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Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men With Type 2 Diabetes and Metabolic Syndrome
Date:6/17/2008

that testosterone may play over the long-term in hypogonadal men with Type 2 diabetes."

In U.S. men aged 40-69 years, it is estimated that there are about 481,000 new cases of hypogonadism per year. Overall, approximately 2.4 million U.S. men suffer from the condition.(1) Hypogonadism results from a deficiency in testosterone secretion that may occur naturally with increasing age, or as a result of disorders of the hypothalamus, pituitary glands or testes. Men with the condition can experience reduced libido and sexual function, reductions in energy and body strength, changed physique, alterations in well-being, and reduced quality of life.(2)

"Awareness of the problems caused by low testosterone is becoming more widespread and its connection to health issues like diabetes continues to become increasingly apparent," said Professor Jones. "As the incidence of hypogonadism continues to grow along with the aging population, we need to be acutely aware and implement a more rigorous screening program, particularly in men with Type 2 diabetes."

About TIMES 2

The TIMES 2 study was a randomized, double-blind, placebo-controlled, multi-center, international study to assess the effect of daily transdermal testosterone replacement therapy in hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome.

The primary endpoint of the study was to determine the effect of 2% testosterone gel (Tostran) on insulin resistance in all patients. This was measured by sampling the patients' blood and measuring insulin and glucose levels to calculate HOMA-IR, an index of insulin resistance. Insulin resistance is a major biochemical defect in Type 2 diabetes and Metabolic Syndrome. It is associated not only with the development of high blood sugars but also with abnormalities in the lipid profile and other biochemical changes which increase the risk of cardiovascular disease.

Secondary endpoints included: change in lipid profile and abdominal obesit
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SOURCE ProStrakan
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