NCT00613782

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. 1.Body composition and bone mineral density by DEXA
  2. 2.Body composition by magnetic resonance imaging
  3. 3.Bony micro-architecture by high resolution quantitative computed tomography \[HR-pQCT\]),
  4. 4.Cardiac dimensions and function by transthoracic doppler echocardiography

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2012

Enrollment Period

5 years

First QC Date

January 31, 2008

Last Update Submit

June 30, 2014

Conditions

Type 2 DiabetesHypogonadism

Outcome Measures

Primary Outcomes (1)

  • Insulin Resistance

    40 weeks

Secondary Outcomes (1)

  • Bone microarchitecture

    40 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Reandron 100 treatment

Drug: Reandron 1000

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Reandron 1000DRUG

1000mg at 0,6,18,30 weeks

Also known as: testosterone undecanoate
1
placeboDRUG

placebo injection 0,6.18.30 weeks

2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication to
  • Testosterone or
  • IM injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (1)

  • 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.

    PMID: 24978674DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Mathis Grossmann

    Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AProf

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

July 1, 2014

Record last verified: 2012-06

Locations

AU(1)