GSK Halts Enrollment in Avandia Study at FDA Request


GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA  review of recommendations from its  Advisory Committee meeting July 13-14. Patients already enrolled may continue in the trial.

This post-marketing study is designed to examine the comparative cardiovascular safety of rosiglitazone (Avandia) and pioglitazone (Actos) in patients with type 2 diabetes. The study was mandated by the FDA and is being conducted by an independent academic research group, Population Health Research Institute based at McMaster University.

GSK will work with the TIDE Steering Committee to send a summary of recent safety data and a summary of the FDA Advisory Committee meeting on Avandia to all TIDE investigators and Institutional Review Boards to ensure they have the latest information for patients.

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee that the TIDE trial continue if Avandia remains available (20 yes, 10 no) will now be considered by the FDA in making its final decision on Avandia.  Pending that decision, Avandia remains available to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.


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