parallel randomized trial

NCT02505334

A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus

Design

Randomized: 466
Start year: 2015
Treatment: 26 weeks, follow-up 27 weeks
Countries: Japan (45 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: Japanese adults on one oral drug, HbA1c 7.5 to 10.0 percent; randomized if HbA1c 7.0 or more after run in

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	lifestyle: not reported	233	233	218
A2	Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg	lifestyle: not reported	233	233	194

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	Liraglutide 0.9 mg injection once daily A2
age	mean (years)	55.07	54.96
age	sd (years)	10.27	10.61
asian	n	233	233
bmi	mean (kg/m2)	27.34	27.20
bmi	sd (kg/m2)	4.80	4.72
diabetes duration	mean (years)	9.40	9.15
diabetes duration	sd (years)	5.70	5.40
female	n	77	68
female	percent	33.0	29.2
hba1c	mean (percent)	8.14	8.10
hba1c	sd (percent)	1.02	0.87
sbp	mean (mmHg)	128.0	128.8
sbp	sd (mmHg)	13.1	13.1
waist	mean (cm)	93.68	93.82
waist	sd (cm)	11.75	11.50
weight	mean (kg)	74.67	75.13
weight	sd (kg)	15.24	16.46

36 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
26	A1 vs A2	md	-0.40 percent		-0.55 to -0.24		not stated; full analysis; R0022075:Results
26	A1	change	-0.23 percent	0.06		233	not stated; full analysis; registry:outcomes
26	A2	change	0.17 percent	0.06		233	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.77 kg	2.01		233	not stated; full analysis; R0022075:Results
26	A2	change	-0.95 kg	2.19		233	not stated; full analysis; R0022075:Results

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	22.7		233	not stated; full analysis; R0022075:Results
26	A1	responders			53 / 233	not stated; full analysis; registry:outcomes
26	A1 vs A2	or	3.87	2.12 to 7.08		not stated; full analysis; R0022075:Results
26	A2	responders			18 / 233	not stated; full analysis; registry:outcomes
26	A2	responders	7.7		233	not stated; full analysis; R0022075:Results

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 233	not stated; safety; R0022075:Table 2
A1	events	0 / 233	not stated; safety; R0022075:Table 2
A2	events	0 / 233	not stated; safety; R0022075:Table 2
A2	events	0 / 233	not stated; safety; R0022075:Table 2

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.7 mmHg	12.8		233	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-2.5 mmHg		-4.5 to -0.6		not stated; full analysis; R0022075:Results
26	A2	change	0.4 mmHg	12.2		233	not stated; full analysis; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 233	not stated; safety; R0022075:Supplement Table S2
	A2	events				0 / 233	not stated; safety; R0022075:Supplement Table S2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 233	not stated; safety; R0022075:Table 2
	A2	events				3 / 233	not stated; safety; R0022075:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 233	not stated; safety; R0022075:Table 2
A1	events	3 / 233	not stated; randomized; registry:flow
A2	events	2 / 233	not stated; safety; R0022075:Table 2
A2	events	3 / 233	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	3.4			233	not stated; safety; R0022075:Results
	A2	events	2.1			233	not stated; safety; R0022075:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	3.9			233	not stated; safety; R0022075:Results
	A2	events	2.6			233	not stated; safety; R0022075:Results

Constipation (3 lines; O27D)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	5.6	233	not stated; safety; R0022075:Results
A2	events	2.1	233	not stated; safety; R0022075:Results
A2	events		5 / 233	not stated; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 233	not stated; safety; R0022075:Supplement Table S2
	A2	events				1 / 233	not stated; safety; R0022075:Supplement Table S2

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 233	not stated; safety; R0022075:Supplement Table S2
	A2	events				0 / 233	not stated; safety; R0022075:Supplement Table S2