Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-04-13 @ 5:40 PM
Study NCT ID:
NCT00537251
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2007-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-28', 'studyFirstSubmitDate': '2007-09-28', 'studyFirstSubmitQcDate': '2007-09-28', 'lastUpdatePostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c .', 'timeFrame': 'after 16 weeks of treatment with each treatment regime'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.', 'detailedDescription': 'Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:\n\n* Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)\n* Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with type 1 diabetes mellitus\n* 18-65 years of age\n* C-Peptide negative\n* Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m².\n* Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.'}, 'identificationModule': {'nctId': 'NCT00537251', 'briefTitle': '32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.', 'orgStudyIdInfo': {'id': 'HOE901_4023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Insulin glargine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jose Taboada Mosquera', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}