1032-P: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed-Ratio Combination vs. Insulin Glargine in Japanese Patients with T2DM

Abstract

The fixed ratio combination of insulin glargine/lixisenatide (iGlarLixi) has been shown in a Western population to improve glycemic control in a convenient single daily injection. This open-label trial assessed the efficacy and safety of 26-week treatment of iGlarLixi and insulin glargine (iGlar) in Japanese patients with T2DM inadequately controlled on basal insulin and oral antidiabetic drugs. After a 12-week run-in with metformin and iGlar, patients were randomized to iGlarLixi (n=255) or iGlar (n=257). Starting from a mean baseline (BL) HbA1c of 8.25%, the decrease in the iGlarLixi group was significantly greater than in the iGlar group (LS mean difference [SE]: -0.74% [0.063], p<0.0001) (Figure). Significantly more patients reached the HbA1c target of <7% at Week 26 with iGlarLixi than with iGlar (51.8% vs. 16.0%, p<0.0001). Change in body weight from BL to Week 26 was -0.51 kg with iGlarLixi and +0.55 kg with iGlar (p<0.0001). Both treatments were well tolerated. Documented symptomatic hypoglycemia (≤70 mg/dL) was similar in the two treatment groups (iGlarLixi: 18.8%, iGlar: 16.7%). Nausea was reported in 16.9% (iGlarLixi) and 0.8% (iGlar). In conclusion, iGlarLixi showed superior glycemic control to iGlar, with a beneficial effect on body weight, no additional risk of hypoglycemia, and lower rate of nausea than reported with lixisenatide. Disclosure H. Kaneto: Research Support; Self; Astellas Pharma Inc., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co ., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Astellas Pharma Inc., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co ., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. A. Takami: Employee; Self; Sanofi K.K. R. Spranger: Employee; Self; Sanofi-Aventis Deutschland GmbH. A. Amano: Employee; Self; Sanofi K.K. D. Watanabe: Employee; Self; Sanofi K.K. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Funding Sanofi K.K.