parallel randomized trial

S002858

Design

Randomized: 101
Start year
Treatment: 24 weeks, follow-up 24 weeks
Countries: United Kingdom (1 sites)
Sponsor: (industry)
Eligibility: T2D age over 35; clinical CKD; eGFR above 30 mL/min; stable ACE inhibitor or ARB

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide	existing T2D and CKD therapy including RAS inhibition; lifestyle: not reported	51	47
A2	Placebo Placebo	existing diabetes and CKD therapy including RAS inhibition; lifestyle: not reported	50	43

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

Characteristic	Statistic	Lixisenatide 20 ug subcutaneous once daily A1	Placebo A2
age	mean (years)	61.0	62.8
age	sd (years)	8.3	10.3
asian	n	5	0
asian	percent	10.6	0
black	n	23	19
black	percent	48.9	44.2
egfr	mean (mL/min/1.73 m2)	62.5	71.9
egfr	sd (mL/min/1.73 m2)	23.0	29.2
female	n	19	13
female	percent	40.4	30.2
hba1c	mean (percent)	9.3	9.0
hba1c	sd (percent)	1.7	1.7
other race other	n	1	1
other race other	percent	2.1	2.3
sbp	mean (mmHg)	133.8	131.6
sbp	sd (mmHg)	19.8	14.9
waist	mean (cm)	118.3	119.7
waist	sd (cm)	12.7	13.1
weight	mean (kg)	101.1	103.0
weight	sd (kg)	19.2	20.6
white	n	18	23
white	percent	38.3	53.5

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	final	8.9 percent	8.6 to 9.3	47	not stated; modified itt; R0001573:Table 2
24	A1 vs A2	md	percent	-1.32 to -0.03		not stated; modified itt; R0001573:Table 2
24	A2	final	9.6 percent	9.1 to 9.9	43	not stated; modified itt; R0001573:Table 2

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	final	100.6 kg	98.6 to 102.5	47	not stated; modified itt; R0001573:Table 2
24	A1 vs A2	md	kg	-3.1 to 3.1		not stated; modified itt; R0001573:Table 2
24	A2	final	100.6 kg	98.5 to 102.6	43	not stated; modified itt; R0001573:Table 2

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	final	136.6 mmHg	132.3 to 140.9	47	not stated; modified itt; R0001573:Table 2
24	A1 vs A2	md	mmHg	-3.1 to 9.3		not stated; modified itt; R0001573:Table 2
24	A2	final	133.5 mmHg	128.9 to 137.9	43	not stated; modified itt; R0001573:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 51	not stated; randomized; R0001573:Supplement Table S2
	A2	events				0 / 50	not stated; randomized; R0001573:Supplement Table S2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 51	not stated; randomized; R0001573:Supplement Table S2
	A2	events				3 / 50	not stated; randomized; R0001573:Supplement Table S2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 51	not stated; randomized; R0001573:Supplement Table S1
	A2	events				2 / 50	not stated; randomized; R0001573:Supplement Table S1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 51	not stated; randomized; R0001573:Supplement Table S1
	A2	events				5 / 50	not stated; randomized; R0001573:Supplement Table S1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 51	not stated; randomized; R0001573:Supplement Table S1
	A2	events				2 / 50	not stated; randomized; R0001573:Supplement Table S1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 51	not stated; randomized; R0001573:Supplement Table S1
	A2	events				3 / 50	not stated; randomized; R0001573:Supplement Table S1

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 51	not stated; randomized; R0001573:Supplement Table S1
	A2	events				1 / 50	not stated; randomized; R0001573:Supplement Table S1

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 51	not stated; randomized; R0001573:Supplement Table S2
	A2	events				0 / 50	not stated; randomized; R0001573:Supplement Table S2