Testosterone gel 1.62% for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Type 2 Diabetes Mellitus+3 More
Testosterone gel 1.62% - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will test if testosterone can improve the bone health of male veterans who have both low testosterone and diabetes.

Eligible Conditions
  • Type 2 Diabetes Mellitus
  • Hypogonadism

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Type 2 Diabetes Mellitus

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 5 years

5 years
Bone and Bones
Markers of bone turnover to measure bone metabolism
Osteoblast and osteoclast progenitor cells which are cells found in bone

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Type 2 Diabetes Mellitus

Side Effects for

Testosterone
19%Skin irritation
10%Increased facial hair
5%Acne
5%per vagina spotting
5%Blepharitis
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT01208038) in the Testosterone ARM group. Side effects include: Skin irritation with 19%, Increased facial hair with 10%, Acne with 5%, per vagina spotting with 5%, Blepharitis with 5%.

Trial Design

2 Treatment Groups

Testosterone arm
1 of 2
Placebo arm
1 of 2
Experimental Treatment
Non-Treatment Group

166 Total Participants · 2 Treatment Groups

Primary Treatment: Testosterone gel 1.62% · Has Placebo Group · Phase 4

Testosterone arm
Drug
Experimental Group · 1 Intervention: Testosterone gel 1.62% · Intervention Types: Drug
Placebo arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,472 Previous Clinical Trials
2,741,528 Total Patients Enrolled
4 Trials studying Type 2 Diabetes Mellitus
2,405 Patients Enrolled for Type 2 Diabetes Mellitus
Reina C. Villareal, MDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an average fasting morning T level of <300 ng/dl.
You are a male veteran between the ages of 18 and 65.
You have an A1C of <10.
You have a body mass index (BMI) of less than 35 kg/m2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas60.0%
Florida40.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
References