Abstract 1581: Colesevelam HCl Improves Glycemic Control in Type 2 Diabetes Basic Science Mellitus (T2DM) Subjects Managed With Insulin Therapy
Anecdotal reports and pilot study results suggest that colesevelam, a specifically engineered bile acid sequestrant improves glycemic control in patients with T2DM. A 16 week multicenter, randomized, double-blind, placebo-controlled trial evaluated the antihyperglycemic effects of colesevelam in subjects with T2DM uncontrolled (A1C 7.5%–9.5%, inclusive) on insulin, alone or in combination with oral antihyperglycemics (OAH). Following a 2-week single-blind placebo run-in, subjects were randomized to either colesevelam 3.75 g/d (n=147) or placebo (n=140). Daily mean insulin use was similar in both groups at baseline. Subjects were maintained on existing OAH, and insulin doses were to remain within ±10% of baseline dose. Primary endpoint was placebo-corrected change from baseline in A1C at week 16 last observation carried forward (LOCF). The intent-to-treat population included 280 subjects; mean baseline A1C was 8.3% in both colesevelam (n=144) and placebo groups (n=136). At week 16 LOCF, mean change from baseline in A1C was −0.41% with colesevelam and +0.09% with placebo (treatment effect -0.50%; p<0.0001). Colesevelam also resulted in significant mean decreases in LDL-C (12.8%) and apo B (5.3%) and increases in apo A-I (2.3%) and median TG (21.5%). No change in mean insulin dose occurred in either group (as per protocol). The incidence of drug related adverse events were 16.3% and 9.3% in the colesevelam and placebo groups, respectively. There was no difference among groups in hypoglycemia events (6.1% with colesevelam and 7.9% with placebo), change in weight or lab-safety parameters. These results support the efficacy and safety of colesevelam to enhance glycemic control and improve lipid profiles in subjects with T2DM, on an insulin-containing regimen.