LivingGLP1
Study S001125

A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT02787551
Acronym
LixiLan-G
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
514
Start
2016-07-06
Primary completion
2018-05-25
Lead sponsor
Sanofi
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:Insulin glargine/lixisenatide fixed ratio combination; DRUG:liraglutide; DRUG:exenatide; DRUG:exenatide extended-release; DRUG:albiglutide; DRUG:dulaglutide; DRUG:Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:2014-004850-32; OTHER:U1111-1168-4639; NIH:2014

Registered primary outcomes

  • Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period [Baseline, Week 26]
  • Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period [Baseline, Week 52]

Linked records (9)

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
R0006249Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ß-cell function in people with type 2 diabetes.
Ferrannini E, Diabetes, obesity & metabolism
2022Randomized trialPMID 35257461DOIcites ClinicalTrials.gov:NCT02787551; registry reference DERIVED:35257461
R0006703Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results.
Guja C, Diabetes therapy : research, treatment and education of diabetes and related disorders
2022Randomized trialPMID 34894329DOIcites ClinicalTrials.gov:NCT02787551; registry reference DERIVED:34894329
R0006420Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study.
Blonde L, Diabetes care
2021Randomized trialPMID 33468520DOIcites ClinicalTrials.gov:NCT02787551; registry reference DERIVED:33468520
R0051757Umstellung auf iGlarLixi gegenüber der weitergeführten Behandlung mit einem GLP-1-Rezeptoragonisten bei unzureichend kontrolliertem Typ-2-Diabetes: die randomisierte LixiLan-G-Studie
AL Birkenfeld, Diabetologie und Stoffwechsel
2021Other trialDOIcites ClinicalTrials.gov:NCT02787551
R004997588-LB: Similar Efficacy and Safety of IGlarLixi When Initiated in Patients with Type 2 Diabetes (T2D) with or without Concomitant Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) Use in a Randomized Controlled Trial (RCT) and Real-World Setting
Julio Rosenstock, Diabetes
2020Randomized trialDOIcites ClinicalTrials.gov:NCT02787551
R0007263Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.
Blonde L, Diabetes care
2019Randomized trialPMID 31530665DOIcites ClinicalTrials.gov:NCT02787551; registry reference DERIVED:31530665
R00454271146-P: Switching to iGlarLixi vs. Continued Treatment of GLP-1RA: Comparative Analysis by Daily or Weekly GLP-1RAs in the LixiLan-G Trial
Julio Rosenstock, Diabetes
2019Randomized trialDOIcites ClinicalTrials.gov:NCT02787551
R00457941139-P: Influence of Screening HbA1c Levels on Glucose Control Achieved when Switching to iGlarLixi in T2D Inadequately Controlled on GLP-1RA and OAD(s)
Stefano Del Prato, Diabetes
2019Randomized trialDOIcites ClinicalTrials.gov:NCT02787551
R0046862149-OR: LixiLan-G: A Randomized Trial Assessing Switching to iGlarLixi vs. Continuation of Daily or Weekly GLP-1RA in T2D Inadequately Controlled by a GLP-1RA and OAD(s)
Lawrence Blonde, Diabetes
2019Randomized trialDOIcites ClinicalTrials.gov:NCT02787551