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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00271284 |
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.
·Secondary objectives:
Efficacy:
Tolerance:
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Drug: insulin glulisine / insulin glargine Drug: insulin glulisin / insulin detemir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients |
Enrollment: | 88 |
Study Start Date: | October 2005 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental |
Drug: insulin glulisine / insulin glargine
insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
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II: Active Comparator |
Drug: insulin glulisin / insulin detemir
insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria :
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HMR1964A/3516, EudraCT #: 2005-002771-32 |
Study First Received: | December 29, 2005 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00271284 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Insulin glulisine Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |