Source: Eur Urol  |  Posted 5 years ago

By Jill Stein

WASHINGTON, DC -- June 12, 2006 -- The addition of the bile acid sequestrant colesevelam HCl to existing antidiabetic therapy may improve glycaemic control in patients with type 2 diabetes, investigators reported here at the American Diabetes Association 66[^]th[] Scientific Sessions (ADA).

Sherwyn Schwartz, MD, director, Diabetes and Glandular Disease Clinic, San Antonio, Texas, United States, and associates evaluated the effect of colesevelam on glycaemic control in 65 patients with type 2 diabetes who were not adequately controlled with their current antidiabetic regimens.

Subjects had been treated for at least 3 months prior to enrolment with a stable dose of a sulfonylurea, metformin, or their combination. At randomisation, their haemoglobin A1c (HbA1c) level was 7.0% to 10.0%, inclusive.

Following 4 weeks of placebo run in, patients were randomised to colesevelam HCl 3.75 g/day or placebo 6 tablets per day. Subjects were instructed to continue their pre-existing antidiabetic treatment regimens.

The primary study endpoint was mean change in HbA1c level from baseline to week 12.

Results showed that fasting plasma glucose levels (least squares mean ? standard deviation) was significantly lower in the colesevelam HCl group compared with the placebo group at weeks 4 (-23 ? 9 mg/dL, []P[] = .016) and 8 (-18? 7 mg/dL, []P[] = .011). HbA1c levels also tended to be lower at week 12 (-14 ? 9 mg/dL, []P[] = .118).

Treatment resulted in a 0.5% decrease in HbA1c versus placebo in the total population, Dr. Schwartz said in his presentation on June 10[^]th[].

Colesevelam reduced HbA1c by 1.0% compared with placebo ([]P[] = .002) in patients with baseline HbA1c 8.0% or greater.

Overall, colesevelam was safe and well tolerated. Constipation was the most frequent treatment-emergent adverse event, and occurred in 6 patients in the active treatment group. Two serious adverse events (atrial flutter/chest pain and gastroenteritis) occurred during the randomised treatment period in the placebo group. Two patients in the colesevelam group and 1 in the placebo group withdrew from the study because of an adverse event.

The study was sponsored by Daichi Sankyo, Inc.

[Presentation title: Colesevelam HCl Improves Glycaemic Control in Patients With Type 2 Diabetes (T2DM): A Pilot Study. Abstract 563-P]