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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how testosterone gel can improve bone health in male veterans with low testosterone and type 2 diabetes. Both conditions increase fracture risk, yet no specific treatment exists for bone disease in people with diabetes. The study compares testosterone gel with a placebo to determine its effectiveness. Men with type 2 diabetes for 15 years or less, experiencing symptoms like low energy or decreased libido, might be suitable candidates. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

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 is the safety track record for testosterone gel 1.62%?

Research has shown that testosterone gel 1.62% is generally safe. One study found that participants tolerated the gel well for up to one year, with most not experiencing serious side effects. However, some individuals might have mild reactions, such as skin irritation at the application site.

The FDA has updated labels on testosterone products to include information about possible heart-related risks. While the gel is safe for many, some individuals might need to exercise caution.

Overall, testosterone gel has been shown to be safe for many users, but discussing personal health risks with a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for low testosterone and diabetes that often involve injectable testosterone, this treatment uses a testosterone gel applied directly to the skin. This unique delivery method allows for more consistent hormone levels, which might improve blood sugar control in diabetic patients. Researchers are excited because this could provide a more convenient and potentially safer option, reducing the need for frequent doctor visits for injections.

What evidence suggests that testosterone gel might be an effective treatment for bone health in men with low testosterone and diabetes?

In this trial, participants will be assigned to either the Testosterone arm or the Placebo arm. Research has shown that testosterone gel 1.62%, which participants in the Testosterone arm will receive, effectively treats low testosterone. In earlier studies, men with low testosterone who used the gel experienced a rise in their levels to normal within 30 minutes, with these improvements lasting over time. Evidence also suggests that testosterone therapy can improve the body's ability to manage sugar and lower blood sugar levels. Although this gel hasn't been specifically tested for bone health in men with both low testosterone and diabetes, it has shown benefits in related areas. Since this trial is in Phase 4, testosterone gel is already proven effective for low testosterone. ^{1 2 3 6 7}

Who Is on the Research Team?

Reina C Villareal, MD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3064036/

Testosterone Replacement in Hypogonadal Men With Type 2 ... The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/ ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609515339552

One‐Year Efficacy and Safety Study of a 1.62% ... 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.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/andr.13779

Single‐arm study of testosterone gel replacement therapy ... While the effect of testosterone gel 1.62% on 24-h average SBP could not be ruled out based on the study's non-inferiority margin, the clinical ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003855

Update to the Testosterone Guideline Results demonstrated several notable findings, including better glucose tolerance (relative risk 0.59, P < .001) and improved 2-hour glucose (∼ ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2785864/

Safety and efficacy of testosterone gel in the treatment ... After the first application of Androgel to hypogonadal men, serum testosterone levels rose into the normal range within 30 min followed by a gradual rise ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/022309s008lbl.pdf

AndroGel 1.62% - accessdata.fda.gov ANDROGEL 1.62%. It is not known if AndroGel 1.62% is safe or effective to treat men who have low testosterone due to aging. It is not known if ANDROGEL 1.62 ...

7. secure.medicalletter.org secure.medicalletter.org/TML-article-1726d

In Brief: Label Changes for Testosterone Products The FDA has required changes in the labels of all testosterone products to reflect new data on their cardiovascular effects.