parallel randomized trial

S003081

Design

Randomized: 40
Start year: 2015
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (1 sites)
Sponsor: (non industry)
Eligibility: age 20 or older; HbA1c below 7.5 percent on basal bolus insulin; BMI above 22

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Canagliflozin Canagliflozin plus basal insulin	basal insulin glargine or degludec titrated by algorithm; bolus insulin stopped; lifestyle: none	20	17
A2	liraglutide Liraglutide plus basal insulin	basal insulin glargine or degludec titrated to fasting SMBG; bolus insulin stopped; lifestyle: none	20	17

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

Characteristic	Statistic	Canagliflozin A1	Liraglutide plus basal insulin A2
age	mean (years)	55.9	58.2
age	sd (years)	13.0	11.5
bmi	mean (kg/m2)	27.0	26.8
bmi	sd (kg/m2)	3.3	3.1
diabetes duration	mean (years)	10.4	7.8
diabetes duration	sd (years)	6.9	7.0
egfr	mean (mL/min/1.73 m2)	74.1	74.8
egfr	sd (mL/min/1.73 m2)	15.7	23.7
hba1c	mean (percent)	6.8	6.4
hba1c	sd (percent)	0.7	0.6
insulin dose	mean (U/kg/day)	0.4	0.4
insulin dose	sd (U/kg/day)	0.2	0.2
metformin use	n	6	4
metformin use	percent	35.3	23.5
other agi use	n	1	0
other agi use	percent	5.9
other background: none	n	10	13
other background: none	percent	58.8	76.5
other glinide use	n	1	0
other glinide use	percent	5.9
other male	n	13	13
other male	percent	76.5	76.5
weight	mean (kg)	76.7	73.7
weight	sd (kg)	7.5	12.2

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	final	6.7 percent	0.7	17	not stated; full analysis; R0023867:Results
24	A1	change	-0.1 percent	0.6	17	not stated; full analysis; R0023867:Table 2
24	A2	change	-0.2 percent	0.6	17	not stated; full analysis; R0023867:Table 2
24	A2	final	6.2 percent	0.8	17	not stated; full analysis; R0023867:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.3 kg	3.3		17	not stated; full analysis; R0023867:Table 2
24	A2	change	-1.5 kg	2.9		17	not stated; full analysis; R0023867:Table 2

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 20	not stated; safety; R0023867:Table 4
A1	events	5 / 20	not stated; safety; R0023867:Table 4
A1	events	4 / 20	not stated; safety; R0023867:Table 4
A2	events	3 / 19	not stated; safety; R0023867:Table 4
A2	events	0 / 19	not stated; safety; R0023867:Table 4
A2	events	2 / 19	not stated; safety; R0023867:Table 4

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0023867:Table 4
	A2	events				0 / 19	not stated; safety; R0023867:Table 4

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	12.6 points	9.0		17	not stated; full analysis; R0023867:Table 2
24	A2	change	6.1 points	9.9		17	not stated; full analysis; R0023867:Table 2

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 20	not stated; randomized; gallstone surgery; R0023867:Figure 1
A1	events	1 / 20	not stated; randomized; hyperglycemia; R0023867:Figure 1
A1	events	1 / 20	not stated; randomized; hyperphagia; R0023867:Figure 1
A2	events	1 / 20	not stated; randomized; nausea; R0023867:Figure 1
A2	events	1 / 20	not stated; randomized; orthostatic hypotension; R0023867:Figure 1

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 20	not stated; randomized; nausea; R0023867:Figure 1

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; safety; R0023867:Results