Testosterone replacement therapy of little help in preventing diabetes in hypogonadal men

Testosterone replacement therapy in men with hypogonadism does not appear to reduce the risk of developing diabetes, according to the results of the TRAVERSE* substudy.

The nested substudy included 5,055 men with hypogonadism and prediabetes or diabetes who participated in TRAVERSE. These men were randomly assigned to receive 1.62% testosterone gel or placebo gel until study completion.

Repeated-measures log-binomial regression was used to evaluate the primary endpoint of the risk of progression from prediabetes to diabetes. The risk of glycaemic remission (HbA1c level <6.5 percent or two fasting glucose measurements <126 mg/dL without diabetes medication) in men who had diabetes was also assessed as the secondary endpoint.

Of the participants, 1,175 had prediabetes (mean age 63.8 years, mean HbA1c level 5.8 percent) and 3,880 had diabetes (mean age 63.2 years).

In the prediabetes cohort, the testosterone and placebo groups did not significantly differ in terms of the risk of progression to diabetes at 6 months (0.7 percent vs 1.4 percent), at 12 months (7.8 percent vs 10.7 percent), at 24 months (10.1 percent vs 14.6 percent), at 36 months (12.8 percent vs 15.8 percent), and at 48 months (13.4 percent vs 15.7 percent; p=0.49).

In the diabetes cohort, the testosterone and placebo groups had similar proportions of participants who experienced glycaemic remission.

Likewise, there were no significant between-group differences in the changes in glucose and HbA1c levels in both the prediabetes and diabetes cohorts.

The present data do not support the use of testosterone replacement therapy alone to prevent or treat diabetes in men with hypogonadism.

*Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men