An overview of the safety and tolerance of glimepiride.

The objective of this paper is to obtain an overview of the safety and tolerance of glimepiride by presenting results from the clinical trials in patients with non-insulin-dependent diabetes mellitus that were conducted during the development of this new product. A total of 21 clinical studies with a minimum duration of two weeks were conducted during the clinical development of glimepiride in the United States and Europe. This included four placebo-controlled, four active-controlled (with glyburide and glipizide), and three noncomparative trials conducted in the United States and 10 European studies (eight active controlled and two non-comparative). All of the patients provided an extensive medial history which included information on concomitant medications, underlying diseases, and ongoing adverse events. During the clinical studies, the patients were monitored for treatment-emergent signs and symptoms (TESS), clinical laboratory abnormalities, discontinuations, deaths, and serious adverse events. Over 6,500 patients were included in the worldwide clinical trials with more than 4,200 of these patients treated with glimeplride; 1,500 of these patients were treated for at least 1 year. In controlled clinical trials in the United States, 2,013 subjects received glimepiride, 294 placebo, 322 glyburide, and 258 glipizide. In European studies, the duration of therapy ranged from 14 days to 2.8 years in the 1,489 patients who received glimepiride and the 1,247 control patients who were treated with either glyburide or gliclazide. In the japanese studies, a total of 983 patients were treated, 718 on glimepiride.