parallel randomized trial

LIXILAN JP-O1

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

Type 2 diabetes (adults)NCT02749890S002018

Design

Randomized: 321
Start year: 2016
Treatment: 52 weeks, follow-up 52.43 weeks
Countries: Japan (61 sites)
Sponsor: Sanofi (industry)
Eligibility: insulin naive Japanese adults; HbA1c 7.5 to 10%; FPG 13.8 mmol/L or less; one or two OADs

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	IGlarLixi 2:1 pen subcutaneous once daily titrated iGlarLixi	one or two OADs continued; DPP-4 inhibitors stopped; lifestyle: not reported	161	161
A2	Lixisenatide 20 ug subcutaneous once daily Lixi	one or two OADs continued; DPP-4 inhibitors stopped; lifestyle: not reported	160	160

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	Lixisenatide 20 ug subcutaneous once daily A2
age	mean (years)	58.3	57.7
age	sd (years)	9.9	11.5
bmi: 30 or more	n	32	32
bmi: 30 or more	percent	19.9	20.0
bmi	mean (kg/m2)	26.79	26.85
bmi	sd (kg/m2)	4.44	4.17
diabetes duration	mean (years)	8.12	9.22
diabetes duration	sd (years)	6.04	6.39
female	n	57	58
female	percent	35.4	36.3
hba1c	mean (percent)	8.39	8.38
hba1c	sd (percent)	0.64	0.63
metformin use	n	88	83
metformin use	percent	54.7	51.9
other sulfonylurea use	n	50	52
other sulfonylurea use	percent	31.1	32.5
weight	mean (kg)	72.26	72.99
weight	sd (kg)	14.80	14.88

Analyses this trial contributes to

Results

76 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	6.73 percent	0.75		161	hypothetical; modified itt; R0015751:Table 2
26	A1	change	-1.58 percent	0.072		161	hypothetical; modified itt; R0015751:Table 2
26	A1 vs A2	md	-1.07 percent	0.092	-1.251 to -0.889		hypothetical; modified itt; R0015751:Table 2
26	A2	change	-0.51 percent	0.073		160	hypothetical; modified itt; R0015751:Table 2
26	A2	final	7.79 percent	1.00		160	hypothetical; modified itt; R0015751:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	0.62 kg	0.177		161	hypothetical; modified itt; R0015751:Table 2
26	A1	final	72.91 kg	15.02		161	hypothetical; modified itt; R0015751:Table 2
26	A1 vs A2	md	1.94 kg	0.236	1.479 to 2.407		hypothetical; modified itt; R0015751:Table 2
26	A2	change	-1.32 kg	0.180		157	hypothetical; modified itt; R0015751:Table 2
26	A2	final	71.70 kg	15.06		157	hypothetical; modified itt; R0015751:Table 2

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders			105 / 161	hypothetical; modified itt; R0015751:Table 2
26	A1 vs A2	rd	45.90	36.71 to 55.09		hypothetical; modified itt; R0015751:Table 2
26	A2	responders			31 / 160	hypothetical; modified itt; R0015751:Table 2
52	A1	responders	61.5		161	not stated; modified itt; R0015751:Conclusions
52	A2	responders	15.6		160	not stated; modified itt; R0015751:Conclusions

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

Arm	Statistic	Events / N	Detail
A1	events	21 / 161	while on treatment; safety; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; R0015751:Table 3
A1	events	29 / 161	while on treatment; safety; R0015751:Table 3
A2	events	0 / 160	while on treatment; safety; R0015751:Table 3
A2	events	4 / 160	while on treatment; safety; R0015751:Table 3
A2	events	7 / 160	while on treatment; safety; R0015751:Table 3
A2	events	0 / 160	while on treatment; safety; R0015751:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate	0.80				while on treatment; safety; R0015751:Table 3
	A2	rate	0.10				while on treatment; safety; R0015751:Table 3

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 161	while on treatment; safety; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; R0015751:Table 3

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 160	while on treatment; safety; congestive heart failure; R0015751:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 161	while on treatment; safety; R0015751:Table 3
A1	events	7 / 161	while on treatment; safety; R0015751:Table 3
A2	events	13 / 160	while on treatment; safety; R0015751:Table 3
A2	events	4 / 160	while on treatment; safety; R0015751:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 161	while on treatment; safety; R0015751:Table 3
A1	events	4 / 161	while on treatment; safety; R0015751:Table 3
A2	events	17 / 160	while on treatment; safety; R0015751:Table 3
A2	events	20 / 160	while on treatment; safety; R0015751:Table 3

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	23 / 161	while on treatment; safety; R0015751:Table 3
A1	events	24 / 161	while on treatment; safety; R0015751:Table 3
A2	events	45 / 160	while on treatment; safety; R0015751:Table 3
A2	events	43 / 160	while on treatment; safety; R0015751:Table 3

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	10 / 161	while on treatment; safety; R0015751:Table 3
A1	events	9 / 161	while on treatment; safety; R0015751:Table 3
A2	events	8 / 160	while on treatment; safety; R0015751:Table 3
A2	events	8 / 160	while on treatment; safety; R0015751:Table 3

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	13 / 161	while on treatment; safety; R0015751:Table 3
A1	events	8 / 161	while on treatment; safety; R0015751:Table 3
A2	events	10 / 160	while on treatment; safety; R0015751:Table 3
A2	events	11 / 160	while on treatment; safety; R0015751:Table 3

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	2 / 161	while on treatment; safety; R0015751:Table 3
A1	events	4 / 161	while on treatment; safety; R0015751:Table 3
A2	events	9 / 160	while on treatment; safety; R0015751:Table 3
A2	events	10 / 160	while on treatment; safety; R0015751:Table 3

Discontinuation due to gastrointestinal adverse events (20 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 161	while on treatment; safety; vomiting; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; constipation; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; diarrhea; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; dyspepsia; R0015751:Table 3
A1	events	2 / 161	while on treatment; safety; nausea; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; constipation; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; diarrhea; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; dyspepsia; R0015751:Table 3
A1	events	2 / 161	while on treatment; safety; nausea; R0015751:Table 3
A1	events	0 / 161	while on treatment; safety; vomiting; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; vomiting; R0015751:Table 3
A2	events	8 / 160	while on treatment; safety; nausea; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; vomiting; R0015751:Table 3
A2	events	8 / 160	while on treatment; safety; nausea; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; dyspepsia; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; constipation; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; diarrhea; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; constipation; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; diarrhea; R0015751:Table 3
A2	events	1 / 160	while on treatment; safety; dyspepsia; R0015751:Table 3

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 161	while on treatment; safety; R0015751:Table 3
	A2	events				0 / 160	while on treatment; safety; R0015751:Results