PEDEvidence

SOURCE-LINKED STUDY SUMMARY

Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study).

Diabetes care ·

Human

Full paper summarizedQuality not appraised
What was studied
TIMES2 tested testosterone replacement effects on insulin resistance, metabolic risk factors, body composition, symptoms, safety, and tolerability.
Who / model studied
The multicenter trial randomized 220 hypogonadal men with type 2 diabetes and/or metabolic syndrome.
Studied dose & schedule
Participants applied 2% testosterone gel 60 mg daily, adjustable to 40–80 mg, or placebo for 12 months.
What the study found
Versus placebo, HOMA-IR improved 15.2% at six months and 16.4% at 12 months. Adverse-event and serious-adverse-event frequencies did not significantly differ; most events were mild or moderate.
Limitations & context
Only 54% completed 12 months. Medication changes were allowed after month six, secondary outcomes were exploratory without multiplicity adjustment, and body composition used bioelectrical impedance rather than direct muscle imaging.

Read summary source ↗ · Prepared 10/6/2026 · AI-assisted, source-based summary

Review record & corrections

Summary prepared: . Source scope: full paper. 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.

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Research 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: 10.2337/dc10-1233

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