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Randomized Controlled Trial
. 2008 Aug;31(8):1479-84.
doi: 10.2337/dc08-0283. Epub 2008 May 5.

Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy

Affiliations
Randomized Controlled Trial

Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy

Vivian A Fonseca et al. Diabetes Care. 2008 Aug.

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 VSports手机版. .

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 antidiabetes agents. In total, 461 patients were randomized (230 given colesevelam 3. 75 g/day and 231 given placebo) V体育安卓版. 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 least squares (LS) mean change in A1C from baseline to week 26 was -0 V体育ios版. 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 relative to placebo group at week 26. .

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

Trial registration: ClinicalTrials. gov NCT00147758. V体育平台登录.

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Figures

Figure 1
Figure 1
Subject disposition.
Figure 2
Figure 2
A: Mean change in A1C (%) from baseline to weeks 6, 12, 18, and 26 (LOCF) in the ITT population. *P < 0.001 vs. placebo. B: Mean percent change in lipid and apo parameters from baseline to week 26 (LOCF) in the ITT population. *P < 0.001 vs. placebo. †Triglycerides (TGs) reported as median rather than mean.

References

    1. Klein R: Hyperglycemia and microvascular and macrovascular disease in diabetes. Diabetes Care 18:258–268, 1995 - PubMed
    1. Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M: Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 28:103–117, 1995 - PubMed
    1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986, 1993 - V体育平台登录 - PubMed
    1. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837–853, 1998 - PubMed (VSports手机版)
    1. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 352:854–865, 1998 - PubMed

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