parallel randomized trial

S003102

Design

Randomized: 31
Start year: 2013
Treatment: 12 weeks, follow-up 12 weeks
Countries: Japan (5 sites)
Sponsor: (non industry)
Eligibility: age over 20; HbA1c 6.0 to below 9.0 percent on MDI over 3 months; total insulin 30 U/day or less; C-peptide 0.5 ng/mL or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Basal bolus insulin Continued MDI	oral agents continued; lifestyle: standard	15	15
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide plus insulin glargine	insulin glargine once daily replacing MDI, titrated to fasting glucose 110 mg/dL; oral agents continued; lifestyle: standard	16	11

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

Characteristic	Statistic	Basal bolus insulin A1	Lixisenatide 20 ug subcutaneous once daily A2
age	mean (years)	59.6	66.0
age	sd (years)	12.8	8.4
bmi	mean (kg/m2)	26.4	27.2
bmi	sd (kg/m2)	6.4	4.2
diabetes duration	mean (years)	21.4	18.6
diabetes duration	sd (years)	10.8	12.3
female	n	6	6
hba1c	mean (percent)	7.2	7.1
hba1c	sd (percent)	0.9	0.5
insulin dose	mean (U/kg/day)	0.38	0.32
insulin dose	sd (U/kg/day)	0.10	0.10
metformin use	n	3	5
other agi use	n	1	1
other glinide use	n	0	0
other sulfonylurea use	n	1	0
other tzd use	n	1	0
weight	mean (kg)	68.9	69.0
weight	sd (kg)	22.3	11.1

15 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	-0.05 percent	0.37		15	not stated; completers; R0026500:Table 3
12	A2	change	0.04 percent	0.38		11	not stated; completers; R0026500:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	0.6 kg	1.8		15	not stated; completers; R0026500:Table 3
12	A2	change	-2.5 kg	1.8		11	not stated; completers; R0026500:Table 3

Level 2 or 3 hypoglycemia (participants) (5 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	6.7	1 /	not stated; other; R0026500:Results
A1	events		0 /	not stated; other; R0026500:Results
A2	events		0 /	not stated; other; R0026500:Results
A2	events		0 /	not stated; other; R0026500:Results
A2	events	0	0 /	not stated; other; R0026500:Results

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	change	5.7 points	10.7		15	not stated; completers; R0026500:Table 2
12	A2	change	12.7 points	6.4		11	not stated; completers; R0026500:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; randomized; R0026500:Figure 1
	A2	events				2 / 16	not stated; randomized; nausea; R0026500:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; randomized; R0026500:Figure 1
	A2	events				2 / 16	not stated; randomized; nausea; R0026500:Results