Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 4:12 AM
Study NCT ID:
NCT00537303
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2007-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia']}, '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'}], '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'}]}}, '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 timeframe of 36 weeks.', 'description': 'Safety analysis set is all randomised subjects exposed to at least one dose of trial products.', 'eventGroups': [{'id': 'EG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.', 'otherNumAtRisk': 146, 'otherNumAffected': 54, 'seriousNumAtRisk': 146, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.', 'otherNumAtRisk': 150, 'otherNumAffected': 58, 'seriousNumAtRisk': 150, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lung Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetic Foot Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Duodenal Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholecystitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'OG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.67', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '7.61', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value for test of difference between treatments.', 'groupDescription': 'Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.', 'nonInferiorityComment': 'The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 36', 'description': 'Analysed for the full analysis set.', 'unitOfMeasure': 'percentage (%) of total haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.'}, {'type': 'PRIMARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'OG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.55', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.26', 'pValueComment': 'P-value for test of difference between treatments.', 'groupDescription': 'Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 36', 'description': 'Measured for the Per Protocol analysis set.', 'unitOfMeasure': 'percentage (%) of total haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'OG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '531', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms Only', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-36', 'description': 'Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.'}, {'type': 'SECONDARY', 'title': 'Biochemistry: Serum Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'OG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.09', 'spread': '18.54', 'groupId': 'OG000'}, {'value': '27.04', 'spread': '14.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 36', 'description': 'Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.'}, {'type': 'SECONDARY', 'title': 'Haematology: Haemoglobin Measured in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'OG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.57', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '8.58', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 36', 'description': 'Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'OG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.76', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '6.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 36', 'description': 'High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'FG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'A total of 67 centres in 12 countries participated: Denmark (1), Finland (6), France (5), Netherlands (6), Norway (5), Russian Federation (4), Serbia (2), South Africa (3), Spain (5), Sweden (3), United Kingdom (7), United States of America (20)', 'preAssignmentDetails': 'Eligible subjects were included in a 12-weeks forced titration period with insulin detemir as add-on to current oral anti-diabetic drug (OAD) treatment. Those subjects who did not meet the HbA1c target below 7% were then randomised to one of the two treatment regimens. Any use of sulphonylurea was discontinued at the time of randomisation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'BG001', 'title': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '8.29', 'groupId': 'BG000'}, {'value': '58.3', 'spread': 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'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '242', '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': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '0.10', 'groupId': 'BG000'}, {'value': '1.67', 'spread': '0.10', 'groupId': 'BG001'}, {'value': '1.68', 'spread': '0.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '88.8', 'spread': '15.8', 'groupId': 'BG000'}, 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'participants'}, {'title': 'HbA1c (glycosylated haemoglobin A1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.89', 'spread': '1.16', 'groupId': 'BG000'}, {'value': '8.67', 'spread': '0.97', 'groupId': 'BG001'}, {'value': '8.78', 'spread': '1.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage (%) of total haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes history', 'classes': [{'categories': [{'measurements': [{'value': '11.82', 'spread': '5.99', 'groupId': 'BG000'}, {'value': '12.68', 'spread': '6.68', 'groupId': 'BG001'}, {'value': '12.25', 'spread': '6.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years since diagnosis', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2007-09-28', 'resultsFirstSubmitDate': '2010-07-16', 'studyFirstSubmitQcDate': '2007-09-28', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-07-16', 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'week 36', 'description': 'Analysed for the full analysis set.'}, {'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'week 36', 'description': 'Measured for the Per Protocol analysis set.'}], 'secondaryOutcomes': [{'measure': 'Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-36', 'description': 'Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.'}, {'measure': 'Biochemistry: Serum Alanine Aminotransferase', 'timeFrame': 'week 36', 'description': 'Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.'}, {'measure': 'Haematology: Haemoglobin Measured in Blood', 'timeFrame': 'week 36', 'description': 'Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.'}, {'measure': 'Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide', 'timeFrame': 'week 36', 'description': 'High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '21550957', 'type': 'RESULT', 'citation': 'Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe, Africa and the United States of America (USA).\n\nThe aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus for more than 6 months\n* HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)\n* BMI (Body Mass Index) less than 40 kg/m2\n* Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)\n* Treatment with one to 3 OADs\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial products or related products\n* Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks\n* Previous participation in any trial including this for the last 6 months\n* Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)'}, 'identificationModule': {'nctId': 'NCT00537303', 'briefTitle': 'Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN304-1833'}, 'secondaryIdInfos': [{'id': '2007-000123-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Basic', 'description': 'Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. 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