NIDDK Discontinues Troglitazone Arm of "Diabetes Prevention Program" Clinical Trial
June 4, 1998
The National Institute of Diabetes and Digestive and Kidney Diseases has discontinued the study of troglitazone to prevent type 2 diabetes in people with impaired glucose tolerance following the recommendation of the Data Monitoring Board for the Diabetes Prevention Program (DPP). Troglitazone (Rezulin) is FDA approved for the treatment of type 2 diabetes but was being studied in the DPP as a potential preventive measure in people with impaired glucose tolerance, who are at high risk for developing type 2 diabetes. The Institute action pertains only to the Diabetes Prevention Program clinical trial of people who do not yet have diabetes and does not pertain to patients with clinical diabetes who are under treatment for control of elevated blood glucose levels.
One of the 585 recipients of troglitazone in the DPP, a multi-center controlled clinical trial, died on May 17 following liver failure and a liver transplant. The clinical course and ultimate death of the patient were complex. However, a three member panel of experts concluded that drug induced liver toxicity was probably the cause of liver failure. Largely in view of this report and because the DPP is a prevention study, the Board recommended to the Institute discontinuation of the troglitazone arm of the study.
The study had four arms: troglitazone, 2 lifestyle interventions, and metformin, another drug approved for the treatment of type 2 diabetes, but with a different mechanism of action from troglitazone. The other arms of the study will continue. Recruitment is about 50 per cent complete, with a total of 2,395 participants in the entire study.
NIDDK is notifying the principal investigators in all 26 DPP centers to discontinue administration of troglitazone. The principal investigators are being asked to notify all 585 troglitazone recipients by telephone to stop taking the drug. The DPP is also notifying recipients by registered letter. All participants in this arm of the study will be told whether they were taking troglitizone or a placebo.
Participants will be asked to come to their respective centers and return unused pills. The people taking troglitazone will be given the opportunity to be followed for diabetes by the study group. The decision to end the troglitazone arm of the study will also be conveyed to the total number of people who have been recruited to the study, regardless of the treatment they have been assigned.
The Food and Drug Administration was notified of the death, and later notified that NIDDK has decided to end the study of troglitazone in patients who are at risk for developing diabetes but do not yet have diabetes.
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