Auxilium: In trial, Testim increases testosterone levels but misses primary endpoint

By E. Janene Geiss

Philadelphia, June 15 - Auxilium Pharmaceuticals, Inc. reported Thursday top-line results from its phase 4 randomized trial of Testim 1%, its topical testosterone gel, treatment in patients with type 2 diabetes that showed the drug raised testosterone levels but missed the trial's primary endpoint.

This double-blind, placebo-controlled study of 204 patients showed that patients treated with Testim experienced a statistically significant improvement in serum testosterone levels compared to those receiving a placebo, according to a company news release.

Patients in the Testim treatment group also experienced a statistically significant increase in lean body mass and a decrease in fat mass compared to the control group, confirming results from previous studies, officials said.

"These findings confirm past clinical studies demonstrating that restoring testosterone levels with Testim can help men lose fat mass and gain muscle mass, both of which are vital components in managing the effects of type 2 diabetes," Gerri Henwood, Auxilium's chief executive officer, said in the release.

The analysis of hemoglobin A1C levels, the primary endpoint of the study, did not show a statistically significant difference between the treatment groups. Hemoglobin A1C is an average measure of blood sugar over a two-to-three month period, and can determine whether a patient's blood sugar is under control over time, officials said.

But, the company said that the majority of patients started the study at the low end of the hemoglobin A1C entry range, which may have reduced the opportunity to demonstrate a statistically significant difference between the treatment groups.

Auxilium officials said they believe various factors related to patients' health prior to entering the study may have influenced the findings related to Testim's impact on hemoglobin A1C levels.

"While we observed significant changes in body composition, the treatment period may also have been too short to demonstrate the full impact of these effects on hemoglobin A1C. We believe further study of the impact of these beneficial effects is warranted," Jyrki Mattila, Auxilium's executive vice president of research and development, business development and technical operations, said in the release.

Study results showed that Testim appears to be safe when taken alongside oral hypoglycemic medications, and it did not interfere with their clinical effect.

The overall tolerability profile of Testim in patients with type 2 diabetes was consistent with the prescribing information for Testim.

Testim is a marketed, proprietary, topical 1% testosterone gel that treats hypogonadism (low testosterone) by raising testosterone blood levels back to normal.

Auxilium is a Malvern, Pa., specialty pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.