Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
Study NCT ID:
NCT00960661
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2009-08-17
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], '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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.', 'eventGroups': [{'id': 'EG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)', 'otherNumAtRisk': 315, 'otherNumAffected': 228, 'seriousNumAtRisk': 315, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)', 'otherNumAtRisk': 312, 'otherNumAffected': 175, 'seriousNumAtRisk': 312, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 16}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 20}], 'organSystem': 'Infections and infestations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 11}], 'organSystem': 'Nervous system disorders'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 6}], 'organSystem': 'Vascular disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Ureteroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Carotid artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Arterial bypass operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '1.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '0.051', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6273', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.11', 'pValueComment': 'The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.', 'groupDescription': 'The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 30 weeks', 'description': 'Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).', 'unitOfMeasure': 'percent of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HbA1C < 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 30', 'description': 'Percentage of participants achieving HbA1C \\< 7.0%', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving HbA1c ≤ 6.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 30', 'description': 'Percent of participants achieving HbA1c ≤ 6.5%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.155', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.150', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 30', 'description': "Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in High Density Lipoprotein (HDL) From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.012', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 30', 'description': "Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in Low Density Lipoprotein (LDL) From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.042', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': "Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline to Week 30.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.45', 'spread': '0.255', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.247', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, week 30', 'description': 'Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.13', 'spread': '0.952', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.919', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.594', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.572', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 30', 'description': 'Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).'}, {'type': 'SECONDARY', 'title': 'Daily Insulin Glargine Dose at Baseline and at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.5', 'spread': '30.94', 'groupId': 'OG000'}, {'value': '61.1', 'spread': '35.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '56.9', 'spread': '29.35', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '31.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 30', 'description': 'Daily Insulin Glargine Dose at baseline and at Week 30', 'unitOfMeasure': 'IU/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively).'}, {'type': 'SECONDARY', 'title': 'Major Hypoglycemia Rate Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.23', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.1', 'spread': '0.39', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 weeks', 'description': 'Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.', 'unitOfMeasure': 'rate per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The As-treated population includes all randomized participants who had taken at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Minor Hypoglycemia Rate Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'OG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '5.08', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '2.07'}, {'value': '5.0', 'spread': '12.83', 'groupId': 'OG001', 'lowerLimit': '3.26', 'upperLimit': '4.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 weeks', 'description': 'Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL)', 'unitOfMeasure': 'rate per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The As-treated population includes all randomized participants who had taken at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled', 'description': 'Patients who enrolled in the basal insulin optimization (BIO) phase'}, {'id': 'FG001', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'FG002', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}], 'periods': [{'title': 'Basal Insulin Optimization Phase (BIO)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1036'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '637'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '399'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '331'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Interventional Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '316'}, {'groupId': 'FG002', 'numSubjects': '321'}]}, {'type': 'Intent to Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'all randomized participants who took at least one dose of study drug', 'groupId': 'FG001', 'numSubjects': '315'}, {'comment': 'all randomized participants who took at least one dose of study drug', 'groupId': 'FG002', 'numSubjects': '312'}]}, {'type': 'Per Protocol Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'all randomized participants who completed study and had no violations', 'groupId': 'FG001', 'numSubjects': '247'}, {'comment': 'all randomized participants who completed study and had no violations', 'groupId': 'FG002', 'numSubjects': '263'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '264'}, {'groupId': 'FG002', 'numSubjects': '275'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1036 patients entered the study, 637 were assigned to the two interventional study groups. 10 patients assigned to treatment groups did not receive study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)'}, {'id': 'BG001', 'title': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)'}, {'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': '180', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '9.27', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '9.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'prior use of Sulfonylurea (SU)', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.27', 'spread': '0.983', 'groupId': 'BG000'}, {'value': '8.21', 'spread': '0.871', 'groupId': 'BG001'}, {'value': '8.24', 'spread': '0.927', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'per protocol population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1036}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2009-08-17', 'resultsFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-21', 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30', 'timeFrame': 'Baseline, 30 weeks', 'description': 'Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HbA1C < 7.0%', 'timeFrame': 'Week 30', 'description': 'Percentage of participants achieving HbA1C \\< 7.0%'}, {'measure': 'Percent of Participants Achieving HbA1c ≤ 6.5%.', 'timeFrame': 'Week 30', 'description': 'Percent of participants achieving HbA1c ≤ 6.5%.'}, {'measure': 'Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.'}, {'measure': 'Change in Total Cholesterol From Baseline to Week 30', 'timeFrame': 'Baseline, week 30', 'description': "Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate."}, {'measure': 'Change in High Density Lipoprotein (HDL) From Baseline to Week 30', 'timeFrame': 'Baseline, week 30', 'description': "Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate."}, {'measure': 'Change in Low Density Lipoprotein (LDL) From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': "Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate."}, {'measure': 'Change in Body Weight From Baseline to Week 30.', 'timeFrame': 'baseline, week 30', 'description': 'Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.'}, {'measure': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 30', 'timeFrame': 'Baseline, Week 30', 'description': 'Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.'}, {'measure': 'Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30', 'timeFrame': 'baseline, Week 30', 'description': 'Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.'}, {'measure': 'Daily Insulin Glargine Dose at Baseline and at Week 30', 'timeFrame': 'Baseline, week 30', 'description': 'Daily Insulin Glargine Dose at baseline and at Week 30'}, {'measure': 'Major Hypoglycemia Rate Per Year', 'timeFrame': '30 weeks', 'description': 'Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.'}, {'measure': 'Minor Hypoglycemia Rate Per Year', 'timeFrame': '30 weeks', 'description': 'Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose \\<3.0 mmol/L (54 mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'Byetta', 'insulin lispro', 'Humalog', 'insulin glargine', 'Lantus', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25011946', 'type': 'RESULT', 'citation': 'Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.\n* Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:\n\n * Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or\n * Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.\n* Have an HbA1C \\> 7.0% and ≤ 10.0%.\n* Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.\n\nExclusion Criteria:\n\n* Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.\n* Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).\n* Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.\n* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.\n* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have previously completed or been withdrawn from this study after enrollment.'}, 'identificationModule': {'nctId': 'NCT00960661', 'briefTitle': 'A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea', 'orgStudyIdInfo': {'id': 'H8O-EW-GWDM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exenatide (BET)', 'description': 'Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)', 'interventionNames': ['Drug: exenatide', 'Drug: Metformin', 'Drug: Insulin/ Glargine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro (BBT)', 'description': 'Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)', 'interventionNames': ['Drug: insulin lispro', 'Drug: Metformin', 'Drug: Insulin/ Glargine']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day', 'armGroupLabels': ['Exenatide (BET)']}, {'name': 'insulin lispro', 'type': 'DRUG', 'otherNames': ['Humalog'], 'description': 'titrated based on pre-meal glucose level; three times a day', 'armGroupLabels': ['Insulin Lispro (BBT)']}, {'name': 'Metformin', 'type': 'DRUG', 'armGroupLabels': ['Exenatide (BET)', 'Insulin Lispro (BBT)']}, {'name': 'Insulin/ Glargine', 'type': 'DRUG', 'armGroupLabels': ['Exenatide (BET)', 'Insulin Lispro (BBT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Research Site'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Research Site'}, {'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Research Site'}, {'city': 'Ciudad de 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