SOURCE-LINKED STUDY SUMMARY
Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial.
Abstract summarizedQuality not appraised
- What was studied
- T4DM: double-blind randomized phase 3b trial tested testosterone added to a lifestyle programme for diabetes prevention or reversal.
- Who / model studied
- 1007 men aged 50–74 with abdominal obesity, testosterone ≤14 nmol/L, and impaired glucose tolerance or newly diagnosed diabetes; pathological hypogonadism excluded.
- Studied dose & schedule
- Testosterone undecanoate 1000 mg intramuscularly versus placebo at baseline, 6 weeks, then every 3 months for 2 years; both groups received lifestyle support.
- What the study found
- At 2 years, diabetes-range OGTT results occurred in 55/443 (12%) testosterone versus 87/413 (21%) placebo participants with data: RR 0.59 (95% CI 0.43–0.80). Hematocrit >54% triggered action in 22% versus 1%; serious adverse events occurred in 10.9% versus 7.4%.
- Limitations & context
- Abstract assessment. Hematocrit increases may limit treatment; longer-term durability, cardiovascular effects and safety remain unresolved.
Read summary source ↗ · Prepared 10/6/2026 · AI-assisted, source-based summary
Review record & corrections
Summary prepared: . Source scope: abstract. This is an AI-assisted source summary, not an independent clinician sign-off.
No public field-by-field revision history is available for this card yet. The date above is the summary date, not proof that every field was updated then.
Inspect the source · Correction policyResearch findings apply to the population and conditions studied. This educational summary is not a treatment recommendation or a formal assessment of study quality.
Original publication ↗ · DOI: 10.1016/s2213-8587(20)30367-3