parallel randomized trial

LIXILAN JP-O2

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 on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

Type 2 diabetes (adults)NCT02752828S002305

Design

Randomized: 521
Start year: 2016
Treatment: 26 weeks, follow-up 26 weeks
Countries: Japan
Sponsor: Sanofi (industry)
Eligibility: HbA1c 7.5 to 9.5 percent; FPG 10.0 mmol/L or less; up to two OADs or three with DPP4i

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	existing OADs; DPP4 inhibitors stopped at randomization; lifestyle: not reported	260	260
A2	Insulin glargine Insulin glargine	existing OADs; DPP4 inhibitors stopped at randomization; lifestyle: not reported	261	260

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
hba1c	mean (percent)	8.08	8.01

Analyses this trial contributes to

Results

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

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	14.2			260	not stated; modified itt; R0009500:Results
	A2	events	12.3			260	not stated; modified itt; R0009500:Results