parallel randomized trial

S003094

Design

Randomized
Start year: 2011
Treatment: 12 weeks, follow-up 12 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: HbA1c 7.5 to 11%; BMI 25 or more; waist 90 cm men, 85 cm women; insulin 10 U/day or more for 3 months

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide added	insulin reduced 0 to 30 percent plus oral agents; lifestyle: standard	42	42
A2	Insulin dose increase Insulin increasing	current insulin plus oral agents; lifestyle: standard	42	42

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

Characteristic	Statistic	Liraglutide 1.2 mg subcutaneous once daily A1	Insulin dose increase A2
age	mean (years)	51.2	52.7
age	sd (years)	10.5	10.8
bmi	mean (kg/m2)	30.4	30.3
bmi	sd (kg/m2)	3.2	3.0
diabetes duration	mean (years)	9.1	8.9
diabetes duration	sd (years)	3.6	3.6
female	n	16	18
hba1c	mean (percent)	8.79	8.69
hba1c	sd (percent)	0.86	0.91
insulin dose	mean (U/day)	41.2	41.6
insulin dose	sd (U/day)	17.4	16.5
metformin use	n	25	27
metformin use	percent	59.5	64.3
other agi use	n	15	13
other agi use	percent	35.7	31.0
other background: insulin glargine only	n	11	13
other background: insulin glargine only	percent	26.2	31.0
other background: insulin nph only	n	18	14
other background: insulin nph only	percent	42.9	33.3
other background: premixed insulin	n	13	15
other background: premixed insulin	percent	31.0	35.7
other glinide use	n	16	13
other glinide use	percent	38.1	31.0
other sulfonylurea use	n	7	9
other sulfonylurea use	percent	16.7	21.4
other tzd use	n	17	14
other tzd use	percent	40.5	33.3
waist	mean (cm)	105.6	104.6
waist	sd (cm)	12.6	10.5
weight	mean (kg)	88.6	86.3
weight	sd (kg)	11.8	10.3

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.9 percent		-2.10 to -1.72	42	not stated; completers; R0026794:Table 2
12	A1	final	6.88 percent	0.64		42	not stated; completers; R0026794:Table 2
12	A1 vs A2	md	-0.14 percent		-0.41 to 0.13		not stated; completers; R0026794:Table 2
12	A2	change	-1.77 percent		-2.00 to -1.56	42	not stated; completers; R0026794:Table 2
12	A2	final	6.93 percent	0.63		42	not stated; completers; R0026794:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-5.62 kg		-6.51 to -4.73	42	not stated; completers; R0026794:Table 2
12	A1	final	82.9 kg	11.2		42	not stated; completers; R0026794:Table 2
12	A1 vs A2	md	-7.6 kg		-8.67 to -6.57		not stated; completers; R0026794:Table 2
12	A2	change	2.00 kg		1.52 to 2.48	42	not stated; completers; R0026794:Table 2
12	A2	final	88.3 kg	10.4		42	not stated; completers; R0026794:Table 2

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

Arm	Statistic	Estimate	Events / N	Detail
A1	events	11.9	42	not stated; completers; R0026794:Results
A1	events		0 / 42	not stated; completers; R0026794:Results
A2	events	31.0	42	not stated; completers; R0026794:Results
A2	events		2 / 42	not stated; completers; R0026794:Results

Weight loss of 5 percent or more (1 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders				26 / 42	not stated; completers; R0026794:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0026794:Results
	A2	events				0 /	not stated; other; R0026794:Results