parallel randomized trial

NCT02765399

The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis - a Single-center Randomized Controlled Study

Type 2 diabetes (adults)NCT02765399S000370

Design

Randomized: 23
Start year: 2015
Treatment: 16 weeks, follow-up 16 weeks
Countries: Finland (1 sites)
Sponsor: Helsinki University Central Hospital (mixed)
Eligibility: age 30 to 75; BMI 27 to 40; HbA1c 6 to 9 percent; lifestyle or metformin

Conduct and analysis

Blinding: single blind
Sequence generation: not reported
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 1.8 mg	metformin and statin; lifestyle: intensive	16	15
A2	Placebo Placebo	metformin and statin; lifestyle: intensive	7	7

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)	62	63
age	sd (years)	2	2
asian	n	0	0
bmi	mean (kg/m2)	31.8	33.0
bmi	sd (kg/m2)	3.4	4.1
diabetes duration	mean (years)	7.8	5.9
diabetes duration	sd (years)	4.7	6.5
female	n	2	4
hba1c	mean (percent)	7.0	6.3
hba1c	sd (percent)	1.0	0.3
sbp	mean (mmHg)	135	145
sbp	sd (mmHg)	14	10
waist	mean (cm)	114.4	115.0
waist	sd (cm)	6.7	5.5
weight	mean (kg)	98.6	92.0
weight	sd (kg)	11.0	7.4
white	n	16	7

Analyses this trial contributes to

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-0.6 percent	0.7		15	not stated; completers; R0022111:Table 1
16	A2	change	0.1 percent	0.3		7	not stated; completers; R0022111:Table 1

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-2.4 kg	2.5		15	not stated; completers; R0022111:Table 1
16	A2	change	-2.1 kg	3.0		7	not stated; completers; R0022111:Table 1

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	4 mmHg	13		15	not stated; completers; R0022111:Table 1
16	A2	change	-8 mmHg	6		7	not stated; completers; R0022111:Table 1

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	percent change	-2.5 percent			15	not stated; completers; R0022111:Table 1
16	A2	percent change	-2.2 percent			7	not stated; completers; R0022111:Table 1

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; safety; registry:adverse_events
	A2	events				0 / 7	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; safety; registry:adverse_events
	A2	events				0 / 7	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 16	not stated; randomized; registry:flow
	A2	events				0 / 7	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 16	not stated; safety; registry:adverse_events
	A2	events				1 / 7	not stated; safety; registry:adverse_events

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 16	not stated; randomized; registry:flow
	A2	events				0 / 7	not stated; randomized; registry:flow