parallel randomized trial

LAMP

Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study.

Type 2 diabetes (adults)Other conditions NCT03948347S001659

Design

Randomized: 636
Start year: 2019
Treatment: 12.86 weeks, follow-up 12.86 weeks
Countries: China (27 sites)
Sponsor: First Affiliated Hospital of Jinan University (non industry)
Eligibility: age 50 or older; type 2 diabetes known or new; minor ischemic stroke NIHSS 3 or less or TIA ABCD2 4 or more within 24 h

Conduct and analysis

Blinding: single blind
Sequence generation: not reported
Allocation concealment: pharmacy or sealed
Outcome adjudication: yes
Primary estimand: treatment policy
Analysis population: randomized
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Standard therapy	guideline stroke secondary prevention and glucose management; DPP-4 and SGLT2 inhibitors prohibited; lifestyle: not reported	319	319
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg plus standard therapy	guideline stroke secondary prevention and glucose management; DPP-4 and SGLT2 inhibitors prohibited; lifestyle: not reported	317	317

Baseline characteristics

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

Characteristic	Statistic	Standard care or no added treatment A1	Liraglutide 1.8 mg subcutaneous once daily A2
age	median (years)	64.0	63.0
age	q1 (years)	59.0	57.0
age	q3 (years)	70.0	70.0
bmi	median (kg/m2)	23.7	24.2
bmi	q1 (kg/m2)	22.0	22.5
bmi	q3 (kg/m2)	26.0	26.0
established cvd: coronary heart disease	n	27	30
established cvd: coronary heart disease	percent	8.5	9.5
established cvd: previous ischemic stroke	n	91	80
established cvd: previous ischemic stroke	percent	28.5	25.2
established cvd: previous tia	n	10	10
established cvd: previous tia	percent	3.1	3.2
female	n	115	116
female	percent	36.1	36.6
hba1c	median (percent)	8.2	8.1
hba1c	q1 (percent)	6.8	7.0
hba1c	q3 (percent)	10.0	9.8
sbp	median (mmHg)	154.0	152.0
sbp	q1 (mmHg)	140.0	139.0
sbp	q3 (mmHg)	166.0	167.0

Results

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

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			24 / 293	not stated; per protocol; R0005689:Supplement eTable 5
A1	events			25 / 319	treatment policy; randomized; R0005689:Table 2
A2	events			24 / 317	treatment policy; randomized; R0005689:Table 2
A2 vs A1	hr	0.93	0.53 to 1.62		treatment policy; randomized; R0005689:Table 2
A2	events			17 / 255	not stated; per protocol; R0005689:Supplement eTable 5
A2 vs A1	hr	0.77	0.42 to 1.44		not stated; per protocol; R0005689:Supplement eTable 5

All cause mortality (6 lines; O20)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			3 / 293	not stated; per protocol; R0005689:Supplement eTable 5
A1	events			4 / 319	treatment policy; randomized; R0005689:Table 2
A2 vs A1	hr	0.36	0.04 to 3.43		not stated; per protocol; R0005689:Supplement eTable 5
A2	events			1 / 255	not stated; per protocol; R0005689:Supplement eTable 5
A2	events			1 / 317	treatment policy; randomized; R0005689:Table 2
A2 vs A1	hr	0.24	0.03 to 2.10		treatment policy; randomized; R0005689:Table 2

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 293	not stated; per protocol; R0005689:Supplement eTable 5
A1	events	0 / 319	treatment policy; randomized; R0005689:Table 2
A2	events	0 / 255	not stated; per protocol; R0005689:Supplement eTable 5
A2	events	0 / 317	treatment policy; randomized; R0005689:Table 2