137-LB: Safety Assessment of SAR341402 and NovoLog When Administered through an Insulin Pump

SAR341402 (SAR-Asp) is a biosimilar/follow-on insulin to NovoLog® (NN-Asp). This non-confirmatory, randomized, open-label, 2x4 week, 2 arm crossover study in 45 T1D patients (NCT03436498) was designed to assess the safety of SAR-Asp and NN-Asp when used in pumps (CSII) in terms of infusion set occlusions (ISO). The primary safety endpoint was to assess the number of patients with ISO using SAR-Asp and NN-Asp. ISO was defined as infusion set change due to failure to correct hyperglycemia (plasma glucose ≥250 mg/dL) by insulin bolus via the pump. The secondary safety endpoint was to assess the incidence of all cases of unexplained hyperglycemia events whether or not corrected by a bolus through the insulin pump with no apparent materials defects, medical, dietary, insulin dosing, or pump failure including infusion set occlusions as defined in the primary safety endpoint. The number of patients reporting at least one ISO was: 14/43 (32.6%) patients on SAR-Asp and 12/43 (27.9%) on NN-Asp (Table 1). The number of patients with at least one unexplained hyperglycemia was 31/43 (72.1%) on SAR-Asp and 32/43 (74.4%) on NN-Asp. The total number of unexplained hyperglycemia was 329: 154 on SAR-Asp and 175 on NN-Asp. In this study SAR-Asp and NN-Asp were well-tolerated. There was no difference in the safety profiles including ISO, hyperglycemia, hypoglycemia, hypersensitivity and injection site reactions when used in CSII. Disclosure J. Thrasher: Advisory Panel; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi, Senseonics. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Sanofi. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc. S. Polsky: Consultant; Self; Jaeb Center for Health Research. Research Support; Self; Barbara Davis Center for Diabetes, Children’s Diabetes Foundation, Dexcom, Inc., Eli Lilly and Company, JDRF, Leona & Harry Helmsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi US. L. Hovsepian: None. I.K. Nowotny: Employee; Self; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Self; Sanofi. B. Bois De Fer: Employee; Self; ITM Self; ITM Self; Sanofi-Aventis. Research Support; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Gan & Lee Pharmaceuticals, Jaeb Center for Health Research, KOWA Research Institute, Inc, Medtronic MiniMed, Inc., Merck Research Laboratories, Mylan GmbH, Novo Nordisk Inc., Roche Diabetes Care, Sanofi, Theracos Sub, LLC. Speaker’s Bureau; Self; AstraZeneca, Eli Lilly and Company, Sanofi-Aventis. S.K. Garg: Advisory Panel; Self; Eli Lilly and Company, Roche Pharma, Sanofi-Aventis, Zealand Pharma A/S. Research Support; Self; Eli Lilly and Company, WebMD. Funding Sanofi