Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT01388361
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2011-07-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
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': 'C571886', 'term': 'insulin degludec'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}]}}, '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': 'Treatment emergent adverse events were collected during 26 week treatment period + 7 days follow up.', 'description': 'The SAS included all subjects who received at least one dose of the investigational product or its comparator.', 'eventGroups': [{'id': 'EG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.", 'otherNumAtRisk': 236, 'otherNumAffected': 64, 'seriousNumAtRisk': 236, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.', 'otherNumAtRisk': 87, 'otherNumAffected': 40, 'seriousNumAtRisk': 87, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.', 'otherNumAtRisk': 86, 'otherNumAffected': 18, 'seriousNumAtRisk': 86, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 54, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glomerulonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms."}, {'id': 'OG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'OG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Values for change in HbA1c from baseline to 26 weeks of treatment period.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS and NAS included all randomised and non-randomised subjects respectively, and missing data was imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms."}, {'id': 'OG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'OG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.23', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '2.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Values for change in FPG in mmol/L from baseline to week 26 of randomised period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period. The FPG values were missing for 7 subjects in FAS (2 subjects with IDeg+ liraglutide; 5 subjects with IDeg+IAsp arm) and 10 subjects in NAS for IDeg arm at baseline. The missing data was imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms."}, {'id': 'OG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'OG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Corresponds to the values of change in body weight in kilograms from baseline to week 26.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period and missing data was imputed using LOCF. At baseline, the body weight values were missing for 1 subject in IDeg + Liraglutide arm from FAS and 3 subjects in NAS for IDeg arm.'}, {'type': 'SECONDARY', 'title': 'Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms."}, {'id': 'OG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'OG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}], 'classes': [{'title': 'Confirmed(severe+minor)', 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '330', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.', 'description': 'Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value \\< 3.1 mmol/L (56 mg/dL).', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms."}, {'id': 'FG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'FG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'Exposed', 'achievements': [{'comment': 'Two subjects withdrew prior to exposure to IDeg during NN1250-3948', 'groupId': 'FG000', 'numSubjects': '234'}, {'comment': 'One subject withdrew prior to exposure to trial drug.', 'groupId': 'FG001', 'numSubjects': '87'}, {'comment': 'Three subjects withdrew prior to exposure to trial drug.', 'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 119 sites in 12 countries: Austria (4), Belgium (4), Canada (15), Czech Republic (4), Denmark (6), Finland (6), France (4), Germany (12), Norway (6), Serbia (5), Spain (7) and United States (46). These sites enrolled subjects in the randomised or non-randomised arms of the trial.', 'preAssignmentDetails': 'Subjects treated with Insulin degludec (IDeg) once daily (OD) + metformin in trial NN1250-3643 (NCT01193309) were eligible for this trial. Eligible subjects with an HbA1c \\>/=7.0% at the end of 3643 trial were qualified to enter the extension trial 3948 and be randomised to add either liraglutide/insulin aspart to their prior IDeg + Met treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '413', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IDeg', 'description': "This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \\< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms."}, {'id': 'BG001', 'title': 'IDeg + Liraglutide', 'description': 'All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'BG002', 'title': 'IDeg + IAsp OD', 'description': 'Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '9.3', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG002'}, {'value': '61.9', 'spread': '9.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Non-randomised population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the previous row, baseline values for non-randomised arm IDeg.', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '61.0', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Randomised population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Non-randomised population.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Values available in the previous row, baseline values for non-randomised arm IDeg.', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Values available in the previous row, baseline values for non-randomised arm IDeg.', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomised population.', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '0.4', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG002'}, {'value': '6.4', 'spread': '0.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Non-randomised population.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the previous row, baseline values for non-randomised arm IDeg.', 'groupId': 'BG000'}, {'value': '7.7', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Randomised population.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '1.8', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the next row, baseline values for IDeg + Liraglutide vs. IDeg + IAsp OD.', 'groupId': 'BG002'}, {'value': '6.7', 'spread': '1.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Non-randomised population.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values available in the previous row, baseline values for non-randomised arm IDeg.', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '6.1', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '6.3', 'spread': '2.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Randomised population.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The full analysis set (FAS) included all randomised patients except for 7 subjects (2 subjects with IDeg+ liraglutide; 5 subjects with IDeg+IAsp arm) fasting plasma glucose (FPG) values were missing at baseline. Non-randomised set (NAS) included all non-randomised subjects, the FPG values were missing for 10 subjects at baseline.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2013-11-28', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2011-07-04', 'dispFirstSubmitQcDate': '2013-11-28', 'resultsFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2011-07-04', 'dispFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-23', 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)', 'timeFrame': 'week 0, week 26', 'description': 'Values for change in HbA1c from baseline to 26 weeks of treatment period.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'timeFrame': 'week 0, week 26', 'description': 'Values for change in FPG in mmol/L from baseline to week 26 of randomised period.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'week 0, week 26', 'description': 'Corresponds to the values of change in body weight in kilograms from baseline to week 26.'}, {'measure': 'Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes', 'timeFrame': 'Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.', 'description': 'Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value \\< 3.1 mmol/L (56 mg/dL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '24443830', 'type': 'RESULT', 'citation': 'Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Ocampo Francisco AM, Rana A, Zinman B; BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jul;16(7):636-44. doi: 10.1111/dom.12262. Epub 2014 Feb 11.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.\n\nEligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], '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* The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.\n* Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol\n\nExclusion Criteria:\n\n* Participated in NN1250-3643 and treated with insulin glargine\n* Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)\n* Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643\n* Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin \\[For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \\& Gault formula\\] at end of treatment in NN1250-3643.'}, 'identificationModule': {'nctId': 'NCT01388361', 'acronym': 'BEGIN™', 'briefTitle': 'Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)', 'orgStudyIdInfo': {'id': 'NN1250-3948'}, 'secondaryIdInfos': [{'id': '2011-001493-25', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1120-2782', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDeg (non-randomised)', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'IDeg + IAsp', 'interventionNames': ['Drug: insulin degludec', 'Drug: insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'IDeg + liraglutide', 'interventionNames': ['Drug: insulin degludec', 'Drug: liraglutide']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Injected s.c. (under the skin) once daily. The doses will be individually adjusted', 'armGroupLabels': ['IDeg (non-randomised)', 'IDeg + IAsp', 'IDeg + liraglutide']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Injected s.c. (under the skin) once daily. The doses will be individually adjusted.', 'armGroupLabels': ['IDeg + IAsp']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Injected s.c. (under the skin) once daily. The doses will be individually adjusted.', 'armGroupLabels': ['IDeg + liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520-1926', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '91356-3551', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': 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'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 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