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www.fdanews.com/articles/97219-combinatorx-announces-phase-iia-study-with-crx-401-for-type-2-diabetes

CombinatoRx Announces Phase IIa Study With CRx-401 for Type 2 Diabetes

August 15, 2007

CombinatoRx has dosed the first patient in a Phase IIa proof-of-concept clinical trial with CRx-401 in Type 2 diabetes.

According to CombinatoRx, CRx-401 is a novel insulin sensitizer designed to provide antidiabetic activity without promoting weight gain.

The trial is a multicenter, randomized study evaluating the safety and efficacy of CRx-401 (400 mg bezafibrate sustained release and 250 mg diflunisal), as an add-on therapy in Type 2 diabetes, compared with bezafibrate alone, the company said.

Approximately 80 subjects with Type 2 diabetes who are poorly controlled on metformin will be enrolled in the trial. Patients will be randomized to CRx-401 or 400 mg of bezafibrate sustained release plus placebo, the company added.