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news.CombinatoRx has dosed the first patient in a Phase IIa proof of concept clinical trial in type 2 diabetes with CRx-401, a novel insulin sensitizer designed to provide anti-diabetic activity without promoting weight gain.
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CombinatoRx says it selected CRx-401 for clinical evaluation based on preclinical data demonstrating decreased fasting glucose and insulin resistance without weight gain.
According to the company, CRx-401 offers the potential to achieve and maintain multiple treatment goals including reducing hyperglycemia, reducing elevated triglycerides (TG), and elevating high density cholesterol (HDL), the “good” cholesterol”.
The clinical trial is a multi-center, randomized study evaluating the safety and efficacy of CRx-401, as an add-on therapy in type II diabetes, in comparison to bezafibrate alone. Approximately 80 subjects with type II diabetes who are poorly controlled on metformin are planned to be enrolled.
Patients will be randomized in a 1:1 ratio to CRx-401 (400mg bezafibrate sustained release and 250mg diflunisal) or 400mg of bezafibrate sustained release plus placebo. Patients will remain on their pre-existing stable dose of statins and low dose aspirin. Endpoints include fasting plasma glucose and insulin resistance.