Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)

Author:

Jones T. Hugh12,Arver Stefan3,Behre Hermann M.4,Buvat Jacques5,Meuleman Eric6,Moncada Ignacio7,Morales Antonio Martin8,Volterrani Maurizio9,Yellowlees Ann10,Howell Julian D.11,Channer Kevin S.12,

Affiliation:

1. The Robert Hague Centre for Diabetes and Endocrinology, Barnsley Hospital, Barnsley, U.K.

2. Department of Human Metabolism, School of Medicine and Biomedical Science, University of Sheffield, Sheffield, U.K.

3. Center for Andrology and Sexual Medicine, Karolinska University Hospital and the Karolinska Institute, Stockholm, Sweden

4. Center for Reproductive Medicine and Andrology, University Hospital Halle (Saale), Martin-Luther University Halle-Wittenberg, Halle, Germany

5. Centre d’Etudes et de Traitement de la Pathologie de l’Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France

6. Department of Urology, VU University Medical Center, Amsterdam, the Netherlands

7. Department of Urology, Hospital Sanitas-La Zarzuela, Madrid, Spain

8. Department of Urology, Carlos Haya University Hospital, Malaga, Spain

9. Department of Cardiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy

10. Quantics Consulting Limited, Tweed Horizons, Newtown St Boswells, Scottish Borders, U.K.

11. Clinical Research Department, ProStrakan, Galashiels, U.K.

12. Department of Cardiology, Royal Hallamshire Hospital, Sheffield, U.K.

Abstract

OBJECTIVE This 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 METHODS The 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). RESULTS TRT 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 (HbA1c: 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. CONCLUSIONS Over 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.

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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