RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week
run-in period will be followed by a median of 6 years of treatment with study medication in
addition to continuation of background glucose lowering therapy. Patients inadequately
controlled on background metformin will be randomised to receive, in addition to metformin,
either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio
of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in
addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of
patients receiving background metformin and SU at entry will be entered into the study.