SOURCE: Daiichi Sankyo, Inc.

June 10, 2006 10:00 ET

First Clinical Trial to Demonstrate Colesevelam HCl Plus Stable Oral Antidiabetic Medication Improves Glycemic Control in Patients With Type 2 Diabetes

PARSIPPANY, NJ -- (MARKET WIRE) -- June 10, 2006 -- The first data to demonstrate the effect of WelChol® (colesevelam hydrochloride) on glucose lowering was presented today at The American Diabetes Association's (ADA) 66th Annual Scientific Sessions in Washington, DC. WelChol treatment resulted in a mean 0.5% reduction in A1C versus placebo (p=0.007). Moreover, in patients with A1C greater than or equal to 8.0%, WelChol lowered A1C by 1.0% compared to placebo (p=0.002).

The Glucose Lowering Effect Of WelChol Study (GLOWS) examined the ability of a bile acid sequestrant, colesevelam HCl, to improve glycemic control in addition to a patient's current oral antidiabetic therapy. Presented in three separate scientific posters at the ADA Scientific Sessions, the study also demonstrated fasting plasma glucose (FPG) lowering, with significant lowering seen at week 4 of -23.3 mg/dL (p=0.016) and week 8 of -18.3 mg/dL (p=0.011); decreases in fructosamine, another indicator of average blood sugar levels; lowering of postprandial glucose levels; and improvement in lipid indicators, including LDL-C, total cholesterol, non-HDL-C and apolipoprotein B.

The study was unique in that it examined WelChol when added to existing oral antidiabetic therapies, a study design element incorporated to reflect a more realistic physician treatment algorithm. Addition of WelChol did not cause weight gain, a typical side effect of glucose-lowering therapies, and did not cause increased incidence of hypoglycemia. As expected, WelChol maintained its lipid lowering abilities, with study results demonstrating significant mean reductions in LDL-C, total cholesterol, apo B, LDL particle concentration, and non-HDL-C.

"The benefit from treating these two cardiovascular risk factors simultaneously with one agent is an important advance for patients and physicians," said Sherwyn Schwartz, MD, study investigator and CEO/CMO of Diabetes and Glandular Research Associates in San Antonio, TX. "Every physician is looking to get every percentage decrease in A1C and LDL-C that they can. These results merit further study of WelChol for glycemic control in addition to LDL-C lowering in patients with type 2 diabetes."

About the Study

The study was designed as a 12-week, prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sixty-five patients were randomized, with 59 patients completing the study. The sample consisted of subjects aged 30 to 70 years of age with type 2 diabetes (per ADA criteria) and A1C levels between 7-10% (inclusive). Subjects were maintained on their stable dose(s) of sulfonylurea, metformin, or a combination of the two. Following a 4-week placebo run-in period, subjects were randomized to receive either colesevelam (3.75 g/day in 6 tablets/day) or matching placebo (6 tablets/day) for 12 weeks. The primary objective of the study was to evaluate the effect of colesevelam on glycemic control in subjects with type 2 diabetes, measured by change in A1C from baseline to week 12. Primary and secondary endpoints were presented in three separate posters at the ADA Scientific Sessions:

Poster #498 - "Lipid-Lowering Effects of Colesevelam Hydrochloride (HCl) in Patients with Type 2 Diabetes": Examines WelChol's effect on lipid parameters, including LDL-C, total-C, non-HDL-C, apolipoprotein B, LDL particle concentration, and triglycerides in patients with type 2 diabetes.

Poster #563 - "Colesevelam HCl Improves Glycemic Control in Patients with Type 2 Diabetes (T2DM): A Pilot Study": Examines WelChol's effect on fasting plasma glucose levels and A1C levels.

Poster #589 - "Colesevelam HCl Reduces Postprandial Glucose In Patients With Type 2 Diabetes Mellitus (T2DM)": Examines the effect of WelChol on mean postprandial glucose levels following a meal challenge.

About WelChol

WelChol, a non-absorbed specifically engineered bile acid sequestrant (SE-BAS) indicated for LDL-C lowering approved by the U.S. Food and Drug Administration (FDA) for marketing in May 2000, is the top-selling branded drug in the bile acid sequestrant (BAS) class. Because WelChol is engineered for affinity, specificity and high capacity bile acid binding, potential for drug-drug interaction may be reduced.

WelChol is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Systemic medications, which include the statin and fibrate classes, are those that are absorbed from the intestine into the bloodstream and travel throughout the body.

WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa) when the response to diet and exercise has been inadequate. Liver-function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.

In clinical trials with patients with primary hypercholesterolemia, WelChol, in addition to a low-fat diet and exercise, reduced LDL cholesterol by an average of 15 to 18 percent.

When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.75 g provided up to an additional mean 16 percent (32 mg/dL) reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin. It has been studied with four commonly prescribed statins -- Lipitor® (atorvastatin calcium), Zocor® (simvastatin), Pravachol® (pravastatin sodium) and Mevacor® (lovastatin).

WelChol is not for everyone, especially those with bowel blockage. Caution should be exercised when treating patients who have trouble swallowing or severe stomach or intestinal problems. Side effects may include constipation, indigestion and gas.

Like most prescription drugs, WelChol has not been studied in combination with all medications or supplements. Patients should always tell their doctor about all medications and supplements they are taking before starting any new therapy, including WelChol. WelChol has not been shown to prevent heart disease or heart attacks.

For more information on WelChol, call 877-4-DS-PROD (877-437-7763), or go to the WelChol web site at www.WelChol.com.

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. was established on April 3, 2006 as the U.S. subsidiary of Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. The company was formed by the merger of U.S. entities Sankyo Pharma Inc., Daiichi Pharmaceutical Corporation and Daiichi Medical Research. Headquartered in Parsippany, New Jersey, the company's strategic focus is on cardiovascular diseases. Research and development of new therapies is also focused in the areas of glucose metabolic disorders, infectious diseases, cancer, immunology and bone and joint diseases. Daiichi Sankyo's portfolio includes BENICAR® (olmesartan medoxomil), the fastest growing angiotensin receptor blocker on the market (1). For more information, please visit www.daiichisankyo-us.com.

Trademarks not owned by Daiichi Sankyo, Inc. are the property of their respective owners.

(1) Data are representing May 2002 - February 2006 from IMS Health. National Prescription Audit, February 2006.

Contact Information

  • For more information, please contact:

    Julia Lamm
    Hill & Knowlton
    212-885-0413
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