Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
Study NCT ID:
NCT01562561
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2012-03-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C072379', 'term': 'repaglinide'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2002-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c (glycosylated haemoglobin)', 'timeFrame': 'Week 0 (visit 5); week 26'}], 'secondaryOutcomes': [{'measure': 'FPG (fasting plasma glucose)', 'timeFrame': 'Week 0 (visit 5); week 26'}, {'measure': '7-point blood glucose profile', 'timeFrame': 'Week 0 (visit 5); week 26'}, {'measure': 'Hypoglycaemic episodes', 'timeFrame': 'Week 0 (visit 5); week 26'}, {'measure': 'Adverse events', 'timeFrame': 'Week 0 (Visit 5); week 26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '15983336', 'type': 'RESULT', 'citation': 'Panelo A, Wing JR; AGEE-1272 Study Group. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. doi: 10.2337/diacare.28.7.1789. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)\n* BMI (body mass index) maximum 35 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT01562561', 'briefTitle': 'Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin', 'orgStudyIdInfo': {'id': 'AGEE-1272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rep + NPH', 'interventionNames': ['Drug: repaglinide', 'Drug: insulin NPH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NPH', 'interventionNames': ['Drug: insulin NPH']}], 'interventions': [{'name': 'repaglinide', 'type': 'DRUG', 'description': '2 mg at each main meal', 'armGroupLabels': ['Rep + NPH']}, {'name': 'insulin NPH', 'type': 'DRUG', 'description': 'Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.', 'armGroupLabels': ['NPH', 'Rep + NPH']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '16150', 'city': 'Kota Bharu, Kelantan', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}, {'zip': '1800', 'city': 'Marikina City', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6481, 'lon': 121.1133}}, {'zip': '1605', 'city': 'Pasig', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'zip': '1100', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '7460', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '1449', 'city': 'Alberton', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.26786, 'lon': 28.12225}}, {'zip': '710', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}