NCT00501020

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

Completed Phase 4 Last updated 9 October 2017

What this trial tests

Phase 4 trial testing Rosiglitazone in Diabetes Mellitus, Type 2 in 750 participants. Completed in 13 February 2003.

Timeline

5 June 2001

Primary endpoint
13 February 2003

13 February 2003

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	750
Start date	5 June 2001
Primary completion	13 February 2003
Estimated completion	13 February 2003

Drugs / interventions tested

• Rosiglitazone (ROSIGLITAZONE) — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.