parallel randomized trial

S002992

Design

Randomized: 887
Start year
Treatment: 26 weeks, follow-up 26.43 weeks
Countries: multinational (89 sites)
Sponsor: Sanofi (industry)
Eligibility: adults 18 or older; HbA1c 7.5 to 10 percent; BMI 20 to less than 40; basal insulin 20 to 50 U plus metformin with or without SGLT2i

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	IGlarLixi 2:1 pen subcutaneous once daily titrated iGlarLixi	metformin with or without SGLT2 inhibitor; prior basal insulin stopped; lifestyle: not reported	443	443	428
A2	Premixed insulin BIAsp 30	metformin with or without SGLT2 inhibitor; prior basal insulin stopped; lifestyle: not reported	444	444	416

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

Characteristic	Statistic	IGlarLixi 2:1 pen subcutaneous once daily titrated A1	Premixed insulin A2	Whole trial ALL
age	mean (years)	59.8	59.8
age	sd (years)	10.3	10.0
bmi	mean (kg/m2)	29.7	30.0
bmi	sd (kg/m2)	4.7	5.1
diabetes duration	mean (years)	13.0	13.0
diabetes duration	sd (years)	7.1	7.4
established cvd: heart failure	n	11	8
established cvd: heart failure	percent	2.5	1.8
established cvd: ischemic stroke	n	2	0
established cvd: ischemic stroke	percent	0.5
established cvd: peripheral artery disease	n	2	9
established cvd: peripheral artery disease	percent	0.5	2.0
female	n	219	226
female	percent	49.4	50.9
hba1c	mean (percent)	8.6	8.6
hba1c	sd (percent)	0.7	0.7
insulin dose	mean (U/kg/day)	0.43	0.43
insulin dose	sd (U/kg/day)	0.15	0.14
metformin use	n	443	442
metformin use	percent	100.0	99.5
sglt2i use	n	104	102
sglt2i use	percent	23.5	23.0
weight	mean (kg)	80.7	82.2
weight	sd (kg)	16.5	18.5
white	percent			62.4

36 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
26	A1	final	7.3 percent	1.1			not stated; randomized; R0010673:Results
26	A1 vs A2	md	-0.2 percent		-0.4 to -0.1		not stated; randomized; R0010673:Results
26	A1	change	-1.3 percent			443	not stated; randomized; R0010673:Abstract
26	A2	change	-1.1 percent			444	not stated; randomized; R0010673:Abstract
26	A2	final	7.5 percent	1.0			not stated; randomized; R0010673:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Detail
26	A1	final	80.2 kg	16.6		not stated; randomized; R0010673:Results
26	A1 vs A2	md	-1.9 kg		-2.3 to -1.4	not stated; randomized; R0010673:Results
26	A2	final	83.4 kg	19.0		not stated; randomized; R0010673:Results

Level 2 or 3 hypoglycemia (participants) (7 lines; O04)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1 vs A2	or	0.62	0.47 to 0.81		not stated; safety; R0010673:Results
A1 vs A2	or	0.45	0.28 to 0.73		not stated; safety; R0019745:Figure 1
A1	events			114 / 442	not stated; safety; R0019745:Figure 1
A1 vs A2	or	0.55	0.42 to 0.74		not stated; safety; R0019745:Figure 1
A1	events			28 / 442	not stated; safety; R0019745:Figure 1
A2	events			57 / 441	not stated; safety; R0019745:Figure 1
A2	events			170 / 441	not stated; safety; R0019745:Figure 1

Level 2 or 3 hypoglycemia (episode rate) (8 lines; O04B)

Arm	Statistic	Estimate	95% CI	Detail
A1	rate			not stated; safety; R0019745:Results
A1	rate	0.25		not stated; safety; R0019745:Figure 1
A1 vs A2	rate ratio	0.40	0.23 to 0.71	not stated; safety; R0019745:Figure 1
A1	rate	2.03		not stated; safety; R0019745:Figure 1
A1 vs A2	rate ratio	0.71	0.52 to 0.99	not stated; safety; R0019745:Figure 1
A2	rate	0.56		not stated; safety; R0019745:Figure 1
A2	rate			not stated; safety; R0019745:Results
A2	rate	2.83		not stated; safety; R0019745:Figure 1

All cause mortality (1 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 442	not stated; safety; R0010673:Results

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 441	not stated; safety; cardiac failure/pulmonary edema; R0010673:Results

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	11.10 points	9.87 to 12.34	429	not stated; randomized; R0019324:Results
26	A1 vs A2	md	5.08 points	3.69 to 6.47		not stated; randomized; R0019324:Results
26	A2	change	6.02 points	4.81 to 7.23	420	not stated; randomized; R0019324:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	2.7			442	not stated; safety; R0010673:Results
	A2	events	2.9			441	not stated; safety; R0010673:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	0.9			442	not stated; safety; R0010673:Results
	A2	events	0.9			441	not stated; safety; R0010673:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	7.7			442	not stated; safety; R0010673:Results
	A2	events	0			441	not stated; safety; R0010673:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 442	not stated; safety; R0010673:Results
	A2	events				0 / 441	not stated; safety; R0010673:Results