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Colesevelam HCl Improves Glycemic Control and Reduces LDL-Cholesterol in Patients with Type 2 Diabetes Inadequately Controlled on Sulfonylurea-Based Therapy

¹Tulane University Health Sciences Center, 1430 Tulane Avenue – SL 53, New Orleans, LA 70112
²Dallas Diabetes and Endocrine Center, Dallas, TX
³Daiichi Sankyo Pharma Development, Edison, NJ
⁴Daiichi Sankyo, Inc., Parsippany, NJ

vfonseca{at}tulane.edu

ABSTRACT

Objective: Hyperglycemia is a risk factor for microvascular complications and may increase the risk of cardiovascular disease in patients with type 2 diabetes. This study tested the LDL-cholesterol–lowering agent colesevelam HCl (colesevelam) as a potential novel treatment for improving glycemic control in patients with type 2 diabetes on sulfonylurea-based therapy.

Research Design and Methods: A 26-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study was carried out between August 2004 and August 2006 to evaluate the efficacy and safety of colesevelam for reducing A1C in adults with type 2 diabetes whose glycemic control was inadequate (A1C 7.5%–9.5%) with existing sulfonylurea monotherapy or sulfonylurea in combination with additional oral antidiabetic agents. In total, 461 patients were randomized (230 [colesevelam 3.75 g/day] and 231 [placebo]). The primary efficacy measurement was mean placebo-corrected change in A1C from baseline to Week 26 in the intent-to-treat population (last observation carried forward).

Results: The LS mean change in A1C from baseline to Week 26 was –0.32% in the colesevelam group and +0.23% in the placebo group, resulting in a treatment difference of –0.54% (P<0.001). The LS mean percent change in LDL-cholesterol from baseline to Week 26 was –16.1% in the colesevelam group and +0.6% in the placebo group, resulting in a treatment difference of –16.7% (P<0.001). Furthermore, significant reductions in fasting plasma glucose, fructosamine, total cholesterol, non–HDL-cholesterol, and apolipoprotein B were demonstrated in the colesevelam group relative to placebo at Week 26.

Conclusions: Colesevelam improved glycemic control and reduced LDL-cholesterol levels in patients with type 2 diabetes receiving sulfonylurea-based therapy.

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