drugset / Trial / NCT00499707
Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
Timeline
- Start
- 2003-10-08
- Primary completion
- 2004-12-01
- Completion
- 2004-12-16
Publications
- Results Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | — | — |
| Subject | Rosiglitazone | Small molecule | — | — |