LivingGLP1
Study S000170

A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Antidiabetic Drug(s)

Registration

Registration
NCT03798054
Acronym
Lixilan-O-AP
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
878
Start
2019-02-15
Primary completion
2021-03-01
Lead sponsor
Sanofi
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:Insulin glargine/Lixisenatide (HOE901/AVE0010); DRUG:Insulin glargine (HOE901); DRUG:Lixisenatide (AVE0010); DRUG:Metformin; DRUG:SGLT2 inhibitor
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1190-7669

Registered primary outcomes

  • Change in HbA1c [From Baseline to Week 24]

Linked records (4)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R00457331748-P: IGlarLixi Improves PPG and DTIR in Asian People with T2D (PwT2D): Post Hoc Pooled Analysis of Ph3 Studies
WENJIAN LIN, Diabetes
2026OtherDOIcites ClinicalTrials.gov:NCT03798054
R0010585iGlarLixi provides a higher derived time-in-range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis.
Guo X, Diabetes, obesity & metabolism
2023Randomized trialPMID 36999231DOIcites ClinicalTrials.gov:NCT03798054; registry reference DERIVED:36999231
R0013321Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial.
Yang W, Diabetes, obesity & metabolism
2022Randomized trialPMID 35441412DOIcites ClinicalTrials.gov:NCT03798054; registry reference BACKGROUND:35441412
R0046797850-P: Greater HbA1c Reduction with iGlarLixi vs. Insulin Glargine and Lixisenatide Regardless of Levels at Screening: Subgroup Analysis of the LixiLan-O Asia Pacific Trial
YIFAN HE, Diabetes
2022Randomized trialDOIcites ClinicalTrials.gov:NCT03798054