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 (VARIABILITE)

NCT00271284 Phase 3 COMPLETED

·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).

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	88
Start date	2005-10
Completion	2008-09

Conditions

• Diabetes Mellitus, Type 1

Interventions

• insulin glulisine / insulin glargine
• insulin glulisin / insulin detemir

Primary outcomes

• Efficacy data : fasting blood glucose concentration — read daily during the last 2 months of each period

Countries

France