parallel randomized trial

S003058

Design

Randomized: 48
Start year
Treatment: 12 weeks, follow-up 12 weeks
Countries: Japan (10 sites)
Sponsor: (non industry)
Eligibility: age 20 to 90; HbA1c 7.0 to 10.0 percent; on insulin glargine plus sitagliptin 50 mg at least 8 weeks

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug daily	insulin glargine titrated to fasting glucose about 110 mg/dL, other oral agents; lifestyle: not reported	23	18
A2	Vildagliptin Vildagliptin 50 mg twice daily	insulin glargine titrated to fasting glucose about 110 mg/dL, other oral agents; lifestyle: not reported	25	20

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

Characteristic	Statistic	Lixisenatide 20 ug subcutaneous once daily A1	Vildagliptin A2
age	mean (years)	61.3	64.7
age	sd (years)	9.3	2.6
bmi	mean (kg/m2)	26.4	24.6
bmi	sd (kg/m2)	3.7	6.5
diabetes duration	mean (years)	15.1	17.5
diabetes duration	sd (years)	8.5	9.5
egfr	mean (mL/min/1.73 m2)	70.4	68.6
egfr	sd (mL/min/1.73 m2)	14.2	19.4
female	n	9	7
hba1c	median (percent)	7.9	7.8
hba1c	q1 (percent)	7.2	7.3
hba1c	q3 (percent)	8.5	8.4
insulin dose	median (U)	13.5	10.0
insulin dose	q1 (U)	9.5	5.3
insulin dose	q3 (U)	22.5	15.5
metformin use	n	4	4
metformin use	percent	22	20
other agi use	n	6	9
other agi use	percent	33	45
other no oral agent	n	5	4
other no oral agent	percent	28	20
other sulfonylurea use	n	8	12
other sulfonylurea use	percent	44	60
other tzd use	n	1	1
other tzd use	percent	6	5
sbp	mean (mmHg)	134.9	128.8
sbp	sd (mmHg)	16.4	17.7
uacr	median (mg/gCr)	18.8	16.8
uacr	q1 (mg/gCr)	5.4	6.2
uacr	q3 (mg/gCr)	66.4	55.0
weight	mean (kg)	67.1	64.3
weight	sd (kg)	11.2	16.4

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.6 percent	0.7		18	not stated; completers; R0024376:Table 2
12	A2	change	-0.6 percent	1.2		20	not stated; completers; R0024376:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.55 kg	1.79		18	not stated; completers; R0024376:Table 2
12	A2	change	-0.08 kg	2.30		20	not stated; completers; R0024376:Table 2

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders				4 / 18	not stated; completers; R0024376:Results
12	A2	responders				7 / 20	not stated; completers; R0024376: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 / 18	not stated; completers; R0024376:Results
	A2	events				0 / 20	not stated; completers; R0024376:Results

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	mmHg			18	not stated; completers; R0024376:Table 2
12	A2	change	mmHg			20	not stated; completers; R0024376:Table 2

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	24.4 points	6.8		18	not stated; completers; R0024376:Table 4
12	A2	final	26.6 points	7.4		20	not stated; completers; R0024376:Table 4

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 18	not stated; completers; R0024376:Results
	A2	events				0 / 20	not stated; completers; R0024376:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 18	not stated; completers; R0024376:Results
	A2	events				0 / 20	not stated; completers; R0024376:Results

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; completers; R0024376:Results
	A2	events				1 / 20	not stated; completers; R0024376:Results