Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients (VARIABILITE)
·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.
- To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
- To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
- To compare the glycaemic profiles (7 points)
- To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.
- To record undesirable events
- To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).
|Diabetes Mellitus, Type 1||Drug: insulin glulisine / insulin glargine Drug: insulin glulisin / insulin detemir||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy data : fasting blood glucose concentration [ Time Frame: read daily during the last 2 months of each period ]
- Tolerance data : undesirable events including episodes of hypoglycaemia [ Time Frame: throughout the study ]
|Study Start Date:||October 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Drug: insulin glulisine / insulin glargine
insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
|Active Comparator: II||
Drug: insulin glulisin / insulin detemir
insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271284
|Sanofi-Aventis Administrative Office|
|Study Director:||Marie SEBILLE, Dr||Sanofi|