Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-29 @ 10:27 AM
Study NCT ID:
NCT01486966
Status:
TERMINATED
Last Update Posted:
2017-03-17
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients 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': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D008687', 'term': 'Metformin'}], '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': 'D061266', 'term': 'Insulin, Short-Acting'}, {'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, for example, when the clinical trial report is available. At the end of the trial, one or more 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}, 'limitationsAndCaveats': {'description': 'The size of population analysed in study was smaller than that planned in the protocol. Therefore, the superiority of experimental products to comparator could not be concluded with sufficient statistical power.'}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected in a timeframe of 2 weeks.', 'description': 'Safety analysis set included all subjects receiving at least one dose of the trial products. All adverse events summarised were treatment emergent adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.', 'otherNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'upper restiratory tract infection', 'notes': 'In the clinical trial report, the overall conclusion "No adverse event (AE) with incidence ≥ 5 % was reported in this trial" was based on treatment emergent AEs experienced by at least 5% of all subjects. The incidence in the total subjects was 3.4%.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.84', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-2.80', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 2', 'description': 'Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.22', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-2.29', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 2', 'description': 'The FPG referred to pre-breakfast plasma glucose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.00', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-3.47', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 2', 'description': 'The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.47', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-2.87', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 2', 'description': 'The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'unitOfMeasure': 'percentage (%) of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000'}, {'value': '34.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'unitOfMeasure': 'percentage (%) of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'FPG target was \\< 6.0 mmol / L, 2hPPG target was \\< 8.0 mmol / L.', 'unitOfMeasure': 'percentage (%) of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000'}, {'value': '34.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'FPG target was \\< 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).', 'unitOfMeasure': 'percentage (%) of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fructosamine After Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.0', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '-23.7', 'spread': '5.50', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 2', 'unitOfMeasure': 'Umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'OG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'classes': [{'title': 'All events', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Diurnal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-2', 'description': 'All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.\n\nSevere hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) \\< 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value \\< 3.1 mmol/l (56 mg/dl).\n\nA hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all subjects receiving at least one dose of the trial products.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'FG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 6 centres in China participated.', 'preAssignmentDetails': 'Between screening and treatment with trial drugs, subjects were assessed for eligibility and were randomised 1:1 into one of the two treatment arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Detemir + Insulin Aspart ± Metformin', 'description': 'Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'BG001', 'title': 'Insulin NPH + Human Soluble Insulin ± Metformin', 'description': 'Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', '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': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', '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', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164.2', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '164.2', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '164.2', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.09', 'spread': '3.13', 'groupId': 'BG000'}, {'value': '24.63', 'spread': '2.67', 'groupId': 'BG001'}, {'value': '25.36', 'spread': '2.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-trial treatment of oral antidiabetic drug', 'classes': [{'title': 'Acarbose', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Gliclazide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Glimepiride', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Metformin', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Metformin hydrochloride', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Repaglinide', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-trial insulin treatment', 'classes': [{'title': 'basal insulin (once daily)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'premixed insulin (twice daily)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated haemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.76', 'spread': '0.73', 'groupId': 'BG000'}, {'value': '8.49', 'spread': '0.76', 'groupId': 'BG001'}, {'value': '8.62', 'spread': '0.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type 2 diabetes', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of diagnosed diabetes', 'classes': [{'categories': [{'measurements': [{'value': '10.23', 'spread': '5.08', 'groupId': 'BG000'}, {'value': '11.97', 'spread': '7.14', 'groupId': 'BG001'}, {'value': '11.10', 'spread': '6.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes complications', 'classes': [{'title': 'Diabetic complications', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Diabetic retinopathy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Diabetic neuropathy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Diabetic Nephropathy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Macroangiopathy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Trial terminated prematurely due to slow recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2011-12-05', 'resultsFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-04-22', 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment', 'timeFrame': 'Week 0, week 2', 'description': 'Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment', 'timeFrame': 'Week 0, week 2', 'description': 'The FPG referred to pre-breakfast plasma glucose.'}, {'measure': 'Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment', 'timeFrame': 'Week 0, week 2', 'description': 'The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.'}, {'measure': 'Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment', 'timeFrame': 'Week 0, week 2', 'description': 'The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.'}, {'measure': 'Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment', 'timeFrame': 'Week 2'}, {'measure': 'Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment', 'timeFrame': 'Week 2'}, {'measure': 'Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment', 'timeFrame': 'Week 2', 'description': 'FPG target was \\< 6.0 mmol / L, 2hPPG target was \\< 8.0 mmol / L.'}, {'measure': 'Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment', 'timeFrame': 'Week 2', 'description': 'FPG target was \\< 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).'}, {'measure': 'Change From Baseline in Fructosamine After Two Weeks of Treatment', 'timeFrame': 'Week 0, week 2'}, {'measure': 'Incidence of Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-2', 'description': 'All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.\n\nSevere hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) \\< 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value \\< 3.1 mmol/l (56 mg/dl).\n\nA hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Guo X, Li Q, Shi Y, Bu R, Liu J, Qu S, Gao Y. Efficacy and safety of insulin detemir plus insulin aspart versus NPH insulin plus human soluble insulin with or without metformin in Chinese type 2 diabetes. Chinese J Diabetes 2014; 22 (1)'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.\n\nThe trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer\n* Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)\n* Body Mass Index (BMI) equal to 40 kg/m\\^2 or below\n* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis\n* Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation\n\nExclusion Criteria:\n\n* Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening\n* Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors\n* Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)'}, 'identificationModule': {'nctId': 'NCT01486966', 'briefTitle': 'Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in Chinese Inpatients With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment', 'orgStudyIdInfo': {'id': 'NN304-3954'}, 'secondaryIdInfos': [{'id': 'U1111-1123-7088', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin detemir / IAsp', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart', 'Drug: metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insulin NPH', 'interventionNames': ['Drug: insulin NPH', 'Drug: human soluble insulin', 'Drug: metformin']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4', 'armGroupLabels': ['Insulin detemir / IAsp']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4', 'armGroupLabels': ['Insulin detemir / IAsp']}, {'name': 'insulin NPH', 'type': 'DRUG', 'description': 'Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4', 'armGroupLabels': ['insulin NPH']}, {'name': 'human soluble insulin', 'type': 'DRUG', 'description': 'Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4', 'armGroupLabels': ['insulin NPH']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'For subjects previously treated with metformin, the dosage and frequency will be kept unchanged', 'armGroupLabels': ['Insulin detemir / IAsp', 'insulin NPH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '214023', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '200003', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], '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'}}}}