The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity (SEMAT)

University Medical Centre Ljubljana

Status and phase

Completed

Phase 3

Conditions

Functional Hypogonadism

Type 2 Diabetes Mellitus

Obesity

Treatments

Drug: Semaglutide

Drug: Testosterone Undecanoate

Study type

Interventional

Funder types

Other

Identifiers

NCT06489457

0120-26/2020/13 (Other Identifier)

SEMA-TESTO Hypogonadism

Details and patient eligibility

About

The goal of this study is to learn whether semaglutide (treatment for type 2 diabetes and obesity) can improve signs and symptoms of hypogonadism in men with type 2 diabetes, obesity and hypogonadism (a condition when levels of testosterone are decreased).

The main questions the study aims to answer are:

Does semaglutide improve the quality of sperm?
Does semaglutide improve symptoms of hypogonadism as well as testosterone replacement?

The researchers will compare semaglutide to testosterone replacement to see which drug better treats symptoms of hypogonadism.

The participants will receive testosterone replacement therapy (intramuscular injection every 10-12 weeks) or magnitude (subcutaneous injection once a week).
The treatment will last 24 weeks.
The participants will visit the clinic at the start and the end of the study.

At the visit, the researchers will measure body weight and take a few blood samples. The participants will also be asked to complete several questionnaires and collect a sperm sample.

The participants are free to terminate their participation in the study at any time without giving a reason.

Full description

Men aged 18 - 65 years with type 2 diabetes on oral antidiabetic treatment, body mass index above 30 kg/m2 and functional hypogonadism (total testosterone below 11 nmol/L and at least 2 symptoms of hypogonadism) are eligible to participate in the study. The participants are randomized to either testosterone undecanoate (100 mg intramuscular injection once per 10-12 weeks) or semaglutide (subcutaneous injection once weekly titrated to 1 mg in concordance with Summary of product characteristics (SmPC) for 24 weeks.

At the beginning of the study and after 24 weeks of treatment the researchers measured anthropometric (body weight, body composition), endocrine (total testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), sex hormone binding globulin (SHBG)) and metabolic parameters (HbA1c, 75-g oral glucose tolerance test (OGTT), insulin, c-peptide). The participants also gave sperm samples and completed self-reported hypogonadism symptom evaluation (Ageing male symptoms (AMS) score, International Index of erectile function 15 (IIEF-15)).

Enrollment

25 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

type 2 diabetes mellitus,
obesity (body mass index (BMI) higher or equal to 30 kg/m^2),
functional hypogonadism (defined by total testosterone less than 11 nmol/L and 2 or more symptoms of sexual dysfunction)

Exclusion criteria

Insulin treatment,
glucagon-like peptide 1 (GLP-1) agonist treatment,
sodium-glucose cotransporter-2 (SGLT-2) inhibitor treatment,
other identified causes of hypogonadism,
hemochromatosis,
active malignant disease,
thrombophilia,
venous thrombosis within 6 months,
recent acute myocardial infarction or stroke,
prostate-specific antigen (PSA) higher than 3 ng/L,
severe lower urinary tract symptoms with an International Prostate Symptom Score above 19,
severe sleep apnea syndrome,
hematocrit higher than 0.5,
significant kidney or liver disease,
ongoing treatment with opioid analgesics, antipsychotics, glucocorticoids,
alcohol abuse,
severe ongoing mental illness,
personal history of pancreatitis or medullary thyroid carcinoma,
personal or family history of multiple endocrine neoplasia type 2.