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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00537251 |
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.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Drug: Insulin glargine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Enrollment: | 80 |
Study Start Date: | November 2001 |
Study Completion Date: | February 2004 |
Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | HOE901_4023 |
Study First Received: | September 28, 2007 |
Last Updated: | September 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00537251 History of Changes |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Metabolic Diseases Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Insulin LISPRO Diabetes Mellitus Type 1 Insulin |
Insulin, Isophane Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Autoimmune Diseases Immune System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Insulin |
Insulin, Isophane Pharmacologic Actions Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Glucose Metabolism Disorders |