Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: An Individual Patient Data Meta-Analysis

摘要

Introduction: Lixisenatide is a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus (T2DM). Its efficacy and safety have been assessed in a series of phase 3 studies included in the GetGoal program. In these studies, lixisenatide was found to be superior to placebo in glycemic control. The aim of this meta-analysis was to assess the safety and efficacy of lixisenatide as an adjunct therapy in Asian patients with T2DM in adequately controlled with oral antidiabetic drugs (OADs). Methods: We performed a meta-analysis from five lixisenatide phase 3 studies. In each of these multiethnic studies, patients with T2DM inadequately controlled (glycated hemoglobin, HbA1c C7%) with established OADs were randomized to lixisenatide or placebo for 24 weeks, with a balanced distribution of Asian patients in these two arms (503 and 338 patients in the intent-to-treat population, respectively). Results: Lixisenatide was superior to placebo in reducing HbA1c (weighted, total mean difference -0.57%; P = 0.002). More patients treated with lixisenatide versus placebo achieved HbA1c targets of < =7% (49.1% vs. 28.4%, P = 0.003). Lixisenatide was superior to placebo in lowering 2-h postprandial glucose (PPG) (weighted, total mean difference -5.50mmol/l, P = 0.0005). More patients treated with lixisenatide versus placebo achieved 2-h PPG targets of < =7.8 mmol/l (39.2% vs. 2.2%, P< 0.0001). More patients treated with lixisenatide versus placebo achieved both an HbA1c target of < =7% and a 2-h PPG target of < =10 mmol/l (34.8% vs. 2.69%, P < 0.00001). The body weight of the lixisenatide group tended to decrease. Lixisenatide was generally well tolerated. Conclusion: Lixisenatide as an adjunct therapy can significantly improve the glycemic control of Asian patients with type 2 DM who do not meet targets for glycemic control with an established OAD regimen. Funding: Sanofi (China) Investment Co., Ltd., Shanghai, China.