| Trial ID: | L2009 |
| Source ID: | NCT00290927
|
| Associated Drug: |
Insulin Glulisine
|
| Title: |
Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin glulisine
|
| Outcome Measures: |
Primary: Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy)|Safety of HMR1964 | Secondary: change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy).
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
390
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-12
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2009-08-26
|
| Locations: |
Sanofi-Aventis, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00290927
|
