Colesevelam hydrochloride lowered HbA1c in patients with type 2 diabetes

Treatment with colesevelam hydrochloride demonstrated improvements in glycemic and lipid parameters in patients with type 2 diabetes who were inadequately controlled with metformin-based therapy, according to the findings from a new trial.

The researchers from Louisville, Ky., Miami, Fla. and New Jersey conducted a randomized, controlled trial during 26 weeks. The trial was conducted in 54 sites in the United States and two sites in Mexico.

Patients were assigned to 3.75 g/day of colesevelam hydrochloride (Welchol, Daiichi Sankyo, n=159) or placebo (n=157).

Colesevelam decreased the mean HbA1c level by –0.54% compared with placebo (P<.001), according to the researchers. In the metformin monotherapy group, HbA1c levels decreased by –0.47% (P=.002) and in the combination therapy group, by –0.62% (P<.001).

In the colesevelam hydrochloride group, levels were lowered for fasting plasma glucose (–13.9 mg/dL; P=.01), fructosamine (–23.2 mcmol/L; P<.001) and total cholesterol (–7.2%; P<.001).

Researchers also observed decreases in LDL cholesterol (–15.9%; P<.001), apolipoprotein B (–7.9%; P<.001), non-HDL cholesterol (–10.3%; P<.001) and C-reactive protein (–14.4%; P=.02). – by Christen Haigh

Arch Intern Med. 2008;168:1975-1983.

Colesevelam hydrochloride has been used for some time for managing hyperlipidemia. It is now approved for use in type 2 diabetes for blood glucose control, as it has been shown to improve HbA1c by 0.5%. Clearly, there may be an advantage to its use in that it 'kills two birds with one stone.' How it fits into the algorithm of type 2 diabetes mellitus management, remains to be studied.

– Derek LeRoith, MD, PhD

Endocrine Today Editorial Board member