parallel randomized trial

SEMAT

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

Type 2 diabetes (adults)NCT06489457S000079

Design

Randomized: 25
Start year: 2020
Treatment: 24 weeks, follow-up 24 weeks
Countries: Slovenia (1 sites)
Sponsor: University Medical Centre Ljubljana (non industry)
Eligibility: men 18 to 65; type 2 diabetes on oral agents; BMI above 30; functional hypogonadism with testosterone below 11 nmol/L

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1 mg	metformin 1000 mg twice daily with or without sulfonylurea; lifestyle: standard	13	13
A2	Testosterone Testosterone undecanoate	metformin 1000 mg twice daily with sulfonylurea or DPP-4 inhibitor; lifestyle: standard	12	12

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Testosterone A2	Whole trial ALL
age	median (years)			50
age	q1 (years)			46.1
age	q3 (years)			59.7
bmi	median (kg/m2)	35.9	35.8
bmi	q1 (kg/m2)	32.8	32.7
bmi	q3 (kg/m2)	38.7	39.9
diabetes duration	mean (years)			4
hba1c	median (percent)	7.1	7.2
hba1c	q1 (percent)	6.7	6.8
hba1c	q3 (percent)	8	8.0
metformin use	percent			100
other hypertension	percent			68
other male	n			25
other sulfonylurea use	percent			60
weight	median (kg)	115	111.5
weight	q1 (kg)	102	101.7
weight	q3 (kg)	120	125.2

Analyses this trial contributes to

Results

6 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	percent			13	not stated; randomized; R0019948:Table 1
24	A2	change	percent			12	not stated; randomized; R0019948:Table 1

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	kg			13	not stated; randomized; R0019948:Table 1
24	A2	change	kg			12	not stated; randomized; R0019948:Table 1

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	points			13	not stated; randomized; R0019948:Table 3
24	A2	change	points			12	not stated; randomized; R0019948:Table 3