1762-P: THDB0206 Injection (BioChaperone Lispro, BCLIS) Improves Postprandial and Daily Glucose Control vs. Lispro (LIS) in Chinese Patients with Type 2 Diabetes (T2D)

Introduction and Objective: BCLIS is an ultra-rapid insulin lispro formulation designed to more closely match physiological insulin secretion. This open-label multicenter phase 3 trial evaluated the efficacy and safety of BCLIS compared to LIS in people with T2D in China. Methods: After an 8-week run-in period on LIS and glargine, 1040 subjects with T2D were randomized 3/2 to 26 weeks of treatment on glargine + 3 boluses of either BCLIS or LIS. Metformin was continued during the trial. Primary endpoint was A1C change from baseline to week 26, with multiplicity adjusted objectives for standardized meal test postprandial glucose excursions (PPGE). Results: Non inferiority was confirmed for the primary endpoint for BCLIS: A1C was reduced by 0.65% (BCLIS) and 0.57% (LIS): estimated treatment difference of -0.07% [95% CI -0.18; 0.03]. BCLIS was superior to LIS in controlling 1- and 2-h meal test PPGE at week 26. Significantly more patients achieved A1C target of 7% with BCLIS (49.8% vs. 43.8%, p=0.03). Mean 10-pt SMBG was significantly reduced for BCLIS vs. LIS by -0.44 mmol/L [95% CI -0.67; -0.21] with significant reductions at each meal (Fig). There were no significant treatment differences in severe or overall hypoglycemia rates and in incidence of overall treatment-emergent adverse events. Conclusion: This large phase 3 clinical trial shows that BCLIS improves postprandial glucose control compared to LIS in Chinese subjects with T2D. Disclosure Q. Wang: Employee; Current; Tonghua Dongbao Pharmaceutical Co., Ltd. C. Mégret: Employee; Current; ADOCIA. Stock/Shareholder; Current; ADOCIA. L. Zhang: Employee; Current; Tonghua Dongbao Pharmaceutical Co., Ltd. M. Gaudier: Employee; Current; ADOCIA. Stock/Shareholder; Current; ADOCIA. C. Pei: Employee; Current; Tonghua Dongbao Pharmaceutical Co., Ltd. O. Soula: Board Member; Current; ADOCIA. Stock/Shareholder; Current; ADOCIA. Employee; Current; ADOCIA. T. Heise: Research Support; Ended; Afon Technology. Research Support; Current; Betagenon AB, Civica, Corteria Pharmaceuticals. Research Support; Ended; Cytoki Pharma. Research Support; Current; DioGenX, ENYO Pharma, Gan & Lee Pharmaceuticals. Consultant; Current; Gan & Lee Pharmaceuticals. Research Support; Current; Nanexa, Neodyne Biosciences, Sam Chun Dang. Research Support; Ended; Liom. Research Support; Current; Sun Pharmaceutical Industries Ltd., Zealand Pharma A/S. Other - Travel Grants; Current; Zealand Pharma A/S. Research Support; Current; AstraZeneca, Biocon, Eli Lilly and Company. Speaker's Bureau; Current; Eli Lilly and Company. Research Support; Current; Novo Nordisk, Roche Diagnostics. Consultant; Current; i2o Therapeutics. Speaker's Bureau; Current; Novo Nordisk. X. Li: Consultant; Current; Tonghua Dongbao Pharmaceutical Co., Ltd.