Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-01 @ 8:22 AM
Study NCT ID:
NCT00807092
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control 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': 'C575870', 'term': 'biphasic human insulin 30'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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 reserves the right to not release data until specified milestones. This includes the right to not release interim results of clinical trials. At the end of the trial, manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected in a time span of 6 weeks (starting from the start of treatment to the end of treatment plus one day)', 'description': 'The safety analysis set contains all randomised subjects exposed to at least one dose of trial drug(s).', 'eventGroups': [{'id': 'EG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.', 'otherNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.', 'otherNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Loose body in joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-1.977', 'spread': '0.517', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.013', 'ciLowerLimit': '-1.332', 'ciUpperLimit': '1.306', 'pValueComment': 'A statistical significant threshold p less than 0.025', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.666', 'estimateComment': 'BIAsp 30 - BHI 30', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol\\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol\\*h/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (visit 2) value of mean IAUC(0-4hours) as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 6', 'description': 'The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'title': 'Breakfast, N=68, 64', 'categories': [{'measurements': [{'value': '-3.094', 'spread': '0.725', 'groupId': 'OG000'}, {'value': '-4.272', 'spread': '0.765', 'groupId': 'OG001'}]}]}, {'title': 'Lunch, N=69, 66', 'categories': [{'measurements': [{'value': '1.651', 'spread': '0.897', 'groupId': 'OG000'}, {'value': '1.969', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Dinner, N=69, 65', 'categories': [{'measurements': [{'value': '-4.775', 'spread': '0.539', 'groupId': 'OG000'}, {'value': '-4.026', 'spread': '0.566', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.178', 'ciLowerLimit': '-0.802', 'ciUpperLimit': '3.157', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1', 'estimateComment': 'Breakfast', 'groupDescription': 'Null hypothesis and alternative hypothesis for breakfast:\n\nThe null hypothesis (H0) was:\n\nH0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol\\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol\\*h/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)', 'testedNonInferiority': False}, {'pValue': '0.794', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.318', 'ciLowerLimit': '-2.724', 'ciUpperLimit': '2.087', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.216', 'estimateComment': 'Lunch', 'groupDescription': 'Null hypothesis and alternative hypothesis for lunch:\n\nThe null hypothesis (H0) was:\n\nH0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol\\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol\\*h/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)', 'testedNonInferiority': False}, {'pValue': '0.3093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.749', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '0.703', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Dinner', 'groupDescription': 'Null hypothesis and alternative hypothesis for dinner:\n\nThe null hypothesis (H0) was:\n\nH0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol\\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol\\*h/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, Week 6', 'description': 'The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Mean FBG (Fasting Blood Glucose) Assessed by CGMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.861', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '6.414', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0891', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.448', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.964', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.261', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': 'The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Change in Mean FBG Assessed by CGMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.114', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '-2.561', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 6', 'description': 'The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in FPG (Fasting Plasma Glucose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.961', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '-3.456', 'spread': '0.188', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0472', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.495', 'ciLowerLimit': '0.0060', 'ciUpperLimit': '0.984', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.247', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, Week 6', 'description': 'FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'title': 'Before Breakfast, N=71, 68', 'categories': [{'measurements': [{'value': '-2.27', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': '2 hours after Breakfast, N=69, 69', 'categories': [{'measurements': [{'value': '-3.99', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-5.22', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Before Lunch, N=71, 68', 'categories': [{'measurements': [{'value': '-3.46', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': '2 hours after Lunch, N=70, 69', 'categories': [{'measurements': [{'value': '-2.24', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-2.41', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Before dinner, N=70, 69', 'categories': [{'measurements': [{'value': '-2.59', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': '2 hours after Dinner, N=70, 69', 'categories': [{'measurements': [{'value': '-4.57', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime, N=71, 68', 'categories': [{'measurements': [{'value': '-3.84', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-4.03', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': '3AM, N=68, 66', 'categories': [{'measurements': [{'value': '-2.62', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-3.39', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Average, N=71, 69', 'categories': [{'measurements': [{'value': '-3.16', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.63', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Before breakfast', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 2) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.15', 'ciUpperLimit': '2.31', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': '2 hours after breakfast', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '1.08', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Before lunch', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.747', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '1.19', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': '2 hours after lunch', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.69', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Before dinner', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.326', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '0.48', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': '2 hours after dinner', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.643', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.99', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Bedtime', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.0080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.33', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': '3 AM', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}, {'pValue': '0.274', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.75', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Average', 'groupDescription': 'For each endpoint of SMBG :The null hypothesis (H0) was:\n\nH0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of BG as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, Week 6', 'description': 'Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products'}, {'type': 'SECONDARY', 'title': 'Change in Prandial Blood Glucose Increment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'title': 'Breakfast, N=69, 68', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-2.82', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Lunch, N=70, 68', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Dinner, N=69, 69', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-1.85', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Average, N=70, 68', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '2.04', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Breakfast', 'groupDescription': 'For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:\n\nH0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate', 'testedNonInferiority': False}, {'pValue': '0.933', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '1.22', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Lunch', 'groupDescription': 'For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:\n\nH0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate', 'testedNonInferiority': False}, {'pValue': '0.922', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '1.05', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Dinner', 'groupDescription': 'For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:\n\nH0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.85', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'estimateComment': 'Average', 'groupDescription': 'For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:\n\nH0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, Week 6', 'description': 'Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.499', 'spread': '0.273', 'groupId': 'OG000'}, {'value': '-0.686', 'spread': '0.284', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.187', 'ciLowerLimit': '-0.547', 'ciUpperLimit': '0.921', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.371', 'groupDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, Week 6', 'description': 'MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Change in GA (Glycated Albumin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.147', 'spread': '0.428', 'groupId': 'OG000'}, {'value': '-6.474', 'spread': '0.438', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5706', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.328', 'ciLowerLimit': '-0.813', 'ciUpperLimit': '1.468', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.577', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment≠0 %', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of GA as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week -2, week 6', 'description': 'Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.', 'unitOfMeasure': 'percentage point change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Change in Glycosylated Haemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.647', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-1.667', 'spread': '0.086', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.243', 'ciUpperLimit': '0.243', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.113', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week -2, week 6', 'unitOfMeasure': 'percentage point change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.'}, {'type': 'SECONDARY', 'title': 'Duration of Hypoglycaemic Events Based on CGMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'title': 'Blood glucose < 3.5 mmol/L, N=70, 68', 'categories': [{'measurements': [{'value': '0.304', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.358', 'spread': '0.097', 'groupId': 'OG001'}]}]}, {'title': 'Blood glucose < 2.5 mmol/L, N=70, 68', 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.029', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.671', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.054', 'ciLowerLimit': '-0.307', 'ciUpperLimit': '0.198', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'estimateComment': 'Blood glucose below 3.5 mmol/l', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate', 'testedNonInferiority': False}, {'pValue': '0.7544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.088', 'ciUpperLimit': '0.064', 'pValueComment': 'A statistical significant threshold p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.038', 'estimateComment': 'Blood glucose below 2.5 mmol/l', 'groupDescription': 'The null hypothesis (H0) was:\n\nH0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '72-hour monitoring period at Week 0 and Week 6', 'description': 'The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemia Based on Self-reported Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'OG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'classes': [{'title': 'All', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Major', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms only', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-6', 'description': 'Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified 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 self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'FG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'Exposed to Drug', 'achievements': [{'comment': 'Subject was randomised, but not exposed to any trial drug', 'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'CGMS data collection failed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 10 sites across China', 'preAssignmentDetails': 'All eligible subjects had their baseline blood glucose profiles monitored by continuous glucose monitoring system (CGMS) for 72 hours. Following CGMS uninstall and discontinuation of all previous oral anti-diabetic drug (OAD) treatment, subjects were randomised to one of two treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'BG001', 'title': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '9', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '66.28', 'spread': '12', 'groupId': 'BG000'}, {'value': '65.49', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '65.88', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height at screening', 'classes': [{'categories': [{'measurements': [{'value': '1.634', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '1.623', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '1.628', 'spread': '0.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '24.68', 'spread': '3', 'groupId': 'BG000'}, {'value': '24.74', 'spread': '3', 'groupId': 'BG001'}, {'value': '24.71', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of diagnosed diabetes', 'classes': [{'categories': [{'measurements': [{'value': '7.74', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '7.36', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c at screening', 'classes': [{'categories': [{'measurements': [{'value': '9.19', 'spread': '1.05', 'groupId': 'BG000'}, {'value': '9.08', 'spread': '1.08', 'groupId': 'BG001'}, {'value': '9.13', 'spread': '1.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metformin monotherapy or combination therapy at randomisation', 'classes': [{'title': 'Metformin Monotherapy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Metformin Combination Therapy', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'OAD treatment at randomisation', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2008-12-10', 'resultsFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-10', 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals', 'timeFrame': 'Week 0, week 6', 'description': 'The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period'}], 'secondaryOutcomes': [{'measure': 'Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS', 'timeFrame': 'Week 0, Week 6', 'description': 'The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.'}, {'measure': 'Mean FBG (Fasting Blood Glucose) Assessed by CGMS', 'timeFrame': 'Week 6', 'description': 'The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.'}, {'measure': 'Change in Mean FBG Assessed by CGMS', 'timeFrame': 'Week 0, week 6', 'description': 'The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.'}, {'measure': 'Change in FPG (Fasting Plasma Glucose)', 'timeFrame': 'Week 0, Week 6', 'description': 'FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.'}, {'measure': 'Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles', 'timeFrame': 'Week 0, Week 6', 'description': 'Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.'}, {'measure': 'Change in Prandial Blood Glucose Increment', 'timeFrame': 'Week 0, Week 6', 'description': 'Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.'}, {'measure': 'Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS', 'timeFrame': 'Week 0, Week 6', 'description': 'MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS'}, {'measure': 'Change in GA (Glycated Albumin)', 'timeFrame': 'Week -2, week 6', 'description': 'Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.'}, {'measure': 'Change in Glycosylated Haemoglobin (HbA1c)', 'timeFrame': 'Week -2, week 6'}, {'measure': 'Duration of Hypoglycaemic Events Based on CGMS', 'timeFrame': '72-hour monitoring period at Week 0 and Week 6', 'description': 'The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).'}, {'measure': 'Hypoglycaemia Based on Self-reported Episodes', 'timeFrame': 'Weeks 0-6', 'description': 'Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified 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 self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes diagnosed for at least 6 months\n* Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)\n* Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial\n* Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks\n* Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks\n* Glycosylated haemoglobin (HbA1c) between 7.5-11.0%\n* Body Mass Index (BMI) between 18.5 - 35.0 kg/m\\^2\n* Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial product(s) or related products\n* Any contraindication of metformin\n* Receipt of investigational drug within the last 3 months prior to this trial\n* Any history of chronic insulin therapy (more than 1 week of daily use)\n* Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial\n* Pregnancy, nursing mother, or unwillingness to use adequate contraception'}, 'identificationModule': {'nctId': 'NCT00807092', 'briefTitle': 'Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Therapy', 'orgStudyIdInfo': {'id': 'BIASP-3681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIAsp 30', 'description': 'BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.', 'interventionNames': ['Drug: biphasic insulin aspart 30', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'BHI 30', 'description': 'BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.', 'interventionNames': ['Drug: biphasic human insulin 30', 'Drug: metformin']}], 'interventions': [{'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner', 'armGroupLabels': ['BIAsp 30']}, {'name': 'biphasic human insulin 30', 'type': 'DRUG', 'description': 'The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner', 'armGroupLabels': ['BHI 30']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Metformin dose must remain the same as that used prior to the trial.', 'armGroupLabels': ['BHI 30', 'BIAsp 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], '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'}}}}