Trials / Completed
CompletedNCT00046150
12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.
12-Week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing the Safety of HMR1964 and Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion (CSII) in Subjects With Type 1 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin glulisine (HMR1964) |
Timeline
- Start date
- 2002-05-01
- Completion
- 2002-12-01
- First posted
- 2002-09-23
- Last updated
- 2008-06-19
Locations
3 sites across 3 countries: France, Germany, Netherlands
Source: ClinicalTrials.gov record NCT00046150. Inclusion in this directory is not an endorsement.