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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00613782




Registration number
NCT00613782
Ethics application status
Date submitted
31/01/2008
Date registered
13/02/2008
Date last updated
1/07/2014

Titles & IDs
Public title
Reandron in Diabetic Men Witn Low Testosterone Level
Scientific title
Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels
Secondary ID [1] 0 0
Reandron 1000 (ZK 5488) 321399
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Hypogonadism 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Reandron 1000
Treatment: Drugs - placebo

Active comparator: 1 - Reandron 100 treatment

Placebo comparator: 2 - Placebo


Treatment: Drugs: Reandron 1000
1000mg at 0,6,18,30 weeks

Treatment: Drugs: placebo
placebo injection 0,6.18.30 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insulin Resistance
Timepoint [1] 0 0
40 weeks
Secondary outcome [1] 0 0
Bone microarchitecture
Timepoint [1] 0 0
40 weeks

Eligibility
Key inclusion criteria
* Type 2 diabetes
* Testosterone less than 10 nmol/L
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to
* Testosterone or
* IM injection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00613782
Trial related presentations / publications
Gianatti EJ, Dupuis P, Hoermann R, Zajac JD, Grossmann M. Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3821-8. doi: 10.1210/jc.2014-1872. Epub 2014 Jun 30.
Public notes

Contacts
Principal investigator
Name 0 0
Mathis Grossmann
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00613782