Solvay Pharmaceuticals, Inc. Initiates AndroGel Study in Men with Diabetes and Low Testosterone
-- Patient Recruitment Underway --
Marietta, GA. (March 31, 2005) – Solvay Pharmaceuticals, Inc., announced today that it has initiated a proof of concept trial to evaluate the efficacy and safety of AndroGel® (testosterone gel) 1% CIII, as an adjunct to oral hypoglycemic therapy, in controlling blood sugar levels in men with type 2 diabetes and hypogonadism (also known as low testosterone or low T). DEMAND (DiabEtes in Men on ANDrogens) is the first trial to evaluate the role of testosterone gel in helping manage blood sugar levels in men with diabetes and low T.
It is estimated that low T affects up to 13 million men age 45 and older. Research suggests men with diabetes are at an increased risk of having low T. In fact, a recent study found that men with diabetes are twice as likely to have low T compared to other men.1
“This trial will help further the medical community’s understanding of the effects of testosterone therapy, specifically our product AndroGel®, in men with diabetes and low testosterone,” said Harold H. Shlevin, PhD, President and CEO of Solvay Pharmaceuticals, Inc. “We hope to provide these men with an effective and safe treatment option to help manage blood glucose levels, in addition to restoring testosterone levels and alleviating low testosterone symptoms.”
The double-blind, parallel, randomized, placebo-controlled study will enroll 180 patients at approximately 55 sites in the U.S. A study extension also is planned. Results will be collected and analyzed to develop a potential Phase III clinical trial.
Men who are interested in learning more about the clinical study are encouraged to phone 800-241-1643 (option #8) to receive additional information. To be considered for the study, men must be between the ages of 30 and 80, have a diagnosis of type 2 diabetes and have moderate control of their diabetes with oral hypoglycemic agents. Men also will be screened for low T with a simple blood test for final study inclusion.
About AndroGel®
AndroGel® is a once-daily, clear, odorless topical testosterone gel approved by the U.S. Food and Drug Administration in 2000 for replacement therapy in men for conditions associated with absent or low testosterone. AndroGel® is the first testosterone gel to be approved by the FDA. It is also the number one prescribed form of testosterone therapy in the United States.
AndroGel® is the first and only FDA-approved testosterone gel available in a non-aerosol, metered-dose pump, which is designed to deliver 1.25 grams of testosterone gel per pump depression. AndroGel® also is available in 2.5 and 5 gram packets. This gives patients two ways for using AndroGel® and offers physicians added flexibility to dose it from the starting dose of 5g per day to 7.5g or from 7.5g to 10g per day as needed.
Symptoms of low T may include diminished interest in sex, reduced muscle mass, decreased bone density, depressed mood and fatigue. Men with chronic conditions, such as diabetes, obesity and hypertension, are more likely to have low T compared to other men.
Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel® is not indicated for use in women, has not been evaluated in women, and must not be used in women. Geriatric patients treated with androgens may be at an increased risk for the development of enlarged prostate and prostate cancer. Please refer to the AndroGel® prescribing information for complete safety information.
About Solvay Pharmaceutical, Inc.
Solvay Pharmaceuticals, Inc. (www.solvaypharmaceuticals-us.com) of Marietta, Georgia (USA) is a research-driven pharmaceutical company that seeks to fulfill unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, women's health and a select group of specialized markets including men's health. It is a part of the global Solvay Pharmaceuticals organization whose core activities consist of discovering, developing and manufacturing medicines for human use. Solvay Pharmaceuticals, Inc. is a subsidiary corporation of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium.
1. Mulligan T. “The Hypogonadism in Males (HIM) Study: An epidemiological program to estimate the population prevalence of hypogonadism in men over 45.” American Academy of Family Physicians Annual Meeting, Orlando, FL. 2004. Dr. Mulligan is the Chief of Geriatrics at the McGuire Veterans Affairs Medical Center in Richmond, Virginia. This study was supported by Solvay Pharmaceuticals, Inc.
