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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin glulisine; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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.