Reandron in Diabetic Men Witn Low Testosterone Level

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mathis Grossmann, Austin Health
ClinicalTrials.gov Identifier:
NCT00613782
First received: January 31, 2008
Last updated: June 30, 2014
Last verified: June 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes
Hypogonadism
Drug: Reandron 1000
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels

Resource links provided by NLM:


Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone microarchitecture [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2009
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Reandron 100 treatment
Drug: Reandron 1000
1000mg at 0,6,18,30 weeks
Other Name: testosterone undecanoate
Placebo Comparator: 2
Placebo
Drug: placebo
placebo injection 0,6.18.30 weeks
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to
  • Testosterone or
  • IM injection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613782

Locations
Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: Mathis Grossmann Austin Health
  More Information

No publications provided

Responsible Party: Mathis Grossmann, AProf, Austin Health
ClinicalTrials.gov Identifier: NCT00613782     History of Changes
Other Study ID Numbers: Reandron 1000 (ZK 5488) 321399
Study First Received: January 31, 2008
Last Updated: June 30, 2014
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 01, 2014