drugset / Trial / NCT00310297

Insulin Glulisine in Type 2 Diabetes Mellitus

NCT00310297

Phase 1 Completed Sanofi
RandomizedCrossoverOpen-labelTreatment

Summary

Primary objective: To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes. Secondary objectives: * To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day. * The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.

Timeline

Start
2004-11
Primary completion
2004-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous