·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: * 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. Tolerance: * To record undesirable events * To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
Sanofi-Aventis Administrative Office
Paris, France
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
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