parallel randomized trial

NCT03068065

Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD)

Type 2 diabetes (adults)Metabolic dysfunction associated steatotic liver disease or steatohepatitis NCT03068065S000048

Design

Randomized: 93
Start year: 2014
Treatment: 24 weeks, follow-up 24 weeks
Countries: China (1 sites)
Sponsor: Nanjing Drum Tower Hospital (not reported)
Eligibility: age 18 to 70; drug naive 3 months; HbA1c 7 to 14 percent; BMI 20 to 38; NAFLD on ultrasound

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide	none; diet and exercise advice; lifestyle: standard	30	29	29
A2	Metformin Metformin	none; diet and exercise guidance; lifestyle: standard	31	29	29
A3	Gliclazide Gliclazide	none; diet and exercise guidance; lifestyle: standard	32	27	27

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	Metformin A2	Gliclazide A3
age	mean (years)	46.8	46.3	48.2
bmi	mean (kg/m2)	28.1	26.8	27.5
diabetes duration	max (months)	39	12	24
diabetes duration	min (months)	2	1	1
female	n	8	10	8
hba1c	mean (percent)	8.91	9.36	9.07
sbp	mean (mmHg)	120	127	122
waist	mean (cm)	95.6	92.6	95.6
weight	mean (kg)	81.1	74.8	78.13

Analyses this trial contributes to

Results

16 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
24	A1	final	5.90 percent	0.11	29	not stated; completers; R0025051:Table 2
24	A2	final	6.03 percent	0.09	29	not stated; completers; R0025051:Table 2
24	A3	final	6.47 percent	0.17	27	not stated; completers; R0025051:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	final	75.5 kg	2.0	29	not stated; completers; R0025051:Table 1
24	A2	final	71.2 kg	2.55	29	not stated; completers; R0025051:Table 1
24	A3	final	77.54 kg	2.57	27	not stated; completers; R0025051:Table 1

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	final	107 mmHg	2	29	not stated; completers; R0025051:Table 2
24	A2	final	112 mmHg	3	29	not stated; completers; R0025051:Table 2
24	A3	final	113 mmHg	3	27	not stated; completers; R0025051:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Detail
A1	events	not stated; other; R0025051:Results
A2	events	not stated; other; R0025051:Results
A3	events	not stated; other; R0025051:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 /	not stated; other; R0025051:Results
	A2	events				4 /	not stated; other; R0025051:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 /	not stated; other; R0025051:Results
	A2	events				10 /	not stated; other; R0025051:Results