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Reandron in Diabetic Men Witn Low Testosterone Level

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ClinicalTrials.gov Identifier: NCT00613782
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):
Mathis Grossmann, Austin Health

Brief 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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Hypogonadism Drug: Reandron 1000 Drug: placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels
Study Start Date : January 2009
Primary Completion Date : January 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Reandron 100 treatment
Drug: Reandron 1000
1000mg at 0,6,18,30 weeks
Other Name: testosterone undecanoate
Placebo Comparator: 2
Drug: placebo
placebo injection 0,6.18.30 weeks

Primary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 40 weeks ]

Secondary Outcome Measures :
  1. Bone microarchitecture [ Time Frame: 40 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes
  • Testosterone less than 10 nmol/L

Exclusion Criteria:

  • Contraindication to
  • Testosterone or
  • IM injection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613782

Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Principal Investigator: Mathis Grossmann Austin Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mathis Grossmann, AProf, Austin Health
ClinicalTrials.gov Identifier: NCT00613782     History of Changes
Other Study ID Numbers: Reandron 1000 (ZK 5488) 321399
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2012

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents