drugset / Trial / NCT00310297
Insulin Glulisine in Type 2 Diabetes Mellitus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin glulisine | Protein / enzyme biologic | — | Subcutaneous |