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

Solvay

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes; Hypogonadism

Treatments: Drug: Androgel (testosterone gel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141492

S176.2.101

Details and patient eligibility

About

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.

Sex: Male

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind