In contrast, the ADVANCE study, has not shown any harm in its intensive treatment arm. In this trial, 11,140 high-risk patients with type 2 diabetes, were randomised to intensive (aiming for an HbA1C A1C level below 6.5) versus standard glucose lowering treatment. Patients in the intensive group started treatment with the sulphonylurea drug, gliclazide modified release, and then other drugs could be added.
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Chairman of the ADVANCE Data Monitoring and Safety Committee, Professor Rory Collins from the University of Oxford, said “The interim results from ADVANCE provide no confirmation of the adverse mortality trend reported from the ACCORD study”. He also noted that the ADVANCE interim results were based on more than twice as much data and similar levels of glucose control as in ACCORD.
ADVANCE principal investigator, Professor Stephen MacMahon (The George Institute for International Health in Sydney, Australia), stated that “Due to the unexpected report from the ACCORD trial, we felt it was in the public interest for us to ask our Data Monitoring and Safety Committee to make a statement as to whether the available data from ADVANCE provide any support for the suggestion that intensive blood glucose lowering may increase mortality”.
The ADVANCE investigators said the results are 99% complete, “so we are confident that the interim findings communicated here are a reliable guide to the final results”. Definitive results will be presented later this year.