Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients

Summary

·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).

Timeline

Start

2005-10

Primary completion

2008-09

Completion

2008-09

Publications

• Renard E, Dubois-Laforgue D, Guerci B; Variability Study Group. Non-inferiority of insulin glargine versus insulin detemir on blood glucose variability in type 1 diabetes patients: a multicenter, randomized, crossover study. Diabetes Technol Ther. 2011 Dec;13(12):1213-8. doi: 10.1089/dia.2011.0063. Epub 2011 Aug 2.

Drugs

Indications