Trial | NCT01560546  Report issue

Title

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    testosterone ...

  • Study Participants

    43
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.
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.
Study Started
Mar 31
2012
Primary Completion
May 31
2013
Study Completion
Nov 30
2013
Last Update
Nov 14
2013
Estimate

Drug Testosterone

50 mg/dose/day for 24 weeks

  • Other names: Testim

Drug Placebo

placebo on the skin for 24 weeks

Testim Active Comparator

Placebo Placebo Comparator

Placebo for 24 weeks

Criteria 

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.
No Results Posted