Type 2 Diabetes Mellitus
Conditions
Brief summary
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
Detailed description
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).
Interventions
DRUGInsulin glulisine
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
DRUGInsulin aspart
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
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients with type 2 diabetes for at least one year * treated with oral antidiabetic agents (OADs) for at least 6 months * Baseline C-peptide ≥0.1 nmol/L * BMI (body mass index) between 30 and 40 kg/m2 * HbA1c (glycosylated hemoglobin) \< 8.5% * signed informed consent
Exclusion criteria
* type I diabetes mellitus * current treatment with insulin * pregnant and breast-feeding women * any medication known to influence insulin sensitivity * current treatment with systemic corticosteroids * history of acute metabolic complications in the past 3 months * recurrent severe hypoglycaemia or hypoglycaemic unawareness * active proliferative diabetic retinopathy and known diabetic gastroparesis * impaired hepatic function, as shown but not limited to ALT or AST above 2 times the upper limit of normal * clinically relevant illness such as nephropathy and impaired renal function as shown by clearance \< 30 ml/min * any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult * hypersensitivity to insulins or insulin analogs The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h) | At day 1 of each treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma insulin concentration curve AUC (0-2h) | At day 1 of each treatment period |
| Area under the plasma insulin concentration curve AUC (0-4h) | At day 1 of each treatment period |
| Area under the plasma insulin concentration curve AUC (0-6h) | At day 1 of each treatment period |
| Area under the curve of plasma glucose concentration AUC(0-2h) | At day 1 of each treatment period |
| Area under the curve of plasma glucose concentration AUC(0-4h) | At day 1 of each treatment period |
| Area under the curve of plasma glucose concentration AUC(0-6h) | At day 1 of each treatment period |
| Delta plasma glucose at 1h after standard meal | At day 1 of each treatment period |
| Maximum insulin concentration (Cmax) | At day 1 of each treatment period |
| Maximum glucose excursion (delta GLU max) | At day 1 of each treatment period |
| Time to delta GLU max | At day 1 of each treatment period |
| Time to fraction of total glucose AUC(10%, 20%) | At day 1 of each treatment period |
| Area under the plasma insulin concentration curve AUC (0-1h) | At day 1 of each treatment period |
| Time to fraction of total insulin AUC (10%, 20%) | At day 1 of each treatment period |
| Time to Cmax | At day 1 of each treatment period |
| Hypoglycaemia and adverse events | from randomization to the end of study |
| Maximum glucose concentration (GLU max) | At day 1 of each treatment period |
Countries
France
Outcome results
None listed