parallel randomized trial

LIXILAN JP-L

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Type 2 diabetes (adults)NCT02752412S000356

Design

Randomized: 513
Start year: 2016
Treatment: 26 weeks
Countries: Japan
Sponsor: Sanofi (industry)
Eligibility: Japanese adults; T2D over 1 year; HbA1c 7.5 to 9.5 on basal insulin plus 1 or 2 oral drugs

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
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 1 U to 1 ug	metformin; lifestyle: not reported	255	255
A2	Insulin glargine Insulin glargine 100 U/mL	metformin; lifestyle: not reported	257	257

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
bmi	mean (kg/m2)	25.32	24.88
bmi	sd (kg/m2)	4.18	3.85

Analyses this trial contributes to

Results

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

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	52.0			255	not stated; modified itt; R0008233:Results
26	A2	responders	16.1			257	not stated; modified itt; R0008233:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 255	while on treatment; randomized; R0008233:Supplement Table S1
	A2	events				0 / 257	while on treatment; randomized; R0008233:Supplement Table S1

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 255	while on treatment; randomized; R0008233:Supplement Table S1
	A2	events				11 / 257	while on treatment; randomized; R0008233:Supplement Table S1

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 255	while on treatment; randomized; R0008233:Supplement Table S1
	A2	events				4 / 257	while on treatment; randomized; R0008233:Supplement Table S1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				43 / 255	while on treatment; randomized; R0008233:Supplement Table S1
	A2	events				2 / 257	while on treatment; randomized; R0008233:Supplement Table S1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 255	while on treatment; randomized; R0008233:Supplement Table S1
	A2	events				3 / 257	while on treatment; randomized; R0008233:Supplement Table S1