Ergoset bromocriptine tablets data

ERGO reported that Phase III findings have demonstrated efficacy of Ergoset in obese adults with Type II diabetes who also are taking sulfonylurea agents to control the condition. Ergoset improved control of glucose, triglycerides, cholesterol, and free fatty acids in the 24-week study. Based on the results, ERGO expects to file an NDA in 1997.

The drug was well tolerated at a single daily dose of up to 4.8 mg, with side effects of nausea and dizziness that resolved. Withdrawal rate was 12 percent for the active agent, compared to 2 percent for placebo. A total of 398 patients completed the two trials (247 and 249 enrolled in the two trials respectively, with 199 completing each). ...