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

Marianne Andersen

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Hypogonadism

Treatments: Drug: Testosterone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01560546

2011-002102-73

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

43 participants in 2 patient groups, including a placebo group

Testim

Active Comparator group

Treatment:

Drug: Testosterone

Placebo

Placebo Comparator group

Description:

Placebo for 24 weeks

Treatment:

Drug: Placebo