parallel randomized trial

Lixilan-L-CN

A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)

Type 2 diabetes (adults)NCT03798080S002110

Design

Randomized: 426
Start year: 2019
Treatment: 30 weeks, follow-up 30.43 weeks
Countries: China (44 sites)
Sponsor: Sanofi (industry)
Eligibility: Chinese adults; HbA1c 7.0 to 10.5 percent; basal insulin 10 to 25 U/day with up to 2 oral drugs; FPG at most 8.9 mmol/L

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	IGlarLixi 2:1 pen subcutaneous once daily titrated iGlarLixi	metformin continued if used; lifestyle: not reported	212	210	203
A2	Insulin glargine Insulin glargine 100 U/mL	metformin continued if used; lifestyle: not reported	214	211	201

Baseline characteristics

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	Insulin glargine A2
age	mean (years)	58.2	56.7
age	sd (years)	8.7	9.3
bmi	mean (kg/m2)	25.2	25.3
bmi	sd (kg/m2)	2.7	3.0
diabetes duration	mean (years)	13.3	11.4
diabetes duration	sd (years)	6.2	6.0
egfr	mean (mL/min/1.73 m2)	90.8	91.8
egfr	sd (mL/min/1.73 m2)	22.0	18.0
hba1c	mean (percent)	8.3	8.3
hba1c	sd (percent)	0.9	0.9
insulin dose	mean (U/kg/day)	0.27	0.26
insulin dose	sd (U/kg/day)	0.07	0.07
metformin use	n	166	167
metformin use	percent	78.3	78.0
other male	n	126	122
other male	percent	59.4	57.0
weight	mean (kg)	69.3	69.8

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1 vs A2	md	-0.7 percent		-0.9 to -0.6		not stated; modified itt; R0014540:Table 2
30	A1	change	-1.4 percent	0.1		200	not stated; modified itt; R0014540:Table 2
30	A2	change	-0.7 percent	0.1		201	not stated; modified itt; R0014540:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	-0.3 kg	0.2		202	not stated; modified itt; R0014540:Table 2
30	A1 vs A2	md	-0.9 kg		-1.4 to -0.5		not stated; modified itt; R0014540:Table 2
30	A2	change	0.7 kg	0.2		201	not stated; modified itt; R0014540:Table 2

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
30	A1	responders			133 / 210	not stated; modified itt; R0014540:Table 2
30	A1 vs A2	rd	35.3	27.0 to 43.7		not stated; modified itt; R0014540:Table 2
30	A2	responders			63 / 211	not stated; modified itt; R0014540:Table 2

Level 2 or 3 hypoglycemia (participants) (8 lines; O04)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			141 / 211	not stated; safety; R0014540:Supplement Table S4
A1 vs A2	or	0.79	0.52 to 1.20		not stated; safety; R0014540:Supplement Table S4
A1	events			25 / 211	not stated; safety; R0014540:Supplement Table S4
A1	events			2 / 211	not stated; safety; R0014540:Supplement Table S4
A1 vs A2	or	1.05	0.58 to 1.91		not stated; safety; R0014540:Supplement Table S4
A2	events			152 / 212	not stated; safety; R0014540:Supplement Table S4
A2	events			24 / 212	not stated; safety; R0014540:Supplement Table S4
A2	events			2 / 212	not stated; safety; R0014540:Supplement Table S4

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	rate ratio	0.70		0.54 to 0.90		not stated; safety; R0014540:Supplement Table S4
	A1 vs A2	rate ratio	0.94		0.52 to 1.69		not stated; safety; R0014540:Supplement Table S4

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 211	not stated; safety; R0014540:Table 3
	A2	events				0 / 212	not stated; safety; R0014540:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 211	not stated; safety; R0014540:Table 3
	A2	events				15 / 212	not stated; safety; R0014540:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 211	not stated; safety; R0014540:Table 3
	A2	events				3 / 212	not stated; safety; R0014540:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 211	not stated; safety; R0014540:Table 3
	A2	events				3 / 212	not stated; safety; R0014540:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 211	not stated; safety; R0014540:Table 3
	A2	events				2 / 212	not stated; safety; R0014540:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 211	not stated; safety; R0014540:Table 3
	A2	events				10 / 212	not stated; safety; R0014540:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 211	not stated; safety; R0014540:Results
	A2	events				0 / 212	not stated; safety; R0014540:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 211	while on treatment; safety; pancreatitis; R0014540:Results
	A2	events				0 / 212	while on treatment; safety; pancreatitis; R0014540:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 211	not stated; safety; R0014540:Table 3
	A2	events				0 / 212	not stated; safety; R0014540:Table 3