Daiichi Sankyo’s WelChol demonstrates glucose-lowering effect

The data, presented at the American Diabetes Association's annual scientific sessions, show that WelChol treatment resulted in a mean 0.5% reduction in A1C versus placebo. Moreover, in patients with A1C greater than or equal to 8%, WelChol lowered A1C by 1% compared to placebo.

The Glucose-Lowering Effect Of WelChol Study (GLOWS) examined the ability of a bile acid sequestrant, colesevelam HCl, to improve glycemic control in addition to a patient's current oral antidiabetic therapy.

Presented in three separate scientific posters, the study also demonstrated fasting plasma glucose (FPG) 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 study was unique in that it examined WelChol when added to existing oral antidiabetic therapies, a study design element incorporated to reflect a more realistic physician treatment algorithm.

As expected, WelChol maintained its lipid-lowering abilities, with study results demonstrating significant mean reductions in LDL-C, total cholesterol, apo B, LDL particle concentration, and non-HDL-C.

“The benefit from treating these two cardiovascular risk factors simultaneously with one agent is an important advance for patients and physicians,” said Dr Sherwyn Schwartz, study investigator and CEO of Diabetes and Glandular Research Associates in San Antonio, TX. “Every physician is looking to get every percentage decrease in A1C and LDL-C that they can. These results merit further study of WelChol for glycemic control in addition to LDL-C lowering in patients with type 2 diabetes.”