint', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Achieving HbA1c < 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.19', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of patients achieving specified HbA1c target at endpoint', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Achieving HbA1c < 6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.363', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.66', 'ciUpperLimit': '3.07', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of patients achieving specified HbA1c target at endpoint', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in 7 Point Self Monitored Blood Glucose Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Pre-breakfast: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '9.98', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Pre-breakfast: Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-2.01', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-3.99', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': '2 hrs after breakfast: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '13.53', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': '2 hrs after breakfast: Change at endpt (Week 26)', 'categories': [{'measurements': [{'value': '-5.09', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '-3.95', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'Pre-lunch: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '9.95', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '9.54', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': 'Pre-lunch: Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '-2.59', 'spread': '3.27', 'groupId': 'OG001'}]}]}, {'title': '2 hrs after lunch: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '12.07', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '11.15', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': '2 hrs after lunch: Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-3.20', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '-2.48', 'spread': '3.17', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dinner: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '9.95', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '9.37', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dinner: Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-2.13', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '4.76', 'groupId': 'OG001'}]}]}, {'title': '2 hrs after dinner: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '12.59', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '11.80', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': '2 hrs after dinner: Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-4.59', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '3.22', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime: Baseline (Week 0)', 'categories': [{'measurements': [{'value': '11.63', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '11.24', 'spread': '3.05', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime: Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-3.56', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '3.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks', 'description': 'Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '34.49', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '33.71', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in BMI from baseline to endpoint', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '112.07', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '110.64', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-2.19', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 Weeks', 'description': 'Change in waist circumference from baseline to endpoint', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Waist-to-hip Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in waist-to-hip ratio from baseline to endpoint', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '101.19', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '97.93', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-2.73', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in body weight from baseline to endpoint', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percent Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 Weeks', 'description': 'Percent change in baseline body weight at endpoint', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Achieving 5% Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '27.91', 'ciLowerLimit': '3.70', 'ciUpperLimit': '210.54', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of patients who lost at least 5% of baseline body weight at endpoint', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Achieving 10% Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of patients who lost at least 10% of baseline body weight at endpoint', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '134.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '134.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in systolic blood pressure from baseline to endpoint', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '79.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '79.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at endpoint (Week 26)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in diastolic blood pressure from baseline to endpoint', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in TC from baseline to endpoint', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Change in High Density Lipoprotein (HDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.471', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in HDL cholesterol from baseline to endpoint', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Change in TC to HDL Cholesterol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.601', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in TC to HDL cholesterol ratio from baseline to endpoint', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.650', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in fasting serum triglycerides from baseline to endpoint', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Change in Low Density Lipoprotein (LDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in LDL cholesterol from baseline to endpoint', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Change in Apolipoprotein-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.667', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in apolipoprotein-B from baseline to endpoint', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.675', 'ciLowerLimit': '0.401', 'ciUpperLimit': '1.136', 'groupDescription': 'Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Incidence of Nocturnal Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': 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Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Hypoglycemic Rate Per 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to 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'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.000'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.163'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA on ranks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '26 weeks', 'description': 'Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days', 'unitOfMeasure': 'Number of episodes per 30 days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycemic Rate Per 30 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'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Entry criterion not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted at 35 study centers in the United Kingdom. Recruitment occurred from June 2006 to October 2007.', 'preAssignmentDetails': 'One patient assigned to the Insulin Glargine group withdrew from the study prior to receiving study drug. This patient is not included in the analysis set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide', 'description': '5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'dosing based on treat to target protocol'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '56.5', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Types of oral antidiabetic medication combinations administered at baseline', 'classes': [{'title': 'metformin and sulfonylurea', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'metformin and thiazolidinedione', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'sulfonylurea and thiazolidinedione', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'metformin, sulfonylurea, and thiazolidinedione', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline apolipoprotein-B', 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'spread': '0.24', 'groupId': 'BG000'}, {'value': '0.88', 'spread': '0.24', 'groupId': 'BG001'}, {'value': '0.86', 'spread': '0.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline fasting serum glucose', 'classes': [{'categories': [{'measurements': [{'value': '10.84', 'spread': '2.23', 'groupId': 'BG000'}, {'value': '10.12', 'spread': '2.22', 'groupId': 'BG001'}, {'value': '10.48', 'spread': '2.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline fasting serum total cholesterol (TC)', 'classes': [{'categories': [{'measurements': [{'value': '4.45', 'spread': '1.05', 'groupId': 'BG000'}, {'value': '4.63', 'spread': '1.20', 'groupId': 'BG001'}, {'value': '4.54', 'spread': '1.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline fasting serum triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '2.31', 'spread': '2.24', 'groupId': 'BG001'}, {'value': '2.13', 'spread': '1.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline high density lipoprotein (HDL) cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.24', 'groupId': 'BG000'}, {'value': '1.15', 'spread': '0.29', 'groupId': 'BG001'}, {'value': '1.15', 'spread': '0.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline low density lipoprotein (LDL) cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '2.49', 'spread': '1.02', 'groupId': 'BG001'}, {'value': '2.43', 'spread': '0.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline total cholesterol to high density lipoprotein cholesterol ratio', 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '4.29', 'spread': '2.15', 'groupId': 'BG001'}, {'value': '4.15', 'spread': '1.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2006-08-02', 'resultsFirstSubmitDate': '2009-04-14', 'studyFirstSubmitQcDate': '2006-08-02', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-14', 'studyFirstPostDateStruct': {'date': '2006-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)', 'timeFrame': '26 weeks', 'description': 'Composite endpoint evaluating effect of treatment on glycemic control and weight'}], 'secondaryOutcomes': [{'measure': 'Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg', 'timeFrame': '26 weeks', 'description': 'Composite endpoint evaluating effect of treatment on glycemic control and weight'}, {'measure': 'Change in Fasting Serum Glucose', 'timeFrame': '26 weeks', 'description': 'Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)'}, {'measure': 'Percent of Patients Achieving HbA1c ≤ 7.4%', 'timeFrame': '26 weeks', 'description': 'Percent of patients achieving specified HbA1c target at endpoint'}, {'measure': 'Percent of Patients Achieving HbA1c < 7%', 'timeFrame': '26 weeks', 'description': 'Percent of patients achieving specified HbA1c target at endpoint'}, {'measure': 'Percent of Patients Achieving HbA1c < 6.5%', 'timeFrame': '26 weeks', 'description': 'Percent of patients achieving specified HbA1c target at endpoint'}, {'measure': 'Change in 7 Point Self Monitored Blood Glucose Profile', 'timeFrame': '26 weeks', 'description': 'Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': '26 weeks', 'description': 'Change in BMI from baseline to endpoint'}, {'measure': 'Change in Waist Circumference', 'timeFrame': '26 Weeks', 'description': 'Change in waist circumference from baseline to endpoint'}, {'measure': 'Change in Waist-to-hip Ratio', 'timeFrame': '26 weeks', 'description': 'Change in waist-to-hip ratio from baseline to endpoint'}, {'measure': 'Change in Body Weight', 'timeFrame': '26 weeks', 'description': 'Change in body weight from baseline to endpoint'}, {'measure': 'Percent Change in Body Weight', 'timeFrame': '26 Weeks', 'description': 'Percent change in baseline body weight at endpoint'}, {'measure': 'Percent of Patients Achieving 5% Weight Loss', 'timeFrame': '26 weeks', 'description': 'Percent of patients who lost at least 5% of baseline body weight at endpoint'}, {'measure': 'Percent of Patients Achieving 10% Weight Loss', 'timeFrame': '26 weeks', 'description': 'Percent of patients who lost at least 10% of baseline body weight at endpoint'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': '26 weeks', 'description': 'Change in systolic blood pressure from baseline to endpoint'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': '26 weeks', 'description': 'Change in diastolic blood pressure from baseline to endpoint'}, {'measure': 'Change in Fasting Serum Total Cholesterol (TC)', 'timeFrame': '26 weeks', 'description': 'Change in TC from baseline to endpoint'}, {'measure': 'Change in High Density Lipoprotein (HDL) Cholesterol', 'timeFrame': '26 weeks', 'description': 'Change in HDL cholesterol from baseline to endpoint'}, {'measure': 'Change in TC to HDL Cholesterol Ratio', 'timeFrame': '26 weeks', 'description': 'Change in TC to HDL cholesterol ratio from baseline to endpoint'}, {'measure': 'Change in Fasting Serum Triglycerides', 'timeFrame': '26 weeks', 'description': 'Change in fasting serum triglycerides from baseline to endpoint'}, {'measure': 'Change in Low Density Lipoprotein (LDL) Cholesterol', 'timeFrame': '26 weeks', 'description': 'Change in LDL cholesterol from baseline to endpoint'}, {'measure': 'Change in Apolipoprotein-B', 'timeFrame': '26 weeks', 'description': 'Change in apolipoprotein-B from baseline to endpoint'}, {'measure': 'Incidence of Hypoglycemic Episodes', 'timeFrame': '26 weeks', 'description': 'Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study'}, {'measure': 'Incidence of Nocturnal Hypoglycemic Episodes', 'timeFrame': '26 weeks', 'description': 'Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study'}, {'measure': 'Incidence of Severe Hypoglycemic Episodes', 'timeFrame': '26 weeks', 'description': 'Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study'}, {'measure': 'Hypoglycemic Rate Per 30 Days', 'timeFrame': '26 weeks', 'description': 'Number of hypoglycemic episodes per patient adjusted per 30 days'}, {'measure': 'Nocturnal Hypoglycemic Rate Per 30 Days', 'timeFrame': '26 weeks', 'description': 'Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days'}, {'measure': 'Severe Hypoglycemic Rate Per 30 Days', 'timeFrame': '26 weeks', 'description': 'Number of severe hypoglycemic episodes per patient adjusted per 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'insulin glargine', 'Lilly', 'Amylin'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19930005', 'type': 'RESULT', 'citation': 'Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.'}, {'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 is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.\n* HbA1c between 7.5% and 10.0%.\n* BMI \\>27.\n\nExclusion Criteria:\n\n* Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.\n* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.\n* Treatment with the following medications: \\*Insulin as outpatient therapy within last 3 months; \\*Meglitinides, or acarbose within the last 3 months; \\*Regular use of any drugs that directly affect gastrointestinal motility; \\*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \\*Anti-obesity agent use within the last 3 months.\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': 'NCT00360334', 'briefTitle': 'A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 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