Insulin Glulisine in Type 2 Diabetes Mellitus
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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.|
- Maximum plasma glucose concentration (GLUmax, mmol/L) [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]
- Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- Time to GLUmax (Tmax, min) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- Area under the insulin concentration-time curve after injection(μIU.min/mL) [ Time Frame: between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h) ] [ Designated as safety issue: No ]
- Maximum concentration (Cmax, μIU/mL) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Adverse events collection [ Time Frame: from the inform consnet signed up to the end of the study ] [ Designated as safety issue: No ]
- Time to maximum concentration (Tmax, min) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
|Study Start Date:||November 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310297
|Study Director:||Valérie Pilorget, MD||Sanofi|