Primary Objective: * To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes. Secondary Objectives: Pharmacodynamic objectives: * To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart. Pharmacokinetic objective: * To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups Safety objective: * To assess the safety of insulin glulisine in comparison to insulin aspart
Duration of treatment: two study days separated by a 7-day wash-out period Duration of observation: * screening period of 1-2 weeks, \>2 study days (with a wash-out period of 7 days between the study days), * Follow-up visit (within 2 weeks after the end of the study treatment period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
Sanofi-Aventis Administrative Office
Paris, France
Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)
Time frame: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-2h)
Time frame: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-4h)
Time frame: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-6h)
Time frame: At day 1 of each treatment period
Delta plasma glucose at 1h after standard meal
Time frame: At day 1 of each treatment period
Maximum glucose concentration (GLU max)
Time frame: At day 1 of each treatment period
Maximum glucose excursion (delta GLU max)
Time frame: At day 1 of each treatment period
Time to delta GLU max
Time frame: At day 1 of each treatment period
Time to fraction of total glucose AUC(10%, 20%)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-1h)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-2h)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-4h)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-6h)
Time frame: At day 1 of each treatment period
Maximum insulin concentration (Cmax)
Time frame: At day 1 of each treatment period
Time to fraction of total insulin AUC (10%, 20%)
Time frame: At day 1 of each treatment period
Time to Cmax
Time frame: At day 1 of each treatment period
Hypoglycaemia and adverse events
Time frame: from randomization to the end of study
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