parallel randomized trial

STARDUST

Effects of the Glucagon Like-peptide 1 (GLP-1) Receptor Agonist Liraglutide on Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: a Randomized Controlled Trial

Type 2 diabetes (adults)Other conditions NCT04881110S000264

Design

Randomized: 60
Start year: 2021
Treatment: 24 weeks, follow-up 78.21 weeks
Countries: Italy (1 sites)
Sponsor: University of Campania Luigi Vanvitelli (non industry)
Eligibility: age 35 or older, T2D with PAD, foot TcPO2 30 to 49 mmHg, HbA1c 6.5 to 8 percent

Conduct and analysis

Blinding: single blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide group	tailored glucose lowering and cardiovascular risk factor therapy; lifestyle: not reported	30	27
A2	Standard care or no added treatment Control group (conventional care)	tailored glucose lowering and cardiovascular risk factor therapy; lifestyle: not reported	30	28

Baseline characteristics

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	Standard care or no added treatment A2
age	mean (years)	67.2	67.4
age	sd (years)	8.3	8.9
bmi	mean (kg/m2)	29.9	28.1
bmi	sd (kg/m2)	4.0	4.4
diabetes duration	mean (years)	15.2	16.5
diabetes duration	median (years)	11.0	10.0
diabetes duration	q1 (years)	5.5	3.0
diabetes duration	q3 (years)	25.0	30.0
diabetes duration	sd (years)	11.8	13.9
egfr	mean (mL/min/1.73 m2)	73.4	74.1
egfr	sd (mL/min/1.73 m2)	20.6	15.5
female	n	6	6
female	percent	22	21
hba1c	mean (percent)	7.1	6.8
hba1c	sd (percent)	0.5	0.8
insulin use	n	13	16
insulin use	percent	54	62
metformin use	n	18	20
metformin use	percent	75	77
sbp	median (mmHg)	130.0	140.0
sbp	q1 (mmHg)	130.0	130.0
sbp	q3 (mmHg)	140.0	140.0
uacr	median (mg/g)	47.4	60.0
uacr	q1 (mg/g)	24.1	39.0
uacr	q3 (mg/g)	117.5	74.3
waist	mean (cm)	110.6	106.1
waist	sd (cm)	8.6	10.0
weight	mean (kg)	80.9	81.9
weight	sd (kg)	14.3	13.5
white	n	27	28
white	percent	100	100

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.4 percent	1.0		27	not stated; completers; R0008968:Table 2
24	A1	final	6.7 percent	0.7		27	not stated; completers; R0008968:Supplement eTable 3
24	A1 vs A2	md	-0.4 percent		-0.8 to 0.01		not stated; completers; R0008968:Table 2
24	A2	change	-0.02 percent	0.4		28	not stated; completers; R0008968:Table 2
24	A2	final	6.8 percent	0.8		28	not stated; completers; R0008968:Supplement eTable 3
78.21	A1	final	6.6 percent	0.5		27	not stated; completers; R0017573:Table 2
78.21	A2	final	6.8 percent	0.7		28	not stated; completers; R0017573:Table 2

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.3 kg	3.2		27	not stated; completers; R0008968:Table 2
24	A1	final	78.5 kg	14.4		27	not stated; completers; R0008968:Supplement eTable 3
24	A1 vs A2	md	-1.1 kg		-3.6 to 1.2		not stated; completers; R0008968:Table 2
24	A2	change	-1.2 kg	5.0		28	not stated; completers; R0008968:Table 2
24	A2	final	80.7 kg	12.5		28	not stated; completers; R0008968:Supplement eTable 3
78.21	A1	final	78.1 kg	13.9		27	not stated; completers; R0017573:Table 2
78.21	A2	final	80.5 kg	12.8		28	not stated; completers; R0017573:Table 2

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-5.4 mmHg	8.3		27	not stated; completers; R0008968:Table 2
24	A1	final	mmHg			27	not stated; completers; R0008968:Supplement eTable 3
24	A1 vs A2	md	-0.03 mmHg		-5.8 to 5.8		not stated; completers; R0008968:Table 2
24	A2	change	-5.3 mmHg	11.8		28	not stated; completers; R0008968:Table 2
24	A2	final	mmHg			28	not stated; completers; R0008968:Supplement eTable 3
26.07	A1 vs A2	md	-0.003 mmHg		-5.8 to 5.8		not stated; completers; registry:outcomes
78.21	A1	final	mmHg			27	not stated; completers; R0017573:Table 2
78.21	A2	final	mmHg			28	not stated; completers; R0017573:Table 2

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Four point MACE including unstable angina (2 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; 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				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Gastroparesis (2 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events