Metformin Add-on Drops Fasting Glucose Levels by 12 Points in Phase 2 Trial

CRx-401, an insulin sensitizer intended to assist metformin in type 2 diabetes therapy, has successfully completed a Phase 2 clinical trial in which patients taking it saw their fasting plasma glucose drop by 12 mg/dl after 90 days.

Manufactured by Massachusetts-based CombinatoRx Inc., CRx-401 is a combination of bezafibrate and diflunisal that acts to control glucose, lipids, and inflammation. Bezafibrate is an anti-cholesterol agent, while diflunisal is an analgesic salicylate derivative related to aspirin.

The study was intended to prove that bezafibrate in combination with diflunisal is more effective than bezafibrate alone in reducing fasting blood glucose levels. It tracked 120 metformin-taking type 2 patients whose disease was poorly controlled by that drug alone. (Patients who were taking statins and low-dose aspirin before the study remained on them throughout.)

While all patients continued with their metformin therapy, half received daily doses of CRx-401, in a combination of 400 mg of sustained release bezafibrate and 250 mg of diflunisal. The other half received 400 mg of sustained release bezafibrate and a placebo.

Researchers were looking for positive effects on fasting glucose, A1c’s, cholesterol, triglycerides, and insulin resistance.

CombinatoRx president and CEO Alexis Borisy said that the results of the Phase 2 study have encouraged his company to continue testing and evaluating CRx-401 as an eventually marketable diabetes therapy.

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