drugset / Trial / NCT03767543
Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling. Secondary Objective: To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).
Timeline
- Start
- 2019-03-11
- Primary completion
- 2020-10-23
- Completion
- 2020-10-23
Outcome
Met primary endpoint
paper At 26 weeks, daily titration of iGlarLixi was not inferior to a weekly titration for both the prespecified primary endpoint PMID 35670659 ↗
paper LS mean difference: 0.32%; 95% CI [0.07, 0.57]; P < .0001 PMID 35670659 ↗
Publications
- Yale JF, Roborel de Climens A, Aggarwal N, Dex T, Gerstein HC, Harris S, Hramiak I, Stewart J, Leiter LA. 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. Diabetes Ther. 2023 Feb;14(2):377-386. doi: 10.1007/s13300-022-01353-6. Epub 2022 Dec 27.
- Hramiak I, Gerstein HC, Leiter LA, Yale JF, Bajaj HS, Stewart J, Toutounji MJ, Harris SB. 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. Diabetes Obes Metab. 2022 Oct;24(10):1998-2007. doi: 10.1111/dom.14787. Epub 2022 Jun 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lixisenatide | Peptide | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |