June 11, 2005

New Data Show Low Testosterone More Likely in Men with Diabetes

Marietta, Ga. (June 11, 2005) "“ Men with diabetes age 45 and older may be more than twice as likely as non-diabetic men to have low testosterone levels, according to new data announced at the American Diabetes Association Annual Meeting and Scientific Session in San Diego. Results of this multi-center study, which screened more than 2,000 men, also found sexual dysfunction to be the most common symptom experienced by men with diabetes and low testosterone (known also as hypogonadism or low T). These data are a subset analysis of the Hypogonadism in Males (HIM) study.

It is estimated that low T affects up to 13 million American men age 45 and older, yet fewer than 10 percent are currently receiving treatment. Because symptoms of low T are subtle and often overlap with other common medical conditions, low T is frequently undiagnosed. The signs and symptoms of low T may include diminished interest in sex, erectile dysfunction (ED), increased fat mass, reduced muscle mass and strength, decreased bone mineral density, depressed mood and fatigue. Men with chronic conditions, such as diabetes, obesity, hypertension, hyperlipidemia and asthma/COPD, are more likely to have low T compared to other men.

"In our study, more than half of the men with diabetes also had low testosterone levels suggesting a higher prevalence of low T among diabetic men than previously reported," said Dr. Sherwyn L. Schwartz, co-investigator and director of the Diabetes & Glandular Disease Clinic in San Antonio. "Men with diabetes who have signs or symptoms of low testosterone should have their testosterone levels checked with a simple blood test. If you're diagnosed with low T, the good news is that the condition very often is treatable."

Several studies have reported that a higher proportion of men with diabetes may have significantly lower testosterone levels than men without diabetes. This is the first cross-sectional study of this size to assess the prevalence and odds ratio of diabetes and hypogonadism in men.

Physicians at 95 sites in 26 states screened 2,162 men (mean age = 60.5) for low T and diabetes. Hypogonadism was defined as total testosterone level less than 300 ng/dL or men currently receiving testosterone treatment for low T. Investigators found 38.7 percent (crude prevalence), or 836 of the 2,162 men, had low T and 23 percent, or 495 of the 2,162 men, had a history of diabetes. Of the 836 men with low T, 756 were not receiving testosterone treatment. In patients with a history of diabetes not receiving testosterone (n=474), 50 percent, or 237, had hypogonadism. Using these figures, investigators determined that men age 45 and older with diabetes have 2.09 times higher odds of having hypogonadism compared to non-diabetic men. Furthermore, 55.8 percent of men with diabetes and low T self-reported a decreased ability/frequency to perform sexually, making sexual dysfunction one of the most common low T symptoms among this group.

The research was supported by Solvay Pharmaceuticals, Inc., the marketers of AndroGel® 1% (testosterone gel) CIII, an FDA-approved topical testosterone replacement gel.

"Solvay Pharmaceuticals is committed to helping physicians better understand the possible link between diabetes and low testosterone in men," said Harold H. Shlevin, Ph.D., president and CEO of Solvay Pharmaceuticals. "To build on this research, we have initiated a trial to evaluate our product AndroGel® as an adjunct to oral hypoglycemic therapy in diabetic men with low testosterone."

In March 2005, Solvay Pharmaceuticals announced the initiation of a proof of concept trial, known as DEMAND (DiabEtes in Men on ANDrogens), to evaluate the efficacy and safety of AndroGel® in men with type 2 diabetes and hypogonadism. 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.

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