Data from Pooled Analyses Demonstrates Welchol, Combined with Metformin- or Sulfonylurea-Based Therapy, Significantly Lowers Blood Glucose in Adults with Type ...( First and Only Therapy Approved to Tr...),Health

First and Only Therapy Approved to Treat Both Type 2 Diabetes and High LDL-

Cholesterol

Welchol Recently Added to ACE/AACE Road Maps

PARSIPPANY, N.J., May 16 /PRNewswire/ -- Daiichi Sankyo, Inc. (DSI) announced today that data from two pooled analyses further demonstrate that Welchol(TM) (colesevelam HCl), in combination with metformin- or sulfonylurea- based therapy, significantly lowers blood glucose (as measured by A1C) in patients with type 2 diabetes mellitus who had failed to achieve glycemic control (ADA target of A1C <7%). These findings, presented at the American Association of Clinical Endocrinologists' (AACE) 17th Annual Meeting and Clinical Congress, are the latest in a series of diabetes-related milestones for Welchol. In April, DSI announced that Welchol was added to the American College of Endocrinology (ACE)/AACE "Road Maps to Achieve Glycemic Control in Type 2 Diabetes Mellitus."

The efficacy of Welchol compared to placebo was evaluated in patients receiving metformin-based or sulfonylurea-based therapy (either monotherapy or in combination with other antidiabetes therapy) in two separate pooled analyses of patients from three Welchol pivotal studies.* The addition of Welchol in patients on established metformin-based therapy demonstrated a significant mean A1C reduction of 0.50%, placebo-corrected change from baseline (mean baseline A1C was 8.2% for both Welchol and placebo). In a second pooled analysis, the addition of Welchol in patients on established sulfonylurea-based therapy demonstrated a mean reduction in A1C of 0.53%, placebo-corrected change from baseline (mean baseline A1C was 8.2% and 8.3% for Welchol and placebo, respectively).

"These analyses further demonstrate the potential benefit of adding Welchol to current common diabetes treatment regimens," said Vivian E. Fonseca, Professor of Medicine and Pharmacology and Chief, Section of Endocrinology, Tulane Univer
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