Do Baseline Characteristics Impact Efficacy Of Efpeglenatide Qw In Uncontrolled Type 2 Diabetes?

Once-weekly (QW), subcutaneous efpeglenatide (EFPEG) is a long-acting GLP-1 RA for T2D management. In EXCEED 203 (NCT02057172), EFPEG QW significantly reduced HbA1c vs. placebo (PBO) for early T2D (naïve/metformin monotherapy). This post hoc subanalysis explored the efficacy of EFPEG QW (pooled low [1 and 2 mg] or high dose [3 and 4 mg]) vs. PBO stratified by baseline characteristics: HbA1c (<8%; 8‒9%; >9%), BMI (<30; ≥30 kg/m2), FPG, T2D duration, and age (<median; ≥median). Change in HbA1c, FPG, and BMI from baseline to Week 13 was compared within and across baseline characteristic subgroups. Within subgroups, HbA1c and FPG reductions were significantly greater for patients with higher HbA1c at baseline with high-dose EFPEG (p≤0.0015) according to HbA1c and FPG subgroups; low-dose EFPEG followed the same trend in most cases. HbA1c and FPG reduction were similar for BMI, T2D duration, and age subgroups; BMI outcomes did not significantly differ within subgroups. There were numerically greater LS mean reductions in HbA1c and FPG from baseline vs. PBO, which were significant for high-dose EFPEG, for all subgroups (except HbA1c >9% for FPG; Table); reductions were greater with high-dose vs. low-dose EFPEG. For BMI, there was a trend for reductions vs. PBO with high-dose EFPEG (Table). In conclusion, high-dose EFPEG demonstrated significant reductions in HbA1c vs. PBO for all baseline characteristic subgroups. Disclosure G.E. Dailey: Research Support; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Sanofi US. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. C. Morales: Other Relationship; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. U. Wendisch: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S. Stock/Shareholder; Self; Novartis AG, Novo Nordisk A/S. M.E. Trautmann: Consultant; Self; CeQur Corporation, Hanmi Pharm. Co., Ltd., Intarcia Therapeutics, Inc., Oramed Pharmaceuticals, ProSciento, Servier. Stock/Shareholder; Self; Lilly Diabetes. M. Hompesch: Stock/Shareholder; Self; ProSciento. I. Choi: Employee; Self; Hanmi Pharm. Co., Ltd. J. Kang: Employee; Self; Hanmi Pharm. Co., Ltd. C.H. Sorli: Employee; Self; Sanofi. I. Ogbaa: Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. Other Relationship; Self; Sanofi. J.A. Stewart: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. K. Yoon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc. Speaker's Bureau; Self; Takeda Pharmaceutical Company Limited. Funding Hanmi Pharmaceutical, Co., Ltd.; Sanofi