parallel randomized trial

D-LIFT

Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Design

Randomized: 64
Start year: 2018
Treatment: 24 weeks
Countries: India (1 sites)
Sponsor: Medanta, The Medicity, India (non industry)
Eligibility: age over 20; type 2 diabetes HbA1c 7.0 to 10.0; MRI-PDFF liver fat 6 percent or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Usual care	metformin with or without DPP-4 inhibitor, sulfonylurea or insulin, adjusted to target; lifestyle: standard	32	25
A2	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide plus usual care	metformin with or without sulfonylurea or insulin, adjusted to target; lifestyle: standard	32	27

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

Characteristic	Statistic	Standard care or no added treatment A1	Dulaglutide 1.5 mg subcutaneous once weekly A2	Whole trial ALL
age	mean (years)	48.1	46.6
age	sd (years)	8.9	9.1
asian	percent			100
bmi	mean (kg/m2)	29.9	29.6
bmi	sd (kg/m2)	3.9	3.6
diabetes duration	mean (years)	5.7	4.9
diabetes duration	sd (years)	4.3	3.1
established cvd	n	1	0
established cvd	percent	3.1	0
female	percent			30
hba1c	mean (percent)	8.4	8.4
hba1c	sd (percent)	1.0	1.0
insulin use	n	1	0
insulin use	percent	3.1	0
metformin use	n	32	32
metformin use	percent	100	100
other dpp4 use	n	14	13
other dpp4 use	percent	43.8	40.6
other male	n	22	23
other male	percent	69	72
other sulfonylurea use	n	13	10
other sulfonylurea use	percent	40.6	31.3
sbp	mean (mmHg)	127	126
sbp	sd (mmHg)	17	15
weight	mean (kg)	83.7	85.8
weight	sd (kg)	13.0	13.3

12 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	95% CI	Events / N	Detail
24	A1	change	-1.3 percent	0.2		25	not stated; per protocol; R0016566:Table 3
24	A2	change	-1.6 percent	0.2		27	not stated; per protocol; R0016566:Table 3
24	A2 vs A1	md	-0.3 percent		-0.9 to 0.2		not stated; per protocol; R0016566:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.0 kg	0.7		25	not stated; per protocol; R0016566:Table 3
24	A2	change	-4.3 kg	0.5		27	not stated; per protocol; R0016566:Table 3
24	A2 vs A1	md	-2.3 kg		-4.1 to -0.6		not stated; per protocol; R0016566:Table 3

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	24.0			25	not stated; per protocol; R0016566:Results
24	A2	responders	55.6			27	not stated; per protocol; R0016566:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; randomized; R0016566:Figure 1
	A2	events				3 / 32	not stated; randomized; R0016566:Figure 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; randomized; R0016566:Figure 1
	A2	events				3 / 32	not stated; randomized; R0016566:Figure 1