Trial reportDiabetes care2011
Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study).
Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 188 papers, 17 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
188 citing papers in PubMed, 17 syntheses or guidelines pooled it, 535 citations in OpenAlex.
- Cardiovascular safety in middle-aged and older men under testosterone replacement therapy: a systematic review and meta-analysis.Endocrine · 2026Pooled it
- Metabolic Effects of Testosterone Replacement Therapy in Men with Functional Secondary Hypogonadism, Obesity and Type 2 Diabetes or Metabolic Syndrome: A Systematic Review.Medical sciences (Basel, Switzerland) · 2026Pooled it
- The effects and safety of testosterone replacement therapy for men with hypogonadism: the TestES evidence synthesis and economic evaluation.Health technology assessment (Winchester, England) · 2024Pooled it
- Adult- and late-onset male hypogonadism: the clinical practice guidelines of the Italian Society of Andrology and Sexual Medicine (SIAMS) and the Italian Society of Endocrinology (SIE).Journal of endocrinological investigation · 2022Guideline
- Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis.The lancet. Healthy longevity · 2022Pooled it
- The effect of different administrations of testosterone therapy on adverse prostate events: A Bayesian network meta-analysis.Frontiers in endocrinology · 2022Pooled it
- Efficacy of testosterone replacement therapy for treating metabolic disturbances in late-onset hypogonadism: a systematic review and meta-analysis.International urology and nephrology · 2021Pooled it
- The effects of testosterone on bone health in males with testosterone deficiency: a systematic review and meta-analysis.BMC endocrine disorders · 2020Pooled it
- Effects of testosterone supplement treatment in hypogonadal adult males with T2DM: a meta-analysis and systematic review.World journal of urology · 2018Pooled it
- Pooled it
- Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology.Journal of endocrinological investigation · 2015Pooled it
- Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis.BMC medicine · 2014Pooled it
- The effect of testosterone replacement therapy on prostate cancer: a systematic review and meta-analysis.Prostate cancer and prostatic diseases · 2014Pooled it
- Endogenous sex hormones, metabolic syndrome, and diabetes in men and women.Current cardiology reports · 2014Pooled it
- Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.BMC medicine · 2013Pooled it
- The effect of statins on testosterone in men and women, a systematic review and meta-analysis of randomized controlled trials.BMC medicine · 2013Pooled it
- Metabolic effects of testosterone replacement therapy on hypogonadal men with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.Asian journal of andrologyPooled it
- The effect of testosterone therapy on erectile dysfunction in type 2 diabetic patients.International urology and nephrology · 2026Trial
- Semaglutide improved sperm morphology in obese men with type 2 diabetes mellitus and functional hypogonadism.Diabetes, obesity & metabolism · 2025Trial
- Baseline Testosterone Predicts Body Composition and Metabolic Response to Testosterone Therapy.Frontiers in endocrinology · 2022Trial
128 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
12 authors at 7 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS). RESEARCH DESIGN AND
methodsThe 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/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12).
resultsTRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA(1c): treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate.
conclusionsOver a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.