Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
NCT00290927 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390
Last updated 2009-08-26
Summary
* To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
* To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
* To evaluate the safety of HMR1964.
Conditions
- Diabetes Mellitus, Type 2
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
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
Countries
- Japan
Study Locations
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