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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141492

Enrollment

Unknown

Registered

2005-09-01

Start date

2004-10-31

Completion date

2007-06-30

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Type 2 Diabetes

Keywords

Type 2 diabetes, hypogonadism, testosterone, glycosylated hemoglobin A1C

Brief summary

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.

Interventions

DRUGAndrogel (testosterone gel)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

30 Years to 80 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026