12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.
Phase 3
Completed
- Conditions
- Diabetes, Type I
- Registration Number
- NCT00046150
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Frequency of catheter occlusions
- Secondary Outcome Measures
Name Time Method Unexplained hyperglycemia, parameters of glycemic control
Trial Locations
- Locations (2)
Sanofi-aventis Administrative Office
🇳🇱Gouda, Netherlands
Hospital de Rangueil
🇫🇷Toulouse, France