crossover randomized trial

SEMA-AP

Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care: a Double-blind, Cross-over, Randomized Controlled Trial

Design

Randomized: 28
Start year: 2022
Treatment: 15 weeks, follow-up 32 weeks
Countries: Canada (1 sites)
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (non industry)
Eligibility: Adults 18 or older; type 1 diabetes 1 year or more; insulin pump 3 months or more; HbA1c 11 percent or less; BMI above 21

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo with automated insulin delivery	insulin pump; research automated insulin delivery in last 4 weeks; lifestyle: not reported	28	24
A2	semaglutide Semaglutide maximum tolerated dose with automated insulin delivery	insulin pump; research automated insulin delivery in last 4 weeks; lifestyle: not reported	28	24

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	45
age	sd (years)	14
bmi: 25 to 29.9	n	7
bmi: 25 to 29.9	percent	25
bmi: 30 to 34.9	n	11
bmi: 30 to 34.9	percent	39
bmi: 35 to 39.9	n	5
bmi: 35 to 39.9	percent	18
bmi: 40 or more	n	2
bmi: 40 or more	percent	7
bmi: less than 25	n	3
bmi: less than 25	percent	11
bmi	mean (kg/m2)	32.2
bmi	sd (kg/m2)	5.1
diabetes duration	mean (years)	28
diabetes duration	sd (years)	13
egfr	mean (mL/min/1.73 m2)	97
egfr	sd (mL/min/1.73 m2)	14
female	n	17
female	percent	61
hba1c	mean (percent)	7.4
hba1c	sd (percent)	0.8
insulin dose	mean (U/kg/day)	0.70
insulin dose	sd (U/kg/day)	0.27
sbp	mean (mmHg)	128
sbp	sd (mmHg)	11
waist	mean (cm)	101.1
waist	sd (cm)	14.3
weight	mean (kg)	91.3
weight	sd (kg)	17.4

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	Events / N	Detail
15	A1	final	percent	24	not stated; completers; R0017835:Table 3
15	A1	final	percent	21	not stated; other; R0017835:Supplement Table S6
15	A2	final	percent	24	not stated; completers; R0017835:Table 3
15	A2	final	percent	21	not stated; other; R0017835:Supplement Table S6
15	A2 vs A1	md	-0.5 percent		not stated; completers; R0017835:Table 3
15	A2 vs A1	md	-0.6 percent		not stated; completers; bmi:30_or_more; R0017835:Supplement Table S9
15	A2 vs A1	md	-0.2 percent		not stated; completers; bmi:less_than_30; R0017835:Supplement Table S9

Level 2 or 3 hypoglycemia (participants) (2 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 27	not stated; other; R0017835:Table 4
	A2	events				0 / 28	not stated; other; R0017835:Table 4

Total daily insulin dose change (9 lines; O06)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
15	A1	final	0.77 U/kg/day	0.35	24	not stated; completers; R0017835:Table 2
15	A1	final	U/day		24	not stated; completers; R0017835:Table 2
15	A1	percent change	7.7 percent	25.6	24	not stated; completers; R0017835:Table 2
15	A2	final	0.64 U/kg/day	0.28	24	not stated; completers; R0017835:Table 2
15	A2	final	U/day		24	not stated; completers; R0017835:Table 2
15	A2	percent change	-14.6 percent	23.2	24	not stated; completers; R0017835:Table 2
15	A2 vs A1	md	-0.13 U/kg/day			not stated; completers; R0017835:Table 2
15	A2 vs A1	md	-22.3 percent			not stated; completers; R0017835:Table 2
15	A2 vs A1	md	-11.3 U/day			not stated; completers; R0017835:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0017835:Table 4
	A2	events				1 / 28	not stated; other; R0017835:Table 4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0017835:Results
	A2	events				1 / 28	not stated; randomized; R0017835:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 27	not stated; other; R0017835:Table 4
	A2	events				25 / 28	not stated; other; R0017835:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0017835:Table 4
	A2	events				5 / 28	not stated; other; R0017835:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0017835:Table 4
	A2	events				5 / 28	not stated; other; R0017835:Table 4

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 27	not stated; other; R0017835:Table 4
	A2	events				8 / 28	not stated; other; R0017835:Table 4

Diabetic ketoacidosis (2 lines; O30)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0017835:Table 4
	A2	events				0 / 28	not stated; other; R0017835:Table 4

Severe hypoglycemia (type 1 diabetes) (2 lines; O31)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 27	not stated; other; R0017835:Table 4
	A2	events				0 / 28	not stated; other; R0017835:Table 4

Death by suicide (1 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0017835:Table 4