Testosterone Therapy for Low Testosterone and Diabetes

Overseen By Paula A Kinsel, MHA MBA

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must not be taking: Androgen therapy, Estrogen, Bisphosphonates, others

Disqualifiers: Prostate cancer, Testicular disease, Severe sleep apnea, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 months

92 Participants Needed

Trial Summary

What is the purpose of this trial?

Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they affect bone metabolism, such as estrogen, certain steroids, and bisphosphonates. The trial does not specify a washout period, but these medications are listed as exclusions.

What data supports the effectiveness of the drug testosterone gel 1.62% for low testosterone and diabetes?

Research shows that testosterone gel 1.62% is effective in treating low testosterone levels in men, as it helps restore testosterone to normal levels in most patients. This suggests it could be beneficial for men with low testosterone and diabetes, as improving testosterone levels may help manage symptoms related to both conditions. ^{1 2 3 4 5}

Is testosterone gel safe for humans?

Testosterone gel, including the 1.62% and 2% formulations, has been generally found to be safe and well-tolerated in studies with hypogonadal men. Common side effects are mild to moderate skin reactions, and no serious adverse events related to the gel have been reported. ^{1 3 4 6 7}

How does the drug Testosterone gel 1.62% differ from other treatments for low testosterone and diabetes?

Testosterone gel 1.62% is unique because it has increased viscosity and reduced volume of application, which improves skin absorption compared to other testosterone gels. This formulation allows for more efficient delivery of testosterone, potentially leading to better outcomes in managing low testosterone and diabetes. ^{3 4 5 8 9}

Research Team

Reina C Villareal, MD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Eligibility Criteria

This trial is for male veterans aged 35-65 with type 2 diabetes and low testosterone (T levels <300 ng/dl). They should have a BMI under 35, an A1C level below 10.5%, and be experiencing symptoms of hypogonadism. Men with severe prostate issues, certain blood conditions, or those on medications affecting bone metabolism are excluded.

Inclusion Criteria

I am between 35 and 65 years old.

I have had diabetes for 15 years or less.

Your A1C level is less than 10.5%.

Exclusion Criteria

I have not taken medications affecting bone health in the last 2 years.

I have prostate issues indicated by a nodule, high PSA, severe symptoms, or I'm on hormone therapy.

I do not have conditions like thyroid issues or liver disease that affect bone health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either testosterone gel 1.62% or placebo for 12 months

12 months

Visits at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Testosterone gel 1.62%

Trial Overview The study tests if testosterone gel improves bone health in men who have both diabetes and low testosterone. Participants will either receive the testosterone gel or a placebo to compare effects on bone quality over time.

Participant Groups

Group I: Testosterone arm Experimental Treatment 1 Intervention

Testosterone gel 1.62%

Group II: Placebo arm Placebo Group 1 Intervention

Matching placebo will be prepared by the Michael DeBakey VA Medical Center Pharmacy.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study of 149 hypogonadal men, the novel testosterone 2% gel (Fortesta™ Gel) effectively restored testosterone levels to the normal range in 77.5% of patients after 90 days, demonstrating its efficacy as a testosterone replacement therapy.

The gel was generally well tolerated, with mild to moderate skin reactions being the most common side effects, and only 1.6% of patients experienced testosterone levels that were higher than the recommended range, indicating a low risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel testosterone 2% gel for the treatment of hypogonadal males. Dobs, AS., McGettigan, J., Norwood, P., et al.[2013]

Testosterone gel 2% (TG) was found to be effective in increasing serum testosterone levels in hypogonadal men, with an 85.5% responder rate after 3 months of treatment in a study involving 180 participants.

The safety profile of TG was acceptable, with fewer subjects experiencing high testosterone levels (Cmax >1500 ng/dl) in the extension study, and no significant safety concerns were noted, including no notable increases in prostate-specific antigen or haematocrit levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. Belkoff, L., Brock, G., Carrara, D., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A novel testosterone 2% gel for the treatment of hypogonadal males. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Testosterone therapy--what, when and to whom? [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

The efficacy, bioavailability and safety of a novel hydroalcoholic testosterone gel 2% in hypogonadal men: results from phase II open-label studies. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Testosterone Treatment in Men: A T4DM Post-Randomisation Observational Follow-Up Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effects of long-term testosterone replacement therapy, with a temporary intermission, on glycemic control of nine hypogonadal men with type 1 diabetes mellitus - a series of case reports. [2015]