Background: Poor glycemic control is a risk factor for microvascular complications in patients with type 2 diabetes mellitus. Achieving glycemic control safely with insulin therapy can be challenging VSports手机版. .

Methods: A prospective, 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted at 50 sites in the United States and 1 site in Mexico between August 12, 2004, and December 28, 2005 V体育安卓版. Subjects had type 2 diabetes mellitus that was not adequately controlled (glycated hemoglobin level, 7. 5%-9. 5%, inclusive) receiving insulin therapy alone or in combination with oral antidiabetes agents. In total 287 subjects (52% men; mean age, 57 years; with a mean baseline glycated hemoglobin level of 8. 3%) were randomized: 147 to receive colesevelam hydrochloride, 3. 75 g/d, and 140 to receive placebo. .

Results: Using the least squares method, the mean (SE) change in glycated hemoglobin level from baseline to week 16 was -0. 41% (0. 07%) for the colesevelam-treated group and 0. 09% (0. 07%) for the placebo group (treatment difference, -0. 50% [0. 09%]; 95% confidence interval, -0. 68% to -0. 32%; P < V体育ios版. 001). Consistent reductions in fasting plasma glucose and fructosamine levels, glycemic-control response rate, and lipid control measures were observed with colesevelam. As expected, the colesevelam-treated group had a 12. 8% reduction in low-density lipoprotein cholesterol concentration relative to placebo (P < . 001). Of recipients of colesevelam and placebo, respectively, 30 and 26 discontinued the study prematurely; 7 and 9 withdrew because of protocol-specified hyperglycemia, and 10 and 4 withdrew because of adverse events. Both treatments were generally well tolerated. .

Conclusions: Colesevelam treatment seems to be safe and effective for improving glycemic control and lipid management in patients with type 2 diabetes mellitus receiving insulin-based therapy, and it may provide a novel treatment for improving dual cardiovascular risk factors VSports最新版本. .