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Testosterone therapy in men with type 2 diabetes and low bioavailable testosterone
2011-002102-73Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2011
- Countries
- 1
- Sponsor
- Department of Endocrinology M (Odense University Hospital)
- Modality
- Small Molecules
- Drugs
- testosterone
- Conditions
- Hypoandrogenism (TD)
01
Overview
Phase 4, single-arm trial of testosterone in Hypoandrogenism (TD), sponsored by Department of Endocrinology M (Odense University Hospital). Primary endpoint: Lean body mass. Started Dec 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedSingle group
Testim testosterone treatment
Men with type 2 diabetes mellitus and low bioavailable testosterone receiving testosterone gel therapy.
03
Who it enrols
Men aged 50-70 years with relatively recent type 2 diabetes mellitus on metformin for at least 3 months and low bioavailable testosterone (<7.3 nmol/L), excluding poorly controlled diabetes, major comorbidity, malignancy, significant prostate risk markers, major psychiatric illness, recent substance abuse, and primary or secondary hypogonadism.
04
Endpoints
Primary
Lean body mass
Secondary
Insulin sensitivity
Liver lipid content
Adiponectin level
C-reactive protein level
Quality of life
Physical activity
Muscle satellite cell number
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