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

NCT01159353

Phase 1 Completed 37 enrolled Sanofi
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

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Subject insulin aspart Protein / enzyme biologic 0.2 iu/kg Subcutaneous