drugset / Trial / NCT00499707

Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

NCT00499707

Phase 3 Completed 453 enrolled GlaxoSmithKline
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

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule
Subject Rosiglitazone Small molecule