parallel randomized trial

LIRAFLAME

Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes: A Randomized, Placebo-controlled, Double-blind, Parallel Clinical PET/CT Trial The Liraflame Trial

Type 2 diabetes (adults)NCT03449654S001895

Design

Randomized: 102
Start year: 2017
Treatment: 26 weeks, follow-up 26 weeks
Countries: Denmark (1 sites)
Sponsor: Steno Diabetes Center Copenhagen (mixed)
Eligibility: T2D; age above 50; HbA1c 48 mmol/mol or more; eGFR 30 or more

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: complete case, no imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide	stable glucose and lipid lowering therapy; lifestyle: not reported	51	50
A2	Placebo Placebo	stable glucose and lipid lowering therapy; lifestyle: not reported	51	49

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	Placebo A2
age	mean (years)	65.9	66.9
age	sd (years)	8.6	7.8
bmi	mean (kg/m2)	30.5	29.3
bmi	sd (kg/m2)	5.3	3.8
diabetes duration	median (years)	12.2	10.2
diabetes duration	q1 (years)	5.4	5.7
diabetes duration	q3 (years)	18.2	19.2
egfr	mean (mL/min/1.73 m2)	82.7	83.7
egfr	sd (mL/min/1.73 m2)	17.6	15.0
established cvd	n	14	9
established cvd	percent	27.5	17.7
female	n	6	10
female	percent	11.8	19.6
hba1c	mean (mmol/mol)	58.7	58.0
hba1c	sd (mmol/mol)	9.6	10.6
insulin use	n	20	19
insulin use	percent	39.2	37.3
sbp	mean (mmHg)	133	137
sbp	sd (mmHg)	15	20
sglt2i use	n	8	12
sglt2i use	percent	15.7	23.5
uacr	median (mg/g)	6.0	6.0
uacr	q1 (mg/g)	3.5	3.5
uacr	q3 (mg/g)	15	14.5

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1	change	-0.47 percent	-0.74 to -0.18	not stated; modified itt; R0010519:Results
26	A1 vs A2	md	-0.46 percent	-0.78 to -0.14	not stated; modified itt; R0010519:Results
26	A2	change	-0.01 percent	-0.17 to 0.16	not stated; modified itt; R0010519:Results

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

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1	change	-3.7 kg	-4.8 to -2.6	not stated; modified itt; R0010519:Results
26	A1 vs A2	md	-3.5 kg	-4.8 to -2.3	not stated; modified itt; R0010519:Results
26	A2	change	-0.2 kg	-0.8 to 0.4	not stated; modified itt; R0010519:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0010519:Results
	A2	events				0 /	not stated; other; R0010519:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 51	not stated; other; R0010519:Results
	A2	events				1 / 51	not stated; other; R0010519:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 51	not stated; other; R0010519:Results
	A2	events				0 / 51	not stated; other; R0010519:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0010519:Results
	A2	events				0 /	not stated; other; R0010519:Results