parallel randomized trial

S003062

Design

Randomized: 47
Start year: 2010
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (6 sites)
Sponsor: Keio University (mixed)
Eligibility: T2D age 20 to 75; BMI 23.5 or higher; HbA1c 6.9 to 9.4 percent; lifestyle with or without AGI or low dose metformin

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Metformin Metformin monotherapy	lifestyle: standard	24	24
A2	liraglutide Liraglutide monotherapy	lifestyle: standard	23	22

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

Characteristic	Statistic	Metformin A1	Liraglutide monotherapy A2
age	mean (years)	51	55
age	sd (years)	11	11
bmi	mean (kg/m2)	28.7	28.6
bmi	sd (kg/m2)	3.7	4.2
diabetes duration	mean (years)	4.7	5.6
diabetes duration	sd (years)	3.9	4.2
female	n	8	9
hba1c	mean (percent)	8.0	7.7
hba1c	sd (percent)	0.7	0.7
sbp	mean (mmHg)	136	132
sbp	sd (mmHg)	14	14
uacr: microalbuminuria	percent	8.3	9.1
waist	mean (cm)	97.3	96.3
waist	sd (cm)	10.3	9.4
weight	mean (kg)	78.9	76.2
weight	sd (kg)	16.5	11.6

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

HbA1c change (11 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.95 percent	0.80		24	not stated; completers; R0022917:Results
24	A1	final	7.0 percent	0.8		24	not stated; completers; R0022917:Results
24	A1	change	-1.28 percent	0.54			not stated; completers; background:no_prior_metformin; R0022917:Results
24	A1	change	-1.28 percent	0.54		12	not stated; completers; background:no_prior_oam; R0022917:Results
24	A1	change	-0.63 percent	0.90			not stated; completers; background:prior_metformin; R0022917:Results
24	A2 vs A1	md	0.30 percent		-0.09 to 0.69		not stated; completers; R0022917:Results
24	A2	change	-1.31 percent	0.38			not stated; completers; background:no_prior_metformin; R0022917:Results
24	A2	change	-1.38 percent	0.39		8	not stated; completers; background:no_prior_oam; R0022917:Results
24	A2	change	-0.38 percent	0.97			not stated; completers; background:prior_metformin; R0022917:Results
24	A2	change	-0.80 percent	0.88		22	not stated; completers; R0022917:Results
24	A2	final	6.9 percent	0.9		22	not stated; completers; R0022917:Results

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-0.9 kg	2.6	24	not stated; completers; R0022917:Results
24	A1	final	78.0 kg	17.7	24	not stated; completers; R0022917:Results
24	A2	change	-0.3 kg	1.9	22	not stated; completers; R0022917:Results
24	A2	final	75.9 kg	11.0	22	not stated; completers; R0022917:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	62.5			24	not stated; completers; R0022917:Results
24	A2	responders	59.1			22	not stated; completers; R0022917:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; completers; R0022917:Results
	A2	events				0 / 22	not stated; completers; R0022917:Results

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate	0.2			24	not stated; completers; R0022917:Results
	A2	rate	0.2			22	not stated; completers; R0022917:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; completers; R0022917:Discussion
	A2	events				0 / 22	not stated; completers; R0022917:Discussion

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; completers; R0022917:Discussion
	A2	events				0 / 22	not stated; completers; R0022917:Discussion

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; completers; R0022917:Discussion
	A2	events				0 / 22	not stated; completers; R0022917:Discussion

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; completers; pancreatitis; R0022917:p7
	A2	events				0 / 22	not stated; completers; pancreatitis; R0022917:p7

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; completers; R0022917:Discussion
	A2	events				0 / 22	not stated; completers; R0022917:Discussion