Study S001367

A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)

ClinicalTrials.gov record

Registration

Registration: NCT03767543
Acronym: LixilanOne CAN
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 265
Start: 2019-03-11
Primary completion: 2020-10-23
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1215-0238

Registered primary outcomes

Change in glycated hemoglobin (HbA1c)% [Baseline to Week 26]

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
R0006120	Ease of Use of the iGlarLixi SoloStar Pen from the LixiLan ONE CAN Pen Sub-Study: Questionnaire Findings from People Living with Type 2 Diabetes and Their HealthCare Providers. Yale JF, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Nonrandomized study	PMID 36574199 DOI	cites ClinicalTrials.gov:NCT03767543; registry reference DERIVED:36574199
R0015412	Comparing a daily versus weekly titration algorithm in people with type 2 diabetes switching from basal insulin to iGlarLixi in the LixiLan ONE CAN randomized trial. Hramiak I, Diabetes, obesity & metabolism	2022	Randomized trial	PMID 35670659 DOI	cites ClinicalTrials.gov:NCT03767543; registry reference DERIVED:35670659
R0047370	Lixilan ONE CAN: Randomisierte Studie zum Vergleich eines täglichen vs. wöchentlichen Titrationsalgorithmus für den Wechsel von Basalinsulin zur Fixkombination iGlarLixi bei Typ-2-Diabetespatienten in Kanada IRENE M. HRAMIAK, Diabetologie und Stoffwechsel	2022	Other	DOI	cites ClinicalTrials.gov:NCT03767543
R0050908	95-LB: LixilanONE CAN: Randomized Trial Comparing a Daily vs. Weekly Titration Algorithm for Switching from Basal Insulin to iGlarLixi Fixed-Ratio Combination in People with T2DM in Canada IRENE M. HRAMIAK, Diabetes	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03767543