12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.
NCT00046150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2008-06-19
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
- Diabetes, Type I
Interventions
- DRUG
-
Insulin glulisine (HMR1964)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ICD CSD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-05-31
- Completion
- 2002-12-31
Countries
- France
- Germany
- Netherlands
Study Locations
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