Testosterone Therapy Doesn’t Help Men with Type 2 Diabetes

New research from Australia suggests that testosterone therapy does not improve sexual symptoms or general health in aging, obese men who have low testosterone and type 2 diabetes.

Funded by Bayer Pharma AG, the Berlin-based manufacturer of testosterone drug Nebido, the study recently appeared in The Journal of Clinical Endocrinology & Metabolism.

“The fact that testosterone treatment did not lead to a substantial symptomatic improvement is consistent with the possibility, supported by observational studies, that constitutional and sexual symptoms in this population may be a consequence of comorbidities, rather than due to the modest hypotestosteronemia,” the authors said.
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They conducted a randomized, double-blind, placebo-controlled trial to assess the effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes.

They examined 88 study participants—men ages 35 to 70 who had type 2 diabetes, a HbA1c < 8.5%, and a total testosterone level < 12.0 nmol/L, with mild-to-moderate aging male symptoms and erectile dysfunction.

They randomly assigned the patients to receive either 40 weeks of 1000mg of intramuscular testosterone undecanoate or a placebo. At 0, 18, and 40 weeks, they measured general health and sexual symptoms using self-administered questionnaires. They also measured total testosterone levels and other biochemical markers through fasting blood tests at these same intervals.

They found no substantial improvements in men using the treatment compared to the placebo. They concluded that the evidence from this trial does not support the use of testosterone therapy to improve general health or sexual symptoms in aging men with type 2 diabetes.

“The negative findings of this randomized, controlled trial do not rule out the possibility that testosterone treatment may lead to asymptomatic improvement in aging obese men with type 2 diabetes, but make it unlikely that a substantial, clinically meaningful response occurs in such men,” the authors said.

They suggest that testosterone therapy wasn’t helpful in this patient population because these men had other health conditions that contribute to low testosterone, which can’t simply be fixed by taking additional testosterone. However, their results suggest that treating the comorbidities in this patient population may be more beneficial than using hormone therapy.

“The fact that constitutional and sexual symptoms were associated with depression and with microvascular complications of diabetes, but not with circulating testosterone levels, is consistent with the possibility that prevention and care of comorbidities and of diabetes-related complications may yield more marked symptomatic benefits than testosterone therapy, although this hypothesis is yet to be tested in adequately designed clinical trials,” the authors said.

—Colleen Mullarkey

Reference

Gianatti EJ, Dupuis P, Hoermann R, Zajac JD, Grossmann M. Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial. J Clin Endocrinol Metab. 2014 Jun 30:jc20141872. [Epub ahead of print].