drugset / Trial / NCT01159353
Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
RandomizedCrossoverDouble-blindTreatment
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
Timeline
- Start
- 2007-09
- Primary completion
- 2008-04
- Completion
- 2008-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin glulisine | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |
| Subject | insulin aspart | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |