Visual Abstract
Early achievement of near-normal HbA1c is associated with a reduced risk of future complications in type 2 diabetes (T2D) and may help motivate patients (pts) to maintain treatment. We conducted a post-hoc analysis of the PIONEER 1 study to look at the impact of early initiation of oral semaglutide (sema) on glycemic efficacy, body weight (BW), and achievement of targets. Pts on diet and exercise were randomized to oral sema 3, 7, or 14 mg once daily, or placebo (pbo). HbA1c and BW reduction, and achievement of HbA1c targets (<7%, ≤6.5%, <6%) were assessed at 26 weeks in pts with T2D duration ≤1 year and >1 year for comparison. Greater HbA1c and BW reductions were seen for oral sema 14 mg vs. pbo for both duration ≤1 year (-1.6% vs. -0.4%; -4.3 kg vs. -1.6 kg) and >1 year (-1.4% vs. 0.2%; -4.0 kg vs. -1.4 kg); the subgroup interaction (≤1 vs. >1 year) was significant for HbA1c (p=0.04) but not BW. A high proportion of pts initiating oral sema within ≤1 year of T2D diagnosis reached glycemic targets, including HbA1c <6.0% in 45% of pts on oral sema 14 mg (vs. 31% in the >1‑year group; Figure); subgroup interactions were not significant.
In conclusion, initiation of oral sema in pts within ≤1 year of T2D diagnosis resulted in robust HbA1c and BW reductions, and attainment of glycemic targets, including near-normal HbA1c. These observations support early initiation of therapy and further study.
V. R. Aroda: Consultant; Self; Applied Therapeutics, Duke, Novo Nordisk, Pfizer Inc., Sanofi, Employee; Spouse/Partner; Janssen, Merck, Research Support; Self; Applied Therapeutics, Eli Lilly and Company, Fractyl, Medpace, Medpace, Novo Nordisk, Premier, Sanofi, Stock/Shareholder; Spouse/Partner; Janssen, Merck. L. Bardtrum: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. K. Kallenbach: Employee; Self; Novo Nordisk. A. Moeller nielsen: Employee; Self; Novo Nordisk A/S. J. Rosenstock: Board Member; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Consultant; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Research Support; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Genentech, Inc., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Oramed Pharmaceuticals, Inc., Pfizer Inc., REMD Biotherapeutics, Sanofi. E. C. Morales-villegas: Research Support; Self; Allergan plc, Amgen Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi-Aventis, Takeda Pharmaceutical Company Limited. M. J. Davies: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Limited (UK), Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Self; AstraZeneca, NIHR Leicester Biomedical Research Centre, Novo Nordisk, Speaker’s Bureau; Self; Astra Zeneca Pharma India Ltd, Boehringer Ingelheim (China), Boehringer Ingelheim (Philippines), Inc., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Limited (UK), Boehringer Ingelheim Saudi Arabia Trading, Boehringer Ingelheim Singapore Pte. Ltd, Boehringer Ingelheim Sp. Z o. o., Eli Lilly and Company, Napp Pharmaceuticals, Novo Nordisk, Novo Nordisk A/S, S. C. Sanofi Romania SRL, Sanofi K. K.
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