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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]

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

Hypogonadism

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Insulin Resistance

Timepoint [1]

40 weeks

Secondary outcome [1]

Bone microarchitecture

Timepoint [1]

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?

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

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Melbourne

Recruitment postcode(s) [1]

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

Mathis Grossmann

Address

Austin Health

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00613782

Trial Review

Registering a new trial?

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