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

This study has been completed.
Odense University Hospital
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital
ClinicalTrials.gov Identifier:
First received: March 20, 2012
Last updated: November 13, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Testosterone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Lean body mass [ Time Frame: approximately three years ] [ Designated as safety issue: Yes ]
    Accessed by DXA scanning

Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: three years ] [ Designated as safety issue: No ]
    Euglycemic hyperinsulinaemic clamp

  • Regional body composition and liver fat [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    DXA- and MR-scans and spect

  • Glucose and lipid oxidation [ Time Frame: three years ] [ Designated as safety issue: No ]
    Indirect calorimetry

  • Myostatin and satellite cells [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Muscle biopsy

  • Inflammation [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.

  • Physical activity [ Time Frame: three years ] [ Designated as safety issue: No ]

  • Quality of life [ Time Frame: three years ] [ Designated as safety issue: No ]

  • Sexual function [ Time Frame: Three years ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testim Drug: Testosterone
50 mg/dose/day for 24 weeks
Other Name: Testim
Placebo Comparator: Placebo
Placebo for 24 weeks
Drug: Placebo
placebo on the skin for 24 weeks

Detailed Description:
Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male gender age 50-70
  • Bioavailable testosterone < 7,3 nmol/L
  • Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

  • HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%,
  • Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times,
  • Abnormal routine blood samples,
  • Severe hypertension,
  • Significant EKG-changes,
  • Wish of parenthood,
  • Active mental illness,
  • former or present abuse,
  • Severe illness of heart-, lung- or kidney,
  • Primary or secondary hypogonadism.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01560546

Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Marianne Andersen
Odense University Hospital
Principal Investigator: Marianne Andersen, MD, ph.d.
  More Information

Responsible Party: Marianne Andersen, MD, ph.d., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01560546     History of Changes
Other Study ID Numbers: 2011-002102-73 
Study First Received: March 20, 2012
Last Updated: November 13, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Gonadal Disorders
Metabolic Diseases
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016