Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-11 @ 11:34 PM
Study NCT ID:
NCT00613951
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2008-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin 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': 'C578220', 'term': 'insulin degludec, insulin aspart drug combination'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'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 maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected in a time frame of 16 weeks + 5 days follow up', 'description': 'The safety analysis set included all subjects with exposure information of at least one dose of randomised trial medication.', 'eventGroups': [{'id': 'EG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.', 'otherNumAtRisk': 60, 'otherNumAffected': 14, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.', 'otherNumAtRisk': 59, 'otherNumAffected': 13, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.', 'otherNumAtRisk': 62, 'otherNumAffected': 13, 'seriousNumAtRisk': 62, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Haemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.79', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-1.84', 'spread': '0.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 16', 'description': 'Change from baseline in HbA1c after 16 weeks of treatment', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis'}, {'type': 'SECONDARY', 'title': 'Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.52', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '7.52', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing.'}, {'type': 'SECONDARY', 'title': 'Rate of Major and Minor Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '679', 'groupId': 'OG001'}, {'value': '730', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16 + 5 days follow up', 'description': 'Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.', 'unitOfMeasure': 'Episodes/100 years of patient exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Rate of Nocturnal Major and Minor Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16 + 5 days follow up', 'description': 'Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).', 'unitOfMeasure': 'Episodes/100 years of patient exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Rate of Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Adverse events (AEs)', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Moderate AEs', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Mild AEs', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}]}, {'title': 'Fatal AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16 + 5 days follow up', 'description': "Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.", 'unitOfMeasure': 'Events/100 years of patient exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.'}, {'type': 'SECONDARY', 'title': 'Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Week -4, N=60, 57, 62', 'categories': [{'measurements': [{'value': '33.0', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '36.9', 'spread': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 16, N=54, 57, 53', 'categories': [{'measurements': [{'value': '22.9', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '11.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -4, Week 16', 'description': 'Laboratory values at screening (Week -4) and at Week 16', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.'}, {'type': 'SECONDARY', 'title': 'Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Week -4, N=60, 56, 62', 'categories': [{'measurements': [{'value': '23.6', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 16, N=54, 57, 53', 'categories': [{'measurements': [{'value': '22.6', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '23.1', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -4, Week 16', 'description': 'Laboratory values at screening (Week -4) and at Week 16', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.'}, {'type': 'SECONDARY', 'title': 'Laboratory Safety Parameters (Biochemistry): Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Week -4, N=60, 57, 62', 'categories': [{'measurements': [{'value': '72.7', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '74.8', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 16, N=56, 57, 56', 'categories': [{'measurements': [{'value': '73.6', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '78.1', 'spread': '15.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week -4, Week 16', 'description': 'Laboratory values at screening (Week -4) and at Week 16', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Week 0 (Baseline), N=60, 59, 62', 'categories': [{'measurements': [{'value': '80', 'spread': '9', 'groupId': 'OG000'}, {'value': '81', 'spread': '10', 'groupId': 'OG001'}, {'value': '81', 'spread': '11', 'groupId': 'OG002'}]}]}, {'title': 'Week 16, N=58, 56, 58', 'categories': [{'measurements': [{'value': '78', 'spread': '9', 'groupId': 'OG000'}, {'value': '79', 'spread': '10', 'groupId': 'OG001'}, {'value': '76', 'spread': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 16', 'description': 'Values at baseline (Week 0) and at Week 16', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Systolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Week 0 (Baseline), N=60, 59, 62', 'categories': [{'measurements': [{'value': '134', 'spread': '15', 'groupId': 'OG000'}, {'value': '138', 'spread': '18', 'groupId': 'OG001'}, {'value': '137', 'spread': '18', 'groupId': 'OG002'}]}]}, {'title': 'Week 16, N=58, 56, 58', 'categories': [{'measurements': [{'value': '128', 'spread': '13', 'groupId': 'OG000'}, {'value': '135', 'spread': '17', 'groupId': 'OG001'}, {'value': '133', 'spread': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 16', 'description': 'Values at baseline (Week 0) and at Week 16', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'classes': [{'title': 'Week 0 (Baseline), N=60, 59, 62', 'categories': [{'measurements': [{'value': '74', 'spread': '10', 'groupId': 'OG000'}, {'value': '76', 'spread': '8', 'groupId': 'OG001'}, {'value': '75', 'spread': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week 16, N=58, 56, 58', 'categories': [{'measurements': [{'value': '73', 'spread': '10', 'groupId': 'OG000'}, {'value': '73', 'spread': '8', 'groupId': 'OG001'}, {'value': '77', 'spread': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 16', 'description': 'Values at baseline (Week 0) and at Week 16', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.'}, {'type': 'SECONDARY', 'title': 'Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG001', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'OG002', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'timeFrame': 'Week -4, Week 8, Week 16', 'description': 'Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'FG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'FG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'Exposed', 'achievements': [{'comment': 'One subject withdrew prior to exposure to trial drug', 'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The trial was conducted at 27 sites in 5 countries: Finland (4), France (4), Germany (6), Poland (9) and Spain (4).', 'preAssignmentDetails': 'Subjects underwent a run-in period of up to 3 weeks (including 1-week maintenance period) where metformin was up-titrated to 1500 or 2000 mg/day. Subjects who tolerated metformin dose for a week and had fasting plasma glucose ≥ 7.5 mmol/L were randomised to SIAC 30 (B), SIAC 45 (B) or BIAsp 30 twice daily.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SIAC 30 (B)', 'description': 'Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'BG001', 'title': 'SIAC 45 (B)', 'description': 'Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \\[1 dosing unit = 6 nmol\\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'BG002', 'title': 'BIAsp 30', 'description': 'Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '59.6', 'spread': '8.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '8.5', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '11.8', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '11.7', 'spread': '3.1', 'groupId': 'BG002'}, {'value': '11.6', 'spread': '2.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2009-11-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2008-01-30', 'dispFirstSubmitQcDate': '2009-11-09', 'resultsFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2008-01-30', 'dispFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-27', 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Haemoglobin (HbA1c)', 'timeFrame': 'Week 0, Week 16', 'description': 'Change from baseline in HbA1c after 16 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)', 'timeFrame': 'Week 16', 'description': 'Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.'}, {'measure': 'Rate of Major and Minor Hypoglycaemic Episodes', 'timeFrame': 'Week 0 to Week 16 + 5 days follow up', 'description': 'Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.'}, {'measure': 'Rate of Nocturnal Major and Minor Hypoglycaemic Episodes', 'timeFrame': 'Week 0 to Week 16 + 5 days follow up', 'description': 'Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).'}, {'measure': 'Rate of Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Week 0 to Week 16 + 5 days follow up', 'description': "Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect."}, {'measure': 'Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)', 'timeFrame': 'Week -4, Week 16', 'description': 'Laboratory values at screening (Week -4) and at Week 16'}, {'measure': 'Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)', 'timeFrame': 'Week -4, Week 16', 'description': 'Laboratory values at screening (Week -4) and at Week 16'}, {'measure': 'Laboratory Safety Parameters (Biochemistry): Serum Creatinine', 'timeFrame': 'Week -4, Week 16', 'description': 'Laboratory values at screening (Week -4) and at Week 16'}, {'measure': 'Vital Signs: Diastolic Blood Pressure (BP)', 'timeFrame': 'Week 0, Week 16', 'description': 'Values at baseline (Week 0) and at Week 16'}, {'measure': 'Vital Signs: Systolic Blood Pressure (BP)', 'timeFrame': 'Week 0, Week 16', 'description': 'Values at baseline (Week 0) and at Week 16'}, {'measure': 'Vital Signs: Pulse', 'timeFrame': 'Week 0, Week 16', 'description': 'Values at baseline (Week 0) and at Week 16'}, {'measure': 'Physical Examination', 'timeFrame': 'Week -4, Week 8, Week 16', 'description': 'Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22660026', 'type': 'RESULT', 'citation': 'Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Munoz-Torres M, Donnet JP, Endahl L, Skjoth TV, Vaag A. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012 Aug;167(2):287-94. doi: 10.1530/EJE-12-0293. Epub 2012 Jun 1.'}, {'pmid': '22946603', 'type': 'RESULT', 'citation': 'Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \\[SIAC\\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)\n* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)\n* Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)\n* HbA1c, 7.0-11.0 % (both inclusive)\n* Body Mass Index (BMI), 25.0-37.0 kg/m\\^2 (both inclusive)\n\nExclusion Criteria:\n\n* Metformin contraindication according to local practice\n* Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1\n* Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation\n* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product"}, 'identificationModule': {'nctId': 'NCT00613951', 'briefTitle': 'Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment', 'orgStudyIdInfo': {'id': 'NN5401-1792'}, 'secondaryIdInfos': [{'id': '2007-002462-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIAC 30 (B)', 'interventionNames': ['Drug: insulin degludec/insulin aspart', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'SIAC 45 (B)', 'interventionNames': ['Drug: insulin degludec/insulin aspart', 'Drug: metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BIAsp 30', 'interventionNames': ['Drug: biphasic insulin aspart', 'Drug: metformin']}], 'interventions': [{'name': 'insulin degludec/insulin aspart', 'type': 'DRUG', 'description': 'Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily', 'armGroupLabels': ['SIAC 30 (B)']}, {'name': 'insulin degludec/insulin aspart', 'type': 'DRUG', 'description': 'Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily', 'armGroupLabels': ['SIAC 45 (B)']}, {'name': 'biphasic insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme, injection s.c., twice daily', 'armGroupLabels': ['BIAsp 30']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Tablets, 1500-2000 mg/daily', 'armGroupLabels': ['BIAsp 30', 'SIAC 30 (B)', 'SIAC 45 (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00260', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '15110', 'city': 'Lahti', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}, {'zip': 'FI-28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 61.48072, 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