Insulin Glulisine in Type 2 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00310297
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Time to GLUmax (Tmax, min) during the study conduct Maximum plasma glucose concentration (GLUmax, mmol/L) During the Study Conduct Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L) during the study conduct
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax, μIU/mL) During the study conduct Time to maximum concentration (Tmax, min) During the study conduct Area under the insulin concentration-time curve after injection(μIU.min/mL) 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) Adverse events collection from the inform consnet signed up to the end of the study