| Trial ID: | L6474 |
| Source ID: | NCT00135083
|
| Associated Drug: |
Insulin Glulisine
|
| Title: |
Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin glulisine
|
| Outcome Measures: |
Primary: To show non-inferiority between treatment groups (insulin glargine plus insulin glulisine administered once a day, twice a day, or 3 times a day) in the change in glycemic control as measured by hemoglobin A1C., From baseline to study week 24. |
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
347
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-08
|
| Completion Date: |
2007-11
|
| Results First Posted: |
|
| Last Update Posted: |
2011-01-11
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00135083
|