Warner-Lambert Company plans to initiate a five-year study to investigate the potential of Rezulin (troglitazone) to delay or prevent the progression of impaired glucose tolerance to type 2 diabetes.
"We are pleased the U.S. Food and Drug Administration has agreed to our proceeding with this important study," said Warner-Lambert president Lodewijk J.R. de Vink.
The study will examine the effects of Rezulin in 1,000 patients with impaired glucose tolerance. It will be conducted at more than 100 sites and is expected to begin early next year.
In June, the National Institute of Diabetes and Digestive and Kidney Diseases announced it had stopped the troglitazone treatment arm of its Diabetes Prevention Program after one of 585 study participants developed liver failure, required a liver transplant, and died. Rezulin was approved by the FDA in the United States December 1996 and was banned in Britain a year later.
In a press release issued by Warner-Lambert on November 20, the company said that because "Rezulin has been associated with serious liver problems which are usually reversible ... Rezulin patients should be monitored regularly for liver function."
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