Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes; Hypogonadism

Intervention: Androgel (testosterone gel) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

Official title: A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Androgel, as an Adjunct to Hypoglycemic Therapy, in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

1. Able to read and write

2. Males

3. Between 30-80 years old

4. Have type 2 diabetes

5. Diagnoses of hypogonadism or low testosterone

Exclusion Criteria:

1. On insulin monotherapy

2. Use of testosterone therapy within the last 6 months

3. Male breast cancer

4. History of prostate cancer

5. History of clinically significant sleep apnea

Site 54, Mobile, Alabama, United States

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Site 16, Phoenix, Arizona, United States

Site 1, Torrance, California, United States

Site 8, Los Gatos, California, United States

Site 12, Mission Viejo, California, United States

Site 23, Concord, California, United States

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Site 25, Glastonbury, Connecticut, United States

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Site 40, Tupelo, Mississippi, United States

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Starting date: October 2004
Last updated: September 6, 2007