927-P: Effect of Oral Semaglutide with or without Background SGLT2i in Patients with T2D: Subgroup Analysis of PIONEER 4
Authors: PRATLEY RICHARD E. , BAUER ROBERT , INZUCCHI SILVIO E. , KHUNTI KAMLESH , KREINER ESKIL B. , LAURSEN PETER N. , MEIER JURIS J. 
Published: June 2020

Glucagon-like peptide-1 receptor agonists (GLP-1RA) and SGLT2 inhibitors (SGLTi) are widely used to treat type 2 diabetes (T2D) but trial data on their combined use are limited. We report the first data on oral semaglutide in combination with SGLT2i. This was a post-hoc subgroup analysis of the 52-week, double-blind, double-dummy PIONEER 4 trial (NCT02863419), in which patients with T2D uncontrolled on metformin with or without SGLT2i were randomized 2:2:1 to once-daily oral semaglutide 14 mg, subcutaneous (s.c.) liraglutide 1.8 mg or placebo. Glycated hemoglobin (HbA1c) and body weight (BW) data presented are for the trial product estimand (on-trial product without rescue medication). In total, 183 (26%) of 711 patients were receiving SGLT2i treatment at baseline which continued throughout the trial. Subgroups of patients receiving SGLT2i had a lower percentage of females, slightly longer mean T2D duration and higher BW. Changes in HbA1c and BW were similar in patients receiving oral semaglutide or s.c. liraglutide with or without SGLT2i. Occurrence of most gastrointestinal adverse events was similar in patients on GLP-1RA with and without SGLT2i.
In conclusion, improvements in HbA1c and BW after one year as well as safety profile were similar in patients on GLP-1RA with or without background SGLT2i.

Disclosure
R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. R. Bauer: Employee; Self; Novo Nordisk A/S. S.E. Inzucchi: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Abbott, Merck & Co., Inc., vTv Therapeutics. K. Khunti: Advisory Panel; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Board Member; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Consultant; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier. Speaker’s Bureau; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. E.B. Kreiner: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. P.N. Laursen: Employee; Self; Novo Nordisk A/S. J.J. Meier: Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi.

Funding
Novo Nordisk A/S