Study will test testosterone gel in hypogonadal men with diabetes

Testosterone gel (AndroGel) 1% will be evaluated for its efficacy and safety as an adjunct to oral hypoglycemic therapy in men with type 2 diabetes and hypogonadism, according to its manufacturer, Solvay Pharmaceuticals, Inc.

The company has initiated a proof of concept trial, and patient recruitment is underway. The double-blind, parallel, randomized, placebo-controlled study will enroll 180 patients at about 55 U.S. sites. A study extension also is planned. Results will be collected and analyzed to develop a potential phase III clinical trial.

To be considered in the study, men must be between 30 and 80 years, 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 testosterone with a blood test for final study inclusion.