| Trial ID: | L4215 |
| Source ID: | NCT00358124
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: insulin glargine|DRUG: rosiglitazone|DRUG: metformin
|
| Outcome Measures: |
Primary: The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.|Other efficacy variables were the change from baseline in FPG, serum lipids and weight. | Secondary: Secondary efficacy parameters were: a mean change from baseline in FPG|Mean change from baseline in fasting insulin/C-peptide levels|Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)|Mean change from baseline for bodyweight.|Health-related quality of life was compared between the baseline visit and the follow-up assessments
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
220
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-01
|
| Completion Date: |
2002-06
|
| Results First Posted: |
|
| Last Update Posted: |
2011-01-11
|
| Locations: |
Sanofi-Aventis, Bridgewater, New Jersey, 08807, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00358124
|
