Reandron in Diabetic Men With Low Testosterone Level - ...

Reandron in Diabetic Men With Low Testosterone Level

Reandron in Diabetic Men With Low Testosterone Level
This study is currently recruiting participants.
Verified by Austin Health, January 2009

Sponsored by: Austin Health
Information provided by: Austin Health
ClinicalTrials.gov Identifier: NCT00613782

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:
Hypogonadism
Type 2 Diabetes

Intervention:
Drug: Reandron 1000
Drug: placebo

Phase:
Phase II
Phase III

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

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 ]


Estimated Enrollment: 140
Study Start Date: January 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Arms
1: Active Comparator - Reandron 100 treatment
Assigned Interventions: Drug: Reandron 1000
1000mg at 0,6,18,30 weeks
2: Placebo Comparator - Placebo
Assigned Interventions: Drug: placebo
placebo injection 0,6.18.30 weeks

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
* Tesosterone less than 10 nmol/L

Exclusion Criteria:

* Contraindication to
* Testosterone or
* IM injection

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

Contacts
Contact: Mathis Grossmann 61394965477
Contact: Jeffrey D Zajac 61394965477

Locations:
Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia, 3084

Principal Investigator: Mathis Grossmann

Sponsors and Collaborators
Austin Health

Investigators
Principal Investigator: Mathis Grossmann (Austin Health)

More Information

Responsible Party: Austin Health ( Dr. Mathis Grossmann or Professor Jeffrey D. Zajac )
Study ID Numbers: Reandron 1000 (ZK 5488) 321399
Study First Received: January 31, 2008
Last Updated: January 16, 2009
ClinicalTrials.gov Identifier: NCT00613782
Health Authority: Australia: Human Research Ethics Committee

ClinicalTrials.gov processed this record on March 06, 2009