Jun 23 2007, 8:00 AM EST
MARKETWIRE
Data to be presented at the American Diabetes Association's (ADA) 67th Annual Scientific Sessions in Chicago demonstrate that colesevelam HCl can lower both A1C and LDL cholesterol levels in patients with type 2 diabetes mellitus who were uncontrolled on a metformin-based regimen. The new colesevelam HCl clinical data findings from the pivotal studies are consistent with the pilot study findings. The data was included in Daiichi Sankyo's supplemental New Drug Application filed with the U.S. Food and Drug Administration (FDA) in December 2006. If approved, colesevelam HCl will be the first LDL cholesterol-lowering medication also indicated for improving glycemic control in patients with type 2 diabetes mellitus (DM).
The 26-week study of colesevelam HCl included patients with type 2 DM who had previously failed to reach glycemic control (ADA target of A1C < 7%) with metformin, a common oral medication for type 2 diabetes mellitus. Patients in the study were randomly assigned to two groups. The addition of colesevelam HCl tablets was compared to the addition of placebo in patients on a metformin-based regimen.
Two separate presentations of the study will be made at the ADA poster session on Sunday, June 24th. Dr. Harold Bays, MD, study investigator, and Medical Director of the Louisville Metabolic and Atherosclerosis Research Center in Kentucky, will describe colesevelam HCl's effect on A1C and glycemic control in a poster presentation titled "Effect of Colesevelam HCl on Glycemic Control in Type 2 Diabetic Subjects Receiving Metformin Monotherapy." The study demonstrated that the colesevelam HCl treatment group with metformin monotherapy cohort achieved significantly greater reductions in A1C levels compared to the placebo group (mean=0.47%, p < 0.0024). Further, the colesevelam HCl total treatment group (metformin monotherapy and combination therapy) achieved significantly greater reductions in A1C levels compared to placebo (mean=0.54%, p < 0.001). Fructosamine, another indicator of glycemic control, was also significantly reduced in the patients receiving colesevelam HCl (mean=17.8 micro mol/L, p < 0.05).
"Diabetes mellitus and hypercholesterolemia often coexist in patients," said Dr. Bays. "This study provides evidence that colesevelam HCl is not only safe and effective in improving cholesterol levels in patients with type 2 diabetes mellitus, but may also lower glucose levels as well."
The second presentation demonstrates colesevelam HCl's effect on LDL cholesterol and other lipid parameters. The poster presentation titled "Colesevelam HCl Improves the Lipid Profile in Type 2 Diabetic Subjects with Inadequate Glycemic Control on Metformin" notes that the colesevelam HCl treatment group achieved significantly lower LDL cholesterol levels compared to the placebo group (mean=15.9%, p < 0.001). The colesevelam HCl group also achieved significant reductions in apolipoprotein B levels and C-reactive protein, two known cardiovascular risk factors. Significant weight gain, a common side effect of some oral anti-diabetic agents, was not observed in the colesevelam HCl group. In this study, colesevelam HCl had no significant effect on triglycerides compared to placebo (median percent change=11.8% vs. 6.6%, p=0.221).
"Given the prevalence of diabetes and high LDL cholesterol, a medication that can help lower both A1C and LDL cholesterol can be beneficial for many patients," said Ronald B. Goldberg, MD, a lead investigator in the study and Professor of Medicine at the Division of Diabetes and Metabolism and Associate Director of the Diabetes Research Institute at the University of Miami, Miller School of Medicine in Florida. "A new therapeutic option that would addre
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