Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-12 @ 8:09 PM
Study NCT ID:
NCT00469092
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2007-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'C057619', 'term': 'glimepiride'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of any plans for publications and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse event were collected in a time span of 26 weeks.', 'description': 'The safety analysis population consists of all subjects exposed to trial products.', 'eventGroups': [{'id': 'EG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride', 'otherNumAtRisk': 231, 'otherNumAffected': 56, 'seriousNumAtRisk': 231, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride', 'otherNumAtRisk': 238, 'otherNumAffected': 63, 'seriousNumAtRisk': 238, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 40, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Biliary Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis Escherichia Coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Otitis Media Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Perianal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia Primary Atypical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vascular Graft Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diabetic Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypoglycaemic Unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': "Dupuytren's Contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Guillain-Barre Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypoglycaemic Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Wart Excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arterial Thrombosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'classes': [{'categories': [{'measurements': [{'value': '7.08', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '7.23', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '-0.02', 'pValueComment': 'P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.', 'groupDescription': 'HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After 26 weeks of treatment', 'description': 'Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.'}, {'type': 'SECONDARY', 'title': '9-point Self-measured Plasma Glucose Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'classes': [{'title': 'Before breakfast', 'categories': [{'measurements': [{'value': '6.73', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': '2 hours after breakfast', 'categories': [{'measurements': [{'value': '9.40', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '9.07', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Before lunch', 'categories': [{'measurements': [{'value': '7.24', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': '2 hours after lunch', 'categories': [{'measurements': [{'value': '8.90', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '8.98', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Before dinner', 'categories': [{'measurements': [{'value': '7.90', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '7.80', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': '2 hours after dinner', 'categories': [{'measurements': [{'value': '8.66', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '9.18', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Before bedtime', 'categories': [{'measurements': [{'value': '7.77', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '8.54', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': '02:00-04:00 AM', 'categories': [{'measurements': [{'value': '6.56', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Before breakfast following day', 'categories': [{'measurements': [{'value': '6.65', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.', 'groupDescription': 'The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After 26 weeks of treatment', 'description': 'Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'classes': [{'title': 'HbA1c <= 6.5% of haemoglobin', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c < 7.0% of haemoglobin', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Reduction > 1% point from baseline', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c < 7% no nocturnal hypoglycemia', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c < 7%, no daytime hypoglycemia', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c < 7%, no hypoglycemia', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.914', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.47', 'estimateComment': 'The OR and 95% CI is for the HbA1c \\<= 6.5% treatment target.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.014', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.54', 'estimateComment': 'The OR and 95% CI is for the HbA1c \\< 7.0% treatment target.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.131', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.77', 'estimateComment': 'The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.905', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.38', 'estimateComment': 'The OR and 95% CI is for the HbA1c \\< 7% no nocturnal (00:00-06:00) hypoglycemia treatment target', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.181', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.87', 'estimateComment': 'The OR and 95% CI is for the HbA1c \\< 7%, no daytime (06:01-23:59) hypoglycemia treatment target', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.122', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.82', 'estimateComment': 'The OR and 95% CI is for the HbA1c \\< 7%, no hypoglycemia treatment target.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After 26 weeks of treatment', 'description': 'The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c \\<= 6.5% of haemoglobin and HbA1c \\< 7% of haemoglobin.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'classes': [{'title': 'Burden Score', 'categories': [{'measurements': [{'value': '83.10', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '83.06', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy Score', 'categories': [{'measurements': [{'value': '73.25', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '73.47', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms Score', 'categories': [{'measurements': [{'value': '72.42', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '72.81', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Overall Score', 'categories': [{'measurements': [{'value': '76.53', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '76.64', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '2.48', 'estimateComment': 'The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.', 'groupDescription': 'The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-3.56', 'ciUpperLimit': '3.11', 'estimateComment': 'The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.', 'groupDescription': 'The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-3.14', 'ciUpperLimit': '2.35', 'estimateComment': 'The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.', 'groupDescription': 'The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '2.14', 'estimateComment': 'The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.', 'groupDescription': 'Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After 26 weeks of treatment', 'description': 'Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'classes': [{'title': 'Minor', 'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}]}, {'title': 'Symptom only', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}, {'title': 'Major', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all subjects exposed to trial products.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'FG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '241'}]}, {'type': 'Exposed to Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '238'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Incorrectly Randomised', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Contraindication metformin/glimepiride', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Use of lipid lowering drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Hypoglycaemic Episodes', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Abnormal lab value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Use of Corticosteroid', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled 64 sites in 15 countries in Africa, Europe, Asia, North America and South America.', 'preAssignmentDetails': 'A screening period of 1-2 weeks was followed by a run-in period of 4 weeks during which metformin was titrated to maximum 2550 mg and glimepiride to 4 mg, at the discretion of the investigator. Subjects who were already taking 4, 6 or 8 mg glimepiride continued on this dose. Doses were kept constant during the last week prior to randomisation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 + metformin + glimepiride'}, {'id': 'BG001', 'title': 'Glargine', 'description': 'Insulin glargine + metformin + glimepiride'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes duration', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '9.5', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '9.3', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years since diagnosis of diabetes', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Glycosylated Haemoglobin', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '77.3', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '77.4', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2007-05-03', 'resultsFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2007-05-03', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-30', 'studyFirstPostDateStruct': {'date': '2007-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'After 26 weeks of treatment', 'description': 'Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': '9-point Self-measured Plasma Glucose Profiles', 'timeFrame': 'After 26 weeks of treatment', 'description': 'Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.'}, {'measure': 'Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'After 26 weeks of treatment', 'description': 'The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c \\<= 6.5% of haemoglobin and HbA1c \\< 7% of haemoglobin.'}, {'measure': 'Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)', 'timeFrame': 'After 26 weeks of treatment', 'description': 'Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.'}, {'measure': 'Number of Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-26', 'description': 'Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.'}, {'measure': 'Number of Subjects Reporting Treatment Emergent Adverse Events', 'timeFrame': 'Weeks 0-26', 'description': 'Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '19821654', 'type': 'RESULT', 'citation': 'Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.'}, {'pmid': '20363044', 'type': 'RESULT', 'citation': 'Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Africa, Asia, Europe, Oceania and South America.\n\nThis trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months\n* Ongoing stable treatment with metformin for at least 2 months\n* Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months\n* Insulin naive\n* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)\n\nExclusion Criteria:\n\n* Metformin contraindication according to local practice\n* TZD (thiazolidinedione) treatment for the last 5 months before trial start\n* Systemic treatment with any corticosteroid 3 months before trial start\n* Any disease or condition which according to the Investigator would interfere with the trial'}, 'identificationModule': {'nctId': 'NCT00469092', 'briefTitle': 'Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BIASP-1731'}, 'secondaryIdInfos': [{'id': '2006-003288-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIAsp 30', 'interventionNames': ['Drug: biphasic insulin aspart', 'Drug: metformin', 'Drug: glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glargine', 'interventionNames': ['Drug: insulin glargine', 'Drug: metformin', 'Drug: glimepiride']}], 'interventions': [{'name': 'biphasic insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.', 'armGroupLabels': ['BIAsp 30']}, {'name': 'insulin glargine', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.', 'armGroupLabels': ['Glargine']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Tablets, 2550 mcg. Administered once daily.', 'armGroupLabels': ['BIAsp 30', 'Glargine']}, {'name': 'glimepiride', 'type': 'DRUG', 'description': 'Tablets 2 mg. 4, 6 or 8 mg administered once daily.', 'armGroupLabels': ['BIAsp 30', 'Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1405CWB', 'city': 'Ciudad Autonoma de Bs As', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'C1406FWY', 'city': 'Ciudad Autónoma de BsAs', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'B7602CBM', 'city': 'Mar del Plata', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'A - 6900', 'city': 'Bregenz', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.50311, 'lon': 9.7471}}, {'zip': '6807', 'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '3160', 'city': 'Traisen', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.03333, 'lon': 15.6}}, {'zip': '1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '06250', 'city': 'Mougins', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.60068, 'lon': 6.99523}}, {'zip': '11108', 'city': 'Narbonne', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.18396, 'lon': 3.00141}}, {'zip': '58033', 'city': 'Nevers', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.98956, 'lon': 3.159}}, {'zip': '97159', 'city': 'Pointe à Pitre', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'zip': '380006', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '132001', 'city': 'Karnāl', 'state': 'Haryana', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.69197, 'lon': 76.98448}}, {'zip': '560043', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '530001', 'city': 'Visakhapatnam', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '56000', 'city': 'Cheras', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 3.108, 'lon': 101.726}}, {'zip': '16150', 'city': 'Kota Bharu, Kelantan', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}, {'zip': '10990', 'city': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 3.55, 'lon': 102.56667}}, {'zip': '44600', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44620', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '42060', 'city': 'Pachuca', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}, {'zip': '1311RL', 'city': 'Almere Stad', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '9711 SG', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2352 RA', 'city': 'Leiderdorp', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'zip': '3021 HC', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '2724 EK', 'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}, {'zip': '1014', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1100', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1102', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-858', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '81-366', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '59-301', 'city': 'Lubin', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '10-561', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '60-821', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '35-301', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '71-455', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '440055', 'city': 'Satu Mare', 'state': 'Satu Mare County', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.79926, 'lon': 22.86255}}, {'zip': '710224', 'city': 'Botoșani', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.75, 'lon': 26.66667}}, {'zip': '020475', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '800371', 'city': 'Galati', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'zip': '130083', 'city': 'Târgovişte', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '18000', 'city': 'Nis', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4091', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '46600', 'city': 'Alzira', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29009', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}