A Phase 3 interventional study of Semaglutide and Testosterone Undecanoate in Type 2 Diabetes Mellitus, Obesity and Functional Hypogonadism, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by University Medical Centre Ljubljana · Phase 3, Interventional, and Treatment
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:
The researchers will compare semaglutide to testosterone replacement to see which drug better treats symptoms of hypogonadism.
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.
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)).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Drug: Semaglutide
Drug: Testosterone Undecanoate
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)
Testosterone Undecanoate intramuscular injection 1000 mg once per 10-12 weeks
Change in semen volume from baseline and between the treatment arms
The semen volume will be measured and reported in mililiters (mL). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in sperm concentration from baseline and between the treatment arms
The sperm concentration will be measured and reported in number times 10\^6 per mililiter (10\^6/mL). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in total motility of sperm from baseline and between the treatment arms
The total motility will be assessed as total number of motile sperm and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in normal sperm forms from baseline and between the treatment arms
The normal sperm forms will be assessed as total number of sperm with normal morphology and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in total number of sperm from baseline and between the treatment arms
The total number of sperm will be measured and reported in number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in International index of erectile function 15 (IIEF-15) score from baseline and between the treatment arms
IIEF-15 assesses male sexual function. It has 5 domains. Erectile function with scoring range from 30 (max) to 1 (min). Orgasmic function with scoring range from 10 (max) to 1 (min). Sexual desire with scoring range from 10 (max) to 2 (min). Intercourse satisfaction with scoring range from 15 (max) to 0 (min). Overall satisfaction with scoring range from 10 (max) to 2 (min). The subdomains combine to overall score with scoring range from 75 (max) to 6 (min). The higher score indicates the better sexual function.
Time frame: Baseline and 24 weeks
Change in Aging male symptoms (AMS) score from baseline and between the treatment arms
The AMS score assesses male symptoms os hypogonadism. It has 3 subdomains. Psychological symptoms with scoring range from 25 (max) to 5 (min). Somatic with scoring range from 35 (max) to 7 (min). Sexual with scoring range from 25 (max) to 5 (min). The subdomains combine to overall score with scoring range from 85 (max) to 17 (min). The lower the score the less symptoms are present.
Time frame: Baseline and 24 weeks
Change in HbA1c from baseline and between the treatment arms
The HbA1c will be measured and reported in % and milimoles per mole (mmol/mol). The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in follicle-stimulating hormone (FSH) from baseline and between the treatment arms
The FSH will be measured and reported in international units per liter (IU/L). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in luteinizing hormone (LH) from baseline and between the treatment arms
The LH will be measured and reported in international units per liter (IU/L). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in estimated visceral adipose tissue from baseline and between the treatment arms
Measured by dual-energy X-ray absorptiometry the estimated visceral adipose tissue will be reported in grams (g). The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in percentage of body fat from baseline and between the treatment arms
Measured by dual-energy X-ray absorptiometry the procentage of body fat will be reported in %. The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in fasting serum low-density lipoproteins (LDL) cholesterol from baseline and between the treatment arms
The LDL cholesterol will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in fasting serum total cholesterol from baseline and between the treatment arms
The total cholesterol will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in fasting serum high-density lipoproteins (HDL) cholesterol from baseline and between the treatment arms
The HDL cholesterol will be measured and reported in milimoles per liter (mmol/L). The higher the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in fasting triglycerides from baseline and between the treatment arms
Triglycerides will be measured and reported in milimoles per liter (mmol/L). The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in body mass from baseline and between the treatment arms
The body mass will be assessed and reported in kilograms (kg). The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in body mass index (BMI) from baseline and between the treatment arms
The BMI will be calculated from body mass and height using the following equation: BMI=body mass in kilograms (kg) divided by height in meters (m) squared, and reported in kg/m\^2. The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score from baseline and between the treatment arms
The HOMA-IR will be calculated using the following equation: HOMA-IR = (fasting plasma insulin×fasting plasma glucose)/22.5. The lower the value the better the outcome.
Time frame: Baseline and 24 weeks
Plan to share: No — We have not decided how and when IPD and the supporting information will be shared. The documents also need to be translated into English. It might take some time.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University Medical Centre Ljubljana