parallel randomized trial

NCT06475586

Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus

Design

Randomized: 31
Start year: 2023
Treatment: 12 weeks, follow-up 12 weeks
Countries: Bosnia and Herzegovina (1 sites)
Sponsor: University of Banja Luka (non industry)
Eligibility: age 18 to 70; T2D on metformin; PASI 10 or higher; BMI above 30 and HbA1c above 7

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg plus metformin	metformin; lifestyle: standard	15	13
A2	Standard care or no added treatment Control, metformin only	metformin; lifestyle: standard	16	15

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	Standard care or no added treatment A2
age	mean (years)	58.6	57.4
age	sd (years)	8.04	13.02
bmi	mean (kg/m2)	35.04	36.2
bmi	sd (kg/m2)	5.9	7.7
female	n	3	3
female	percent	20	18.75
hba1c	median (percent)	7.3	4.95

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
12	A1	final	percent				not stated; completers; R0012971:Table 2
12	A2	final	percent				not stated; completers; R0012971:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	final	points				not stated; completers; R0012971:Results
12	A2	final	points				not stated; completers; R0012971:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 15	not stated; randomized; R0012971:Results

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 15	not stated; randomized; R0012971:Results