WASHINGTON — An old drug evidently has a new trick.
Colesevelam (WelChol), approved in the United States since 2000 for lowering lipid levels, also appears to reduce postprandial glucose in patients with type 2 diabetes, Dr. Franklin Zieve and his associates reported in a poster at the annual scientific sessions of the American Diabetes Association.
The incidental observation prompted Daiichi Sankyo Inc. to sponsor a prospective study of the glucose-lowering effects of its bile acid sequestrant drug, Dr. Zieve of the Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Va., said in an interview at the meeting.
A total of 65 patients with type 2 diabetes with hemoglobin A1c levels of 7.0% or above were randomized to receive 3.75 g/day of colesevelam (6 tablets/day) or placebo for 12 weeks, following a 4-week placebo run-in period. Patients continued taking their existing antidiabetic medications, which included sulfonylurea and/or metformin. Thirty-two colesevelam and 27 placebo subjects completed the trial.
At 12 weeks, mean postprandial glucose levels were reduced by a significant 18 mg/dL (from 269 to 251) in the colesevelam group, compared with an insignificant gain of 3 mg/dL (285 to 288) in the placebo group. Fasting plasma glucose levels dropped by 5 mg/dL (170 to 165) with colesevelam, vs. a gain of 2 mg/dL with placebo. Hemoglobin A1c levels dropped by about 0.3 percentage points from baseline with colesevelam, a 0.5 percentage-point difference from placebo at 12 weeks.
The colesevelam and placebo groups had similar incidences of treatment-emergent adverse events during the study. There were no clinically significant changes in body mass index or in hypoglycemic events when the study drugs were added to existing sulfonylurea or metformin therapy.