Comparison of the Efficacy and Tolerability of the Addition of AVANDIA to Submaximal Doses of Metformin

Summary

This was a randomized, double-blind, double dummy, multicenter study to assess the safety, efficacy and tolerability of the addition of RSG (rosiglitazone) to sub-maximal MET (metformin) combination relative to maximal MET monotherapy in subjects with type 2 DM (diabetes mellitus). The total duration of the study was approximately 20 months. The study consisted of a two-week washout period, a four to seven-week MET titration period, and a 24-week randomized treatment phase in which subjects, stratified by prior therapy, received either RSG + MET combination therapy or MET monotherapy.

Timeline

Start

2001-06-05

Primary completion

2003-02-13

Completion

2003-02-13

Publications

• Results Goldstein BJ, Cobitz AR, Hand LM, Chen H. Are the metabolic effects of rosiglitazone influenced by baseline glycaemic control? Curr Med Res Opin. 2003;19(3):192-9. doi: 10.1185/030079903125001695.
• Results Rosenstock J, Goldstein BJ, Wooddell MJ, Strow LJ, Waterhouse BR, Cobitz AR Greater benefits of rosiglitazone added to submaximal dose of metformin compared to maximizing metformin dose in type 2 diabetes mellitus patients. Diabetes 2004; 53 (Suppl 2): A144 Poster presented at ADA
• Results Weissman PW, Goldstein BJ, Campbell JC, Gould ER, Waterhouse BR, Strow LJ, Cobitz AR. Rosiglitazone plus metformin combination effects on CV risk markers suggest potential CV benefits in type 2 diabetes patients. Diabetes 2004;53(Suppl 2): A28 Oral presentation at ADA

Drugs

Indications