GLASGOW, SCOTLAND — Data from the intensive glucose-lowering arm of the ADVANCE trial will be released earlier than expected, during the American Diabetes Association's 68th Annual Scientific Sessions in June.
Study investigator Dr. Neil R. Poulter of the National Heart and Lung Institute at Imperial College London, made the announcement during the annual professional conference of Diabetes U.K. The results had been planned for release at the European Association for the Study of Diabetes in September.
Only data from the intensive glucose-lowering arm of ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation) will be released, and these data follow as a direct result of the recent closure of the intensive glucose-lowering arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial.
Dr. Poulter said that the press statement issued by the data safety monitoring board for the ADVANCE trial still stood and that there was no evidence of increased cardiovascular mortality in patients treated with an intensive glucose-lowering regimen as there had been in ACCORD. At the time this statement was released, the data analyses were 99% complete, so there is unlikely to be any change, he said.
“In terms of statistical robustness, ADVANCE is more powerful; it's got about twice as much patient years of follow-up as ACCORD does,” Dr. Poulter said. Commenting on the differences between the trials, and what they may mean, he added, “The difference in insulin use was really quite dramatic between the two [trials].”
Dr. Poulter is a member of the management committee and director of the north European region of the ADVANCE study.