Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
NCT00290979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2009-08-26
Summary
* To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.
* To compare the safety of HMR1964 with insulin lispro.
Conditions
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
insulin glulisine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Masayoshi KOYAMA · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
Countries
- Japan
Study Locations
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