Daiichi says Welchol improves glycemic control

By Elaine Rigoli

Tampa, Fla., June 12 - Daiichi Sankyo released data showing that WelChol (colesevelam hydrochloride) showed glucose-lowering effects, including a mean 0.5% reduction in A1C versus a placebo.

Moreover, in patients with A1C greater than or equal to 8.0%, WelChol lowered A1C by 1.0% compared to a placebo.

The study examined the ability of a bile acid sequestrant, colesevelam HCl, to improve glycemic control in addition to a patient's current oral anti-diabetic therapy.

The study also demonstrated fasting plasma glucose lowering, with significant lowering seen at week four of -23.3 mg/dL and week eight of -18.3 mg/dL; decreases in fructosamine, another indicator of average blood sugar levels; lowering of postprandial glucose levels; and improvement in lipid indicators, including LDL-C, total cholesterol, non-HDL-C and apolipoprotein B.

The company said this study was unique in that it examined WelChol when added to existing oral anti-diabetic therapies, a study design element incorporated to reflect a more realistic physician treatment algorithm.

Addition of WelChol did not cause weight gain, a typical side effect of glucose-lowering therapies, and did not cause increased incidence of hypoglycemia.

Daiichi Sankyo, the U.S. subsidiary of Japanese pharmaceutical company Daiichi Sankyo Co., Ltd., has headquarters in Parsippany, N.J.

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