Dose-Exposure-Response in Type 1 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type I
- Registration Number
- NCT00368394
- Lead Sponsor
- Sanofi
- Brief Summary
To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
- Type 1 diabetes mellitus
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Outcome measures: Glucose infusion rate, insulin concentrations. Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇩🇪Neuss, Germany