Rationale and design of a prospective clinical trial program to evaluate the glucose-lowering effects of colesevelam HCl in patients with type 2 diabetes mellitus

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Abstract
Background: Dyslipidemia and type 2 diabetes mellitus (T2DM) increase atherosclerotic coronary heart disease (CHD) risk. In patients with T2DM, improving lipid parameters reduces CHD risk, while optimizing glucose levels reduces microvascular complications and, possibly, macrovascular disease such as CHD. Unfortunately, many patients with T2DM do not achieve either lipid or glucose treatment targets.Objective: Colesevelam HCl is a specifically engineered bile-acid sequestrant (BAS) indicated to reduce elevated low-density lipoprotein cholesterol concentrations. Earlier studies have demonstrated that BAS not only reduce cholesterol levels, but also lower glucose levels in patients with T2DM. These findings have prompted a robust, prospective phase 3 clinical trial program to further evaluate the safety and tolerability of colesevelam HCl when added to T2DM patients previously treated with metformin, insulin or a sulfonylurea. A limitation of these clinical trials is that none of them assessed coles...

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