Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT01060059
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day', 'otherNumAtRisk': 444, 'otherNumAffected': 19, 'seriousNumAtRisk': 444, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment", 'otherNumAtRisk': 438, 'otherNumAffected': 9, 'seriousNumAtRisk': 438, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperamylasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperlipasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pancreatitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Metabolic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Coma hepatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '30.32', 'upperLimit': '39.93'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '12.39', 'upperLimit': '19.73'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.'}, {'type': 'SECONDARY', 'title': 'Changes in HbA1c From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in HbA1c from Baseline to Month 12', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Blood Glucose From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-26.7', 'spread': '57.05', 'groupId': 'OG000'}, {'value': '-51.4', 'spread': '64.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting Blood Glucose From Baseline to Month 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of Patients with HbA1c Reduction from Baseline \\>= 1.0% at Month 12', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<=7.0% at Month 12', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<6.5% at Month 12', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Weight From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '4.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Weight From Baseline to Month 12', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of Patients Achieving a Weight Decrease \\>=3% between Baseline and Month 12', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of Patients Achieving a Weight Decrease \\>=5% between Baseline and Month 12', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Total Cholesterol Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-6.0', 'spread': '36.22', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '43.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting Total Cholesterol Between Baseline and Month 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting HDL Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '10.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting HDL Between Baseline and Month 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting LDL Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '30.79', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '38.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting LDL Between Baseline and Month 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Triglycerides Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-16.5', 'spread': '115.27', 'groupId': 'OG000'}, {'value': '-30.2', 'spread': '108.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting Triglycerides Between Baseline and Month 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Diastolic Blood Pressure Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '10.40', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '10.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Diastolic Blood Pressure Between Baseline and Month 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Changes in Systolic Blood Pressure Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '18.74', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '17.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Systolic Blood Pressure Between Baseline and Month 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 12', 'description': 'Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.\n\nAll episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.\n\nPatients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes'}, {'type': 'SECONDARY', 'title': 'Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'title': 'Male Gender', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.46'}, {'value': '247', 'groupId': 'OG001'}]}]}, {'title': 'Female Gender', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'Medical conditions present', 'categories': [{'measurements': [{'value': '371', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1.76'}, {'value': '363', 'groupId': 'OG001'}]}]}, {'title': 'No medical conditions', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Previous gastrointestinal symptoms present', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '3.42'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'No gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.831', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.46', 'groupDescription': 'Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}, {'pValue': '0.554', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.76', 'pValueComment': 'Baseline Medical conditions (yes vs. no)', 'groupDescription': 'Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.714', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.43', 'ciUpperLimit': '3.42', 'pValueComment': 'Baseline gastrointestinal symptoms (yes vs. no)', 'groupDescription': 'Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.'}, {'type': 'SECONDARY', 'title': 'Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.78', 'groupDescription': 'Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).', 'unitOfMeasure': 'Percentage of normal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.\n\nFAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443.'}, {'type': 'SECONDARY', 'title': 'Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '8.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.00', 'groupDescription': 'Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.'}, {'type': 'SECONDARY', 'title': 'Factor of Older Age Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '9.65', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '9.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.95', 'ciUpperLimit': '0.99', 'groupDescription': 'Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.'}, {'type': 'SECONDARY', 'title': 'Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '5.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.23', 'groupDescription': 'Logistic regression analysis was used to determine if higher BMI (1 kg/m\\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m\\^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m\\^2.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.\n\nFAS for basal insulin arm=438 but one patient did not have data in this arm so n=437.'}, {'type': 'SECONDARY', 'title': 'Factor of Greater Height Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'categories': [{'measurements': [{'value': '165.8', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '164.4', 'spread': '9.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.05', 'groupDescription': 'Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.\n\nFAS for basal insulin arm=438 but one patient did not provide height data so n=437.'}, {'type': 'SECONDARY', 'title': 'Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.'}, {'id': 'OG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'classes': [{'title': 'Creatinine (N=324, 333)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'HDL (N=335, 326)', 'categories': [{'measurements': [{'value': '44.7', 'spread': '12.82', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '12.31', 'groupId': 'OG001'}]}]}, {'title': 'Total Cholesterol (N=368, 355)', 'categories': [{'measurements': [{'value': '181.1', 'spread': '40.00', 'groupId': 'OG000'}, {'value': '182.7', 'spread': '41.79', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides (N=364, 360)', 'categories': [{'measurements': [{'value': '177.5', 'spread': '112.57', 'groupId': 'OG000'}, {'value': '173.6', 'spread': '104.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.77', 'groupDescription': 'Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}, {'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.00', 'groupDescription': 'Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}, {'pValue': '0.259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.01', 'groupDescription': 'Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}, {'pValue': '0.123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.00', 'groupDescription': 'Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "If several variables had Spearman's rho \\> 0.4 (for continuous) and Cramer's V \\> 0.4 (for categorical covariates), only one was left in the model.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'FG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '438'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '377'}, {'groupId': 'FG001', 'numSubjects': '371'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '67'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'lack of glycemic control', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'lack of compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Six patients were not assigned to any cohort because the type of treatment taken was not reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '882', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.\n\nexenatide : subcutaneous injection, 5mcg or 10mcg, twice a day'}, {'id': 'BG001', 'title': 'Basal Insulin', 'description': "The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.\n\nbasal insulin : subcutaneous injection, dosing according to physician's clinical judgment"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '9.65', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '9.62', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '10.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '97.5', 'spread': '21.39', 'groupId': 'BG000'}, {'value': '79.5', 'spread': '15.82', 'groupId': 'BG001'}, {'value': '88.6', 'spread': '20.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.34', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '1.40', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '1.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 888}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2010-01-29', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-27', 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.'}], 'secondaryOutcomes': [{'measure': 'Changes in HbA1c From Baseline to Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in HbA1c from Baseline to Month 12'}, {'measure': 'Changes in Fasting Blood Glucose From Baseline to Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting Blood Glucose From Baseline to Month 12'}, {'measure': 'Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of Patients with HbA1c Reduction from Baseline \\>= 1.0% at Month 12'}, {'measure': 'Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12', 'timeFrame': 'Month 12', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<=7.0% at Month 12'}, {'measure': 'Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12', 'timeFrame': 'Month 12', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<6.5% at Month 12'}, {'measure': 'Changes in Weight From Baseline to Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Weight From Baseline to Month 12'}, {'measure': 'Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of Patients Achieving a Weight Decrease \\>=3% between Baseline and Month 12'}, {'measure': 'Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Percentage of Patients Achieving a Weight Decrease \\>=5% between Baseline and Month 12'}, {'measure': 'Changes in Fasting Total Cholesterol Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting Total Cholesterol Between Baseline and Month 12'}, {'measure': 'Changes in Fasting HDL Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting HDL Between Baseline and Month 12'}, {'measure': 'Changes in Fasting LDL Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting LDL Between Baseline and Month 12'}, {'measure': 'Changes in Fasting Triglycerides Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Fasting Triglycerides Between Baseline and Month 12'}, {'measure': 'Changes in Diastolic Blood Pressure Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Diastolic Blood Pressure Between Baseline and Month 12'}, {'measure': 'Changes in Systolic Blood Pressure Between Baseline and Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Changes in Systolic Blood Pressure Between Baseline and Month 12'}, {'measure': 'Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.\n\nAll episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.'}, {'measure': 'Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.'}, {'measure': 'Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).'}, {'measure': 'Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.'}, {'measure': 'Factor of Older Age Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.'}, {'measure': 'Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m\\^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m\\^2.'}, {'measure': 'Factor of Greater Height Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .'}, {'measure': 'Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline', 'timeFrame': 'baseline', 'description': 'Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA).\n\nObservational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c \\> 7.0%\n2. Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA\n3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study\n4. Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease\n5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry\n6. Have been fully informed and given their written consent for use of their data'}, 'identificationModule': {'nctId': 'NCT01060059', 'briefTitle': 'Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'EBIRIOS - Exenatide and Basal Insulins Use in the Real Setting: an Italian Observational Study in Patients With Type 2 Diabetes and Secondary Failure of Oral Antihyperglycemic Treatment', 'orgStudyIdInfo': {'id': 'H8O-IT-B014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'exenatide', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.', 'interventionNames': ['Drug: exenatide']}, {'label': 'basal insulin', 'description': 'The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.', 'interventionNames': ['Drug: basal insulin']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['BYETTA'], 'description': 'subcutaneous injection, 5mcg or 10mcg, twice a day', 'armGroupLabels': ['exenatide']}, {'name': 'basal insulin', 'type': 'DRUG', 'description': "subcutaneous injection, dosing according to physician's clinical judgment", 'armGroupLabels': ['basal insulin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Acquaviva delle Fonti', 'country': 'Italy', 'facility': 'Research site', 'geoPoint': {'lat': 40.89704, 'lon': 16.8433}}, {'city': 'Anzio', 'country': 'Italy', 'facility': 'Research site', 'geoPoint': {'lat': 41.45263, 'lon': 12.62157}}, {'city': 'Bassano del Grappa', 'country': 'Italy', 'facility': 'Research site', 'geoPoint': {'lat': 45.76656, 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