Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00283751
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2006-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in 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': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], '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': 583}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2006-01-27', 'studyFirstSubmitQcDate': '2006-01-27', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'after 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Insulin antibodies'}, {'measure': 'Incident of hypoglycaemic episodes and adverse events'}, {'measure': 'Plasma glucose profiles'}, {'measure': 'Change in body weight'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '18204830', 'type': 'RESULT', 'citation': 'Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes for more than 12 months, and no previous insulin treatment\n* Oral Antidiabetic Drug treatment for at least 4 months\n* Body Mass Index (BMI) less than 40 kg/m2\n* HbA1c 7.5-10.0%\n\nExclusion Criteria:\n\n* Current or previous treatment with thiazolidinediones within the last 6 months\n* Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months\n* Proliferative retinopathy or maculopathy\n* Known hypoglycaemia unawareness'}, 'identificationModule': {'nctId': 'NCT00283751', 'briefTitle': 'Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN304-1373'}}, 'armsInterventionsModule': {'interventions': [{'name': 'insulin detemir', 'type': 'DRUG'}, {'name': 'insulin glargine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68521', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08232', 'city': 'Pleasantville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.38984, 'lon': -74.52404}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29464', 'city': 'Mt. 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