SAN DIEGO, Aug. 21 /PRNewswire-FirstCall/ -- Akesis Pharmaceuticals, Inc. today commented on a study published in the August issue of Diabetes Care which demonstrates the positive clinical effects of the trace element chromium when combined with a commonly-prescribed oral antidiabetic drug. The study, a randomized, double-blind, placebo-controlled trial conducted by researchers at Pennington Biomedical Research Center in Baton Rouge, LA, concludes that the addition of chromium to a regimen consisting of a sulfonylurea drug in subjects with type 2 diabetes significantly improves insulin sensitivity, improves glucose control, and attenuates body weight gain.(1)
Akesis is developing proprietary products designed to lower and control blood glucose levels in patients with type 2 diabetes and holds numerous issued patents and patent applications relating to the use of chromium, vanadium and other components with sulfonylureas and other classes of diabetic agents. In an open-label study, Akesis demonstrated significant reductions in glycated hemoglobin (HbA1c) levels in subjects with type 2 diabetes when administering one of its products in combination with sulfonylureas. The company is designing a double-blind placebo controlled clinical trial with a goal of confirming and extending the results of the initial study.
“We are encouraged by the growing number of placebo-controlled trials that support the significant potential benefits of combination therapy in the management of type 2 diabetes,” said Akesis president and CEO Edward B. Wilson. “Akesis looks forward to taking steps to confirm the clinical utility of its proprietary products in future company-sponsored studies.”
In the Pennington study, 37 subjects with type 2 diabetes were evaluated. After baseline measurements, subjects were placed on a sufonylurea (glipizide gastrointestinal therapeutic system 5 mg/day) with placebo for three months. Subjects were then randomized in a double-blind fashion to receive either sulfonylurea plus placebo or sulfonylurea plus 1,000 micrograms of chromium as chromium picolinate for six months. Body composition, insulin sensitivity, and glycemic control were determined at baseline, at the end of the three-month single-blind placebo phase, and at the end of the study.
About Akesis:
Akesis is a pharmaceutical company with a portfolio of innovative prospective treatments for diabetes and other related metabolic disorders. The company possesses issued U.S. patents for both prescription and over-the-counter treatments, which uniquely combine anti-diabetic trace minerals with certain classes of diabetes oral agents. Akesis’ products have demonstrated utility in lowering and controlling blood glucose levels in patients with type 2 diabetes. Blood sugar control via oral drugs represents a multi billion-dollar industry in the United States.
Note regarding forward-looking statements:
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Akesis Pharmaceuticals disclaims any intent or obligation to update these forward- looking statements, and claims the protection of the Safe Harbor for forward- looking statements contained in the Act. Examples of such statements include, but are not limited to, any plans to initiate clinical trials or to otherwise seek to confirm the utility of the company’s products. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the inability to raise additional capital, an amount of which is required to support completion of new clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the company’s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the company’s drug candidates that could slow or prevent clinical development, and product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials). For additional information about risks and uncertainties Akesis faces, see documents Akesis files with the Securities and Exchange Commission, including the report on Form 10-K for the fiscal year ended December 31, 2005, and all our quarterly and other periodic SEC filings. Akesis has not yet submitted any formulations to the Food and Drug Administration for review. The FDA has not made any determinations with regard to Akesis’ proposed formulations. Akesis does not, at this time, manufacture, or offer products for sale.
(1) Martin J, Wang Z, Zhang X, Wachtel, D, Volautova J, Matthews D, Cefalu W. Chromium Picolinate Supplementation Attenuates Body Weight Gain and Increases Insulin Sensitivity in Subjects With Type 2 Diabetes. Diabetes Care. Volume 29;8: 2006
Akesis Pharmaceuticals, Inc.
CONTACT: Bob Giargiari of GPR GLOBAL for Akesis Pharmaceuticals,+1-619-884-4410
Web site: http://www.akesis.com/
