parallel randomized trial

S003087

Design

Randomized: 65
Start year
Treatment: 2 weeks, follow-up 2 weeks
Countries: China (1 sites)
Sponsor: (not reported)
Eligibility: age over 20; T2D 1 year or more; HbA1c 8 to 14 percent; BMI 45 or less; metformin plus MDI

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability CSII plus liraglutide	CSII insulin aspart and metformin 2000 mg daily; lifestyle: standard	33	30
A2	Standard care or no added treatment CSII	CSII insulin aspart and metformin 2000 mg daily; lifestyle: standard	32	30

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

Characteristic	Statistic	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability A1	Standard care or no added treatment A2
age	median (years)	50.0	49.0
age	q1 (years)	42.5	42.5
age	q3 (years)	63.5	61.0
bmi	mean (kg/m2)	29.4	29.0
bmi	sd (kg/m2)	3.4	4.2
diabetes duration	median (years)	9.0	6.0
diabetes duration	q1 (years)	2.0	3.0
diabetes duration	q3 (years)	17.5	13.0
established cvd	n	9	6
female	n	3	7
hba1c	median (percent)	9.3	10.0
hba1c	q1 (percent)	8.5	8.8
hba1c	q3 (percent)	13.0	12.0
insulin dose	median (U/kg/day)	0.59	0.62
insulin dose	q1 (U/kg/day)	0.55	0.57
insulin dose	q3 (U/kg/day)	0.64	0.65
sbp	mean (mmHg)	140.0	135.3
sbp	sd (mmHg)	18.1	17.4
uacr: microalbuminuria	n	8	12
weight	mean (kg)	85.5	82.4
weight	sd (kg)	9.8	11.8

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

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
2	A1	change	-2.5 kg	0.5	30	not stated; completers; R0019704:Results
2	A2	change	0.2 kg	1.1	30	not stated; completers; R0019704:Results
2	A2 vs A1	md	2.7 kg			not stated; completers; R0019704: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 / 30	not stated; completers; R0019704:Results
	A2	events				0 / 30	not stated; completers; R0019704:Results

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	Events / N	Detail
2	A1	percent change	-2.93 percent	30	not stated; completers; R0019704:Results
2	A2	percent change	0.24 percent	30	not stated; completers; R0019704:Results
2	A2 vs A1	md	3.17 percent		not stated; completers; R0019704:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 30	not stated; completers; R0019704:Methods

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 30	not stated; completers; R0019704:Methods

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 30	not stated; completers; R0019704:Methods