parallel randomized trial

TRANSITION-T2D

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus (TRANSITION-T2D) A Prospective Randomized Controlled Trial

Type 2 diabetes (adults)NCT04538352S000460

Design

Randomized: 60
Start year: 2021
Treatment: 26 weeks, follow-up 26 weeks
Countries: United States (2 sites)
Sponsor: The Cleveland Clinic (industry)
Eligibility: age 18 to 75; HbA1c 7.5 or lower on basal bolus insulin up to 120 U per day

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: linear mixed model

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Basal bolus insulin Continued basal bolus insulin (degludec plus aspart)	metformin or SGLT2 inhibitor allowed; lifestyle: not reported	20	20
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg plus degludec	insulin degludec with metformin or SGLT2 inhibitor; prandial insulin stopped; lifestyle: not reported	40	40

Baseline characteristics

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

Characteristic	Statistic	Basal bolus insulin A1	Semaglutide 1.0 mg subcutaneous once weekly A2
age	median (years)	64.7	70.1
age	q1 (years)	54.5	62.7
age	q3 (years)	69.3	72.0
asian	n	1	0
asian	percent	5.0	0
black	n	8	12
black	percent	40	30
bmi	median (kg/m2)	35.0	35.3
bmi	q1 (kg/m2)	29.0	30.5
bmi	q3 (kg/m2)	41.0	39.0
diabetes duration	median (years)	16.5	19.0
diabetes duration	q1 (years)	6.8	12.0
diabetes duration	q3 (years)	25.2	25.0
egfr	median (mL/min/1.73 m2)	63.5	66.0
egfr	q1 (mL/min/1.73 m2)	49.8	42.8
egfr	q3 (mL/min/1.73 m2)	84.0	81.6
female	n	8	17
female	percent	40	42
hba1c	median (percent)	6.9	6.8
hba1c	q1 (percent)	6.5	6.2
hba1c	q3 (percent)	7.3	7.2
hispanic	n	0	1
hispanic	percent	0	2.5
insulin dose	median (U/day)	62.5	70.0
metformin use	n	10	19
metformin use	percent	50	48
other race other	n	1	0
other race other	percent	5.0	0
sglt2i use	n	3	6
sglt2i use	percent	15	15
weight	median (kg)	111.6	103.1
weight	q1 (kg)	86.6	89.6
weight	q3 (kg)	122.8	120.6
white	n	10	27
white	percent	50	68

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	0.0 percent	-0.3 to 0.3	20	not stated; randomized; R0018231:Supplement Table S3
26	A2	change	-0.5 percent	-0.7 to -0.3	40	not stated; randomized; R0018231:Supplement Table S3
26	A2 vs A1	md	-0.5 percent	-0.9 to -0.1		not stated; randomized; R0018231:Supplement Table S3

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	1.5 kg	-0.1 to 3.1	20	not stated; randomized; R0018231:Supplement Table S3
26	A1 vs A2	md	10.4 kg	8.5 to 12.3		not stated; randomized; R0018231:Supplement Table S3
26	A2	change	-8.9 kg	-9.9 to -7.8	40	not stated; randomized; R0018231:Supplement Table S3

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	percent change	1.4 percent	0.0 to 2.8	20	not stated; randomized; R0018231:Supplement Table S3
26	A1 vs A2	md	10.0 percent	8.3 to 11.8		not stated; randomized; R0018231:Supplement Table S3
26	A2	percent change	-8.6 percent	-9.6 to -7.6	40	not stated; randomized; R0018231:Supplement Table S3

Weight loss of 10 percent or more (1 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A2	responders				18 / 40	not stated; randomized; R0018231:Results

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; randomized; registry:adverse_events
	A2	events				1 / 40	not stated; randomized; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; randomized; registry:adverse_events
	A2	events				0 / 40	not stated; randomized; registry:adverse_events

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	4 / 20	not stated; randomized; R0018231:Table 2
A1	events	5 / 20	not stated; randomized; registry:adverse_events
A2	events	9 / 40	not stated; randomized; R0018231:Table 2
A2	events	9 / 40	not stated; randomized; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; randomized; R0018231:Table 2
	A2	events				2 / 40	not stated; randomized; R0018231:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; randomized; registry:adverse_events
	A2	events				2 / 40	not stated; randomized; registry:adverse_events