Study S002110

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)

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT03798080
Acronym: Lixilan-L-CN
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 426
Start: 2019-02-19
Primary completion: 2020-12-01
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine/Lixisenatide (HOE901/AVE0010); DRUG:Insulin glargine (HOE901); DRUG:Metformin
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1190-7781

Registered primary outcomes

Change in HbA1c [From Baseline to Week 30]

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.

Record	Title	Year	Design	Identifiers	Link basis
R0045733	1748-P: IGlarLixi Improves PPG and DTIR in Asian People with T2D (PwT2D): Post Hoc Pooled Analysis of Ph3 Studies WENJIAN LIN, Diabetes	2026	Other	DOI	cites ClinicalTrials.gov:NCT03798080
R0011530	iGlarLixi effectively reduces residual hyperglycaemia in Chinese people with type 2 diabetes on basal insulin: A post hoc analysis of the LixiLan-L-CN study. Yuan X, Diabetes, obesity & metabolism	2024	Other	PMID 39360440 DOI	cites ClinicalTrials.gov:NCT03798080; registry reference DERIVED:39360440
R0010585	iGlarLixi 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	2023	Randomized trial	PMID 36999231 DOI	cites ClinicalTrials.gov:NCT03798080; registry reference DERIVED:36999231
R0014540	Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Yuan X, Diabetes, obesity & metabolism	2022	Randomized trial	PMID 35762489 DOI	cites ClinicalTrials.gov:NCT03798080; registry reference BACKGROUND:35762489