Phase 4
N=49
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00350701 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo — 100; 100; 100; 236 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- androgel (Drug); androgel 10g (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- University at Buffalo
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo |
100; 100; 100; 236; 82; 100 | — |
| SECONDARY Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo |
100; 100; 100; 91; 125; 110 | — |
| SECONDARY Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone |
100; 100; 100; 68; 130; 95 | — |
Summary
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
Eligibility Criteria
Inclusion Criteria
- Males with age 35-75 years inclusive.
- Evidence of hypogonadism: low free testosterone.
- Type 2 Diabetes
- People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
- If currently on testosterone replacement, testosterone treatment will be held for 8 weeks.
- BP under control even if on medication.
Exclusion Criteria
- Coronary event or procedure in previous past 4 wks.
- High PSA
- H/O prostate cancer
- Hepatic or renal disease
- Participation in any other concurrent clinical trial
- Any other life- threatening , non cardiac disease.
- Uncontrolled BP
- Congestive heart failure
- High hemoglobin
- Use of investigational agent or therapeutic regimen within 30 days of study.
Data sourced from ClinicalTrials.gov (NCT00350701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.