Blinded, Re-adjudication of Mortality and Major Cardiovascular Endpoints (MACE) from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of glycaemia in Diabetes trial (RECORD)RECORD

Trial description: This study will independently re-adjudicate and re-analyze mortality and major adverse cardiovascular events (MACE) reported during the RECORD trial. The RECORD trial was an open-label, randomized trial comparing rosiglitazone-containing combination therapy for type 2 diabetes with the most commonly used dual oral combination of metformin and a sulfonylurea. The results of the RECORD study [NCT00379769] together with other data were reviewed and discussed at a July 13-14, 2010 joint meeting of the Food and Drug Administration’s (FDA) Endocrinology and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Following the review, the FDA required GSK to commission an independent, patient record level, re-adjudication of all cause deaths and deaths due to cardiovascular reasons, as well as non-fatal myocardial infarction and non fatal stroke. This will be conducted in a stepwise manner with initial examination of the mortality finding; if the mortality finding is determined to be valid by the FDA, then the other MACE elements will be adjudicated.