Vivus initiates extension study for diabetes

The OB-202 study is a 28 week, randomized, double blind, placebo controlled, efficacy and safety study of Qnexa in the glycemic management of obese type 2 diabetics. The newly initiated study, DM-230, will allow subjects to continue, in a blinded fashion as randomized, in the study for an additional 28 weeks.

The primary endpoint of the studies will be improvement of glycemic control as measured by a reduction of glycosylated hemoglobin (HbA1c) levels. The randomized, double-blind, parallel-designed study will also measure the effects of Qnexa on associated metabolic and cardiovascular risk factors as well as changes in total body weight, percent of baseline body weight lost, and a change in waist circumference. The OB-202 study will measure endpoints at the end of 28 weeks. The DM-230 study will measure endpoints after an additional 28 weeks (for a total time on treatment of one year).

Both studies are intended to assess both safety and efficacy of Qnexa in subjects with type 2 diabetes controlled with diet or oral medications. Vivus has enrolled 210 subjects in the OB-202 study. As subjects complete the first 28 weeks of treatment they will roll over into the DM-230 study.

Peter Tam, senior vice president of product and corporate development at Vivus, said: “The extension study, DM-230, will allow us to see the impact of Qnexa for a full year of treatment on diabetes as a whole.”