Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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).