Colesevelam HCI Added to Background Metformin Therapy in Patients With Type 2 Diabetes Mellitus: A Pooled Analysis From Three Clinical Studies
Endocrine Practice, 08/24/2011
Clinical Article
Bays HE – When added to metformin–including therapy, colesevelam HCI reduced hemoglobin A1c (HbA1c) and significantly reduced low–density lipoprotein cholesterol (LDL–C), total cholesterol (TC), non–high–density lipoprotein cholesterol (non–HDL–C), and apoB in patients with inadequately controlled type 2 diabetes mellitus (T2DM).
Methods- This post–hoc analysis included T2DM patients from three randomized, double–blind, placebo–controlled pivotal studies who received metformin as part of their background antidiabetes therapy.
- In the pivotal studies, T2DM patients were randomized to colesevelam HCI 3.75 g/day or placebo added to existing metformin (26 weeks), sulfonylurea (26 weeks), or insulin (16 weeks) monotherapy or combination therapy, wherein the combination therapies may have included metformin.
- In this pooled analysis of 696 T2DM patients receiving metformin monotherapy or metformin combined with other antidiabetes therapies, 355 were randomized to colesevelam HCI and 341 to placebo.
- Compared to placebo, colesevelam HCI significantly reduced hemoglobin A1c (HbA1c) and fasting plasma glucose (mean treatment difference: –0.50% and – 15.7 mg/dL, respectively; P<.001 for both), as well as significantly reduced levels of low–density lipoprotein cholesterol (LDL–C; mean treatment difference: –16.5%), total cholesterol (TC; – 5.8%), non–high–density lipoprotein cholesterol (non–HDL–C; –8.2%), and apolipoprotein (apo) B (–7.6%; P<.0001 for all).
- Median triglyceride levels were increased with colesevelam HCI (treatment difference: +12.8%; P<.0001).
- When compared to placebo, colesevelam HCI significantly increased apoA–I (mean treatment difference: +3.3%; P<.0001), while the mean increase in HDL–C with colesevelam HCI was not significant.
- Colesevelam HCI therapy was generally well tolerated.