parallel randomized trial

ADJUST-T1D

Efficacy and Safety of Once Weekly Semaglutide in Adults With Obesity and Inadequately Controlled Type 1 Diabetes Using Hybrid Closed-Loop System.

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide	automated insulin delivery; lifestyle: not reported	36	36
A2	Placebo Placebo	automated insulin delivery; lifestyle: not reported	36	36

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	Placebo A2
age	mean (years)	41.4	38.9
age	sd (years)	11.6	13.1
asian	n	0	1
black	n	3	3
black	percent	8.3	8.3
bmi	mean (kg/m2)	34.7	36.0
bmi	sd (kg/m2)	3.9	5.2
diabetes duration	mean (years)	23.4	21.9
diabetes duration	sd (years)	11.2	11.6
female	n	22	20
female	percent	61.1	55.6
hba1c	mean (percent)	7.8	7.7
hba1c	sd (percent)	0.6	0.6
hispanic	n	1	4
hispanic	percent	2.7	11.1
insulin dose	mean (U/kg/day)	0.7	0.7
insulin dose	sd (U/kg/day)	0.2	0.3
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	0	0
other race other	n	0	3
other race other	percent		8.3
weight	mean (kg)	99.5	104.5
weight	sd (kg)	14.6	16.3
white	n	33	30
white	percent	91.7	83.3

24 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
26	A1	change	-0.7 percent	0.1		36	not stated; randomized; registry:outcomes
26	A2	change	-0.4 percent	0.1		36	not stated; randomized; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 36	not stated; randomized; registry:outcomes
	A2	events				2 / 36	not stated; randomized; registry:outcomes

Total daily insulin dose change (10 lines; O06)

Week	Arm	Statistic	Estimate	95% CI	Detail
20	A1	change	-15.2 U/day	-19.8 to -10.7	not stated; other; R0014665:Results
20	A1	final	0.62 U/kg/day	0.54 to 0.70	not stated; other; R0014665:Results
20	A1	percent change	-19.1 percent	-24.7 to -13.5	not stated; other; R0014665:Results
20	A1 vs A2	md	-18.0 U/day	-23.5 to -12.2	not stated; other; R0014665:Results
26	A1	change	-17.4 U/day	-22.0 to -12.9	not stated; other; R0014665:Results
26	A1	final	0.60 U/kg/day	0.52 to 0.69	not stated; other; R0014665:Results
26	A1	percent change	-22.6 percent	-28.3 to -17.0	not stated; other; R0014665:Results
26	A1 vs A2	md	-21.9 U/day	-27.5 to -16.1	not stated; other; R0014665:Results
26	A2	change	5.2 U/day	0.7 to 9.7	not stated; other; R0014665:Results
26	A2	percent change	7.1 percent	1.5 to 12.7	not stated; other; R0014665:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 36	not stated; safety; registry:adverse_events
	A2	events				0 / 36	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 36	not stated; safety; nausea & vomiting; registry:adverse_events
	A2	events				0 / 36	not stated; safety; nausea & vomiting; registry:adverse_events

Diabetic ketoacidosis (2 lines; O30)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0014665:Conclusions
	A2	events				0 /	not stated; other; R0014665:Conclusions

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 36	not stated; randomized; registry:outcomes
	A2	events				2 / 36	not stated; randomized; registry:outcomes

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 36	not stated; safety; registry:adverse_events
	A2	events				0 / 36	not stated; safety; registry:adverse_events