April 24, 2009
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Voglibose reduced the risk for type 2 diabetes in people with IGT

Voglibose, an alpha glucosidase inhibitor, in combination with lifestyle changes, reduced the risk for type 2 diabetes in a group of high-risk Japanese patients with impaired glucose tolerance.

Researchers randomly assigned 1,780 patients with IGT to either oral voglibose 0.2 mg three times daily (n=897) or placebo (n=883). Treatment continued until patients were diagnosed with type 2 diabetes, had normoglycemia or for at least three years.

Interim analysis including data between October 2006 and March 2007 identified 84 cases of type 2 diabetes in the placebo group and 40 cases in the treatment group (HR=0.577; 95% CI, 0.404-0.825). Based on these data, the Independent Data Monitoring Committee decided to terminate the study early.

In the final analysis, which included data gathered up to the time of termination, mean duration of treatment was 48.1 weeks. Fifty of 897 patients in the treatment group were diagnosed with type 2 diabetes vs. 106 of 881 patients in the placebo group (HR=0.595; 95% CI, 0.433-0.818). Patients in the treatment group had a 40.5% lower risk for developing type 2 diabetes when compared with patients in the placebo group.

Cumulative progression to type 2 diabetes was 9.4% among the placebo group vs. 3.6% among the voglibose group after 48 weeks. The corresponding rates after 96 weeks were 23.5% vs. 12.1% and rates after 144 weeks were 36.2% vs. 30.2%.

“Why the independent data-monitoring committee decided to end the voglibose study early is not known,” Andre J. Scheen, MD, PhD, of Belgium’s University of Liege, wrote in an accompanying editorial. “One might be able to understand such a decision when the primary endpoint included major adverse cardiovascular events or mortality but not when (as here) the endpoint is transition from IGT to diabetes. This decision led to a much shorter follow-up (<1 year) in this study than in other trials. Whether these preventive approaches can slow the development of vascular complications of diabetes and ultimately reduce diabetes-related mortality remains an open question.”

Kawamori R. Lancet. 2009;doi:10.1016/S0140-6736(09)60222-1.

Scheen AJ. Lancet. 2009;doi:10.1016/S0140-6736(09)60575-4.