NCT06489457

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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)).

Conditions

• Type 2 Diabetes Mellitus
• Obesity
• Functional Hypogonadism

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide subcutaneous injection once weekly titrated to 1 mg in concordance with Summary of product characteristics (SmPC) (0.25 mg once weekly in the first month, 0.5 mg once weekly in the second month and 1 mg once weekly from the third month onward)
DRUG	Testosterone Undecanoate	Testosterone Undecanoate intramuscular injection 1000 mg once per 10-12 weeks

Timeline

• Start date: 2020-09-20
• Primary completion: 2023-05-11
• Completion: 2023-06-30
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: Slovenia