Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
|ClinicalTrials.gov Identifier: NCT00358124|
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: insulin glargine Drug: rosiglitazone Drug: metformin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2001|
|Estimated Study Completion Date :||June 2002|
- 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 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358124
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Karen Barch||Sanofi|