Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

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).

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.