CHICAGO – The cholesterol-lowering drug colesevelam HCl improves glycemic control in patients with type 2 diabetes who are inadequately controlled with metformin monotherapy, Dr. Harold E. Bays reported in a poster presentation at the annual scientific sessions of the American Diabetes Association.
The bile acid sequestrant colesevelam HCl, sold under the name WelChol, has been approved in the United States for LDL cholesterol lowering since 2000. In January, WelChol's manufacturer, Daiichi Sankyo Inc., filed a supplemental new drug application with the Food and Drug Administration for a new glucose-lowering indication. Overall results of a pivotal randomized, placebo-controlled trial involving 316 adults with type 2 diabetes who were inadequately controlled with other oral agents, were presented earlier this year at a meeting of the American Association of Clinical Endocrinologists.
At that meeting, Dr. Bays, of Louisville (Ky.) Metabolic and Atherosclerosis Research Center Inc., presented the results of a subgroup analysis of the 155 patients who were on metformin monotherapy, in which 79 received 3.75 g/day of colesevelam and 76 took placebo. At week 26, the intent-to-treat analysis revealed a significant reduction in mean hemoglobin A1c (HbA1c) of 0.47% with colesevelam and a 17.8 micromol/L drop in fasting plasma glucose, both relative to placebo. Significantly more patients in the colesevelam group had reductions in HbA1c of more than 0.7% by week 26 (41% vs. 22%).
Mean changes in laboratory parameters, vital signs, and weight from baseline were similar in the two groups. Drug-related treatment-emergent adverse effects occurred in 18% of the colesevelam group and 12% of the placebo group, but most were mild or moderate. The only serious adverse event occurred in a placebo subject.
A second poster, presented by Dr. Ronald B. Goldberg of the University of Miami, showed that colesevelam significantly improved lipid profiles in the 316 study patients with type 2 diabetes, including reductions from baseline of 16% for LDL cholesterol, 10% for non-HDL cholesterol, 7% for total cholesterol, and 8% for Apo B.