parallel randomized trial

NCT03101930

Cardiovascular Effects of GLP-1 Receptor Activation

Design

Randomized: 93
Start year: 2017
Treatment: 14 weeks, follow-up 14 weeks
Countries: United States (1 sites)
Sponsor: Vanderbilt University Medical Center (mixed)
Eligibility: age 18 to 65; BMI >=30 kg/m2; prediabetes by ADA criteria; no diabetes

Arm	Treatment	Background	Randomized	Analyzed
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide	lifestyle: none	46	44
A2	Sitagliptin Sitagliptin	lifestyle: none	23	22
A3	Lifestyle intervention (randomized arm) Hypocaloric diet	lifestyle: intensive	24	22

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

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Sitagliptin A2	Lifestyle intervention (randomized arm) A3
age	mean (years)	49.8	52.4	49.2
age	sd (years)	10.1	10.5	12.5
asian	n	2	0	0
asian	percent	4.5	0	0
black	n	4	3	4
black	percent	9.1	13.6	18.2
bmi	mean (kg/m2)	38.8	39.9	38.4
bmi	sd (kg/m2)	6.1	6.0	5.9
female	n	31	15	14
female	percent	70.5	68.2	63.6
hba1c	mean (percent)	5.7	5.8	5.7
hba1c	sd (percent)	0.3	0.3	0.3
hispanic	n	1	2	1
hispanic	percent	2.3	9.1	4.5
other race multiple	n	0	1	1
other race multiple	percent	0	4.5	4.5
sbp	mean (mmHg)	124.1	120.2	127.7
sbp	sd (mmHg)	7.7	11.3	8.3
waist	mean (cm)	115.8	118.4	117.5
waist	sd (cm)	11.5	14.5	13.6
weight	mean (kg)	108.8	111.4	111.3
weight	sd (kg)	20.9	22.0	21.5
white	n	38	18	17
white	percent	86.4	81.8	77.3

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

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
14	A1	final	122.2 mmHg	7.8		44	not stated; other; R0008795:Table 2
14	A2	final	118.2 mmHg	13.9		22	not stated; other; R0008795:Table 2
14	A3	change	-8.0 mmHg		-11.6 to -4.3		not stated; other; R0008795:Results
14	A3	final	119.7 mmHg	11.1		22	not stated; other; R0008795:Table 2

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 46	not stated; safety; registry:adverse_events
A2	events	0 / 23	not stated; safety; registry:adverse_events
A3	events	0 / 24	not stated; safety; registry:adverse_events

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 46	not stated; safety; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 46	not stated; safety; registry:adverse_events
A2	events	1 / 23	not stated; safety; registry:adverse_events
A3	events	1 / 24	not stated; safety; registry:adverse_events

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	8 / 46	not stated; safety; registry:adverse_events
A2	events	0 / 23	not stated; safety; registry:adverse_events
A3	events	1 / 24	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 46	not stated; safety; registry:adverse_events
A2	events	0 / 23	not stated; safety; registry:adverse_events
A3	events	0 / 24	not stated; safety; registry:adverse_events

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 46	not stated; safety; registry:adverse_events
A2	events	0 / 23	not stated; safety; registry:adverse_events
A3	events	0 / 24	not stated; safety; registry:adverse_events