parallel randomized trial

S003072

Design

Randomized: 122
Start year: 2011
Treatment: 12 weeks, follow-up 12 weeks
Countries: Japan
Sponsor: (mixed)
Eligibility: age 20 to 80; HbA1c above 6.9 percent on sitagliptin 50 mg for 3 months or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Vildagliptin Vildagliptin	prestudy oral drugs other than sitagliptin, if any; lifestyle: not reported	62	58
A2	Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg	prestudy oral drugs other than sitagliptin, if any; lifestyle: not reported	60	54

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

Characteristic	Statistic	Vildagliptin A1	Liraglutide 0.9 mg injection once daily A2	Whole trial ALL
age	mean (years)			64.7
age	sd (years)			12.4
bmi	mean (kg/m2)			24.7
bmi	sd (kg/m2)			5.2
female	n	22	19
hba1c	mean (percent)			8.0
hba1c	sd (percent)			1.5
metformin use	n	30	29
other sulfonylurea use	n	25	25
other tzd use	n	2	1
sbp	mean (mmHg)	130.3	133.3
sbp	sd (mmHg)	24.7	19.1
waist	mean (cm)	90.0	91.1
waist	sd (cm)	10.7	11.6
weight	mean (kg)	63.2	65.8
weight	sd (kg)	14.1	16.1

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	final	7.5 percent	1.3		not stated; other; R0023470:Supplement Table S1
12	A1	final	7.8 percent	1.1	58	not stated; completers; R0023470:Table 1
12	A1	change	-0.36 percent	0.53	58	not stated; completers; R0023470:Results
12	A2	change	-0.67 percent	0.12	54	not stated; completers; R0023470:Results
12	A2	final	7.3 percent	1.0	54	not stated; completers; R0023470:Table 1
12	A2	final	7.0 percent	1.0		not stated; other; R0023470:Supplement Table S1

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	final	63.3 kg	13.9	58	not stated; completers; R0023470:Table 1
12	A1	final	63.0 kg	13.9		not stated; other; R0023470:Supplement Table S1
12	A2	final	64.2 kg	16.2	54	not stated; completers; R0023470:Table 1
12	A2	final	64.3 kg	16.0		not stated; other; R0023470:Supplement Table S1

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 58	while on treatment; completers; R0023470:Results
A1	events	0 / 58	while on treatment; completers; R0023470:Results
A1	events	0 / 58	while on treatment; completers; R0023470:Results
A2	events	0 / 54	while on treatment; completers; R0023470:Results
A2	events	0 / 54	while on treatment; completers; R0023470:Results
A2	events	0 / 54	while on treatment; completers; R0023470:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	final	122.4 mmHg	29.1	58	not stated; completers; R0023470:Table 1
12	A1	final	126.7 mmHg	19.3		not stated; other; R0023470:Supplement Table S1
12	A2	final	130.8 mmHg	26.5	54	not stated; completers; R0023470:Table 1
12	A2	final	132.9 mmHg	19.8		not stated; other; R0023470:Supplement Table S1

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	final	25.8 points	5.6		58	not stated; completers; R0023470:Table 3
12	A2	final	24.4 points	7.3		54	not stated; completers; R0023470:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 58	while on treatment; completers; R0023470:Table 4
	A2	events				1 / 54	while on treatment; completers; R0023470:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 58	while on treatment; completers; R0023470:Table 4
	A2	events				1 / 54	while on treatment; completers; R0023470:Table 4

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 58	while on treatment; completers; R0023470:Table 4
	A2	events				1 / 54	while on treatment; completers; R0023470:Table 4

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 58	while on treatment; completers; R0023470:Results
	A2	events				0 / 54	while on treatment; completers; R0023470:Results