Reandron in Diabetic Men Witn Low Testosterone Level
Condition: Type 2 Diabetes; Hypogonadism
MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In men with type 2 diabetes, low testosterone levels have been associated with insulin
      resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low
      testosterone may impair cardiac function and increase cardiovascular risk and cause
      osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2
      diabetes mellitus and low testosterone levels, testosterone replacement improves insulin
      resistance, body composition, bone density, cardiac function symptoms associated with low
      testosterone level.

      The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum
      testosterone level (<10 nmol/L) from Austin Health Endocrine clinics, General Practise
      surgeries, and from the general public by direct consumer advertising via newspaper and other
      local media. Men will be randomised to either intramuscular testosterone undecanoate
      (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone
      replacement or to intramuscular injections will be excluded from the study. All men will
      receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of
      four injections).

      All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks
      and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and
      at study end (40 weeks). The study protocol is outlined in more detail below:

      Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical
      history and physical examination will be performed. Symptoms will be assessed by the
      following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2)
      Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4)
      International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached
      to Module 1).

      Laboratory studies will consist of blood tests to measure total testosterone, fasting
      glucose, C-peptide, HBA1c and other routine parameters.

      Imaging studies (Baseline and repeated at 40 weeks)

        1. Body composition and bone mineral density by DEXA

        2. Body composition by magnetic resonance imaging

        3. Bony micro-architecture by high resolution quantitative computed tomography [HR-pQCT]),

        4. Cardiac dimensions and function by transthoracic doppler echocardiography
    


Intervention name(s): Reandron 1000; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000mg at 0,6,18,30 weeks; placebo injection 0,6.18.30 weeks
Other intervention name(s): testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment