Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Phase 3 Completed 321 enrolled Sanofi

RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.

Timeline

Start: 2016-05-09
Primary completion: 2018-05
Completion: 2018-05

Outcome

Met primary endpoint

paper Change in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), PMID 32295808 ↗

paper confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], P < 0.0001). PMID 32295808 ↗

Publications

Results Watada H, Takami A, Spranger R, Amano A, Hashimoto Y, Niemoeller E. Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. Diabetes Care. 2020 Jun;43(6):1249-1257. doi: 10.2337/dc19-2452. Epub 2020 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lixisenatide	Peptide	—	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	—	Subcutaneous