The FDA has informed GlaxoSmithKline (GSK), the manufacturer of the diabetes drug rosiglitazone (Avandia), that the postmarketing trial TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) has been placed on partial clinical hold.
Under the hold, no new patients may be enrolled into the trial until further notice from the FDA. However, patients already enrolled in the trial will be allowed to continue to participate.
This study seeks to answer two separate questions. The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.
The second question will compare the effects of long-term supplementation of vitamin D on death and cancer
The agency also instructed GSK to update investigators, institutional review boards and ethics committees involved in the TIDE trial regarding new safety information presented at the FDA's joint Advisory Committee meeting held last week, along with information regarding the deliberations and votes of that meeting.
The FDA said it is evaluating available information on Avandia's safety and the discussions of the recent advisory committee meeting. The FDA will update the public on the outcome of its review and its implications for Avandia and the TIDE trial when the review is complete.