RECORD.

Trial name or title	Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD)
Methods
Participants	RECORD is a 6‐year, randomised, open‐label study in type 2 diabetic patients with inadequate blood glucose control (HbA1c 7.1‐9.0%) on metformin or sulphonylurea alone.
Interventions	after a 4‐week run‐in, participants are randomised by current treatment stratum to add‐on rosiglitazone, metformin or sulphonylurea, with dose titration to a target HbA1c of <=7.0%; if confirmed HbA1c rises to >= 8.5%, either a third glucose‐lowering drug is added (rosiglitazone‐treated group) or insulin is started (non‐rosiglitazone group); the same criterion for failure of triple oral drug therapy in the rosiglitazone‐treated group is used for starting insulin in this group
Outcomes	the primary endpoint is the time to first cardiovascular hospitalisation or death, blindly adjudicated by a central endpoints committee; the study aim is to evaluate non‐inferiority of the rosiglitazone group versus the non‐rosiglitazone group with respect to cardiovascular outcomes; safety, tolerability and study conduct are monitored by an independent board
Starting date	recruitment began in April 2001 and was completed in April 2003
Contact information	P. D. Home School of Clinical Medical Sciences‐Diabetes, University of Newcastle upon Tyne, Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK E‐mail: philip.home@newcastle.ac.uk Tel.: +44‐191‐2227019 Fax: +44‐191‐2220723
Notes	study design and protocol published in Diabetologia 2005;48: 1726–35