parallel randomized trial

LIGHT-ON

Efficacy of Liraglutide vs. Sitagliptin vs. Insulin Glargine Per Day on Liver Fat When Combined With Metformin in T2DM Subjects With Non-alcoholic Fatty-liver Disease

Type 2 diabetes (adults)Metabolic dysfunction associated steatotic liver disease or steatohepatitis NCT02147925S001525

Design

Randomized: 75
Start year: 2014
Treatment: 26 weeks, follow-up 26 weeks
Countries: China (10 sites)
Sponsor: Sun Yat-sen University (mixed)
Eligibility: age 30 to 75, HbA1c 6.5 to 10 percent on metformin, NAFLD with MRI-PDFF over 10 percent, BMI 20 to 35

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: participants without end of treatment evaluation classified as no improvement

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide plus metformin	metformin; lifestyle: standard	24	24
A2	Sitagliptin Sitagliptin plus metformin	metformin; lifestyle: standard	27	27
A3	Insulin glargine Insulin glargine plus metformin	metformin; lifestyle: standard	24	24

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	Sitagliptin A2	Insulin glargine A3
age	mean (years)	43.1	45.7	45.6
age	sd (years)	9.7	9.2	7.6
bmi	mean (kg/m2)	30.1	29.7	29.6
bmi	sd (kg/m2)	3.3	2.8	3.5
diabetes duration	mean (years)	3.3	4.3	5.8
diabetes duration	sd (years)	3.5	3.8	4.5
female	n	7	6	10
hba1c	mean (percent)	7.8	7.6	7.7
hba1c	sd (percent)	1.4	0.9	0.9
other mri pdff	mean (percent)	15.4	15.5	14.9
other mri pdff	sd (percent)	5.6	5.6	5.5
sbp	mean (mmHg)	125.2	124.9	126.9
sbp	sd (mmHg)	7.6	10.7	7.9
waist	mean (cm)	101.7	102.8	102.9
waist	sd (cm)	7.9	8.3	9.9
weight	mean (kg)	86.6	88.2	85.6
weight	sd (kg)	12.9	13.6	14.2

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-1.0 percent	0.9	24	not stated; randomized; R0024860:Table 2
26	A2	change	-1.0 percent	1.0	27	not stated; randomized; R0024860:Table 2
26	A3	change	-0.7 percent	1.3	24	not stated; randomized; R0024860:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-3.6 kg	4.9	24	not stated; randomized; R0024860:Table 2
26	A2	change	-1.7 kg	2.9	27	not stated; randomized; R0024860:Table 2
26	A3	change	-1.2 kg	4.2	24	not stated; randomized; R0024860:Table 2

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 24	not stated; safety; R0024860:Table 5
A2	events	1 / 27	not stated; safety; R0024860:Table 5
A3	events	2 / 24	not stated; safety; R0024860:Table 5

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-3.5 mmHg	8.6	24	not stated; randomized; R0024860:Table 2
26	A2	change	-1.6 mmHg	10.3	27	not stated; randomized; R0024860:Table 2
26	A3	change	0.6 mmHg	11.1	24	not stated; randomized; R0024860:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 24	not stated; randomized; R0024860:Results
A2	events	0 / 27	not stated; randomized; R0024860:Results
A3	events	0 / 24	not stated; randomized; R0024860:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 24	not stated; safety; nausea and vomiting; R0024860:Table 5
A2	events	0 / 27	not stated; safety; nausea and vomiting; R0024860:Table 5
A3	events	0 / 24	not stated; safety; nausea and vomiting; R0024860:Table 5