MedTrace Logo

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

NCT01560546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-11-14

No results posted yet for this study

Summary

A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.

Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.

Conditions

Interventions

DRUG

Testosterone

50 mg/dose/day for 24 weeks

DRUG

Placebo

placebo on the skin for 24 weeks

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Marianne Andersen

    lead OTHER

Principal Investigators

  • Marianne Andersen, MD, ph.d.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560546 on ClinicalTrials.gov