101-OR: Efficacy and Safety of Once-Weekly Semaglutide 2.0 vs. 1.0 mg for Type 2 Diabetes: SUSTAIN FORTE Randomized Trial

Abstract

Once-weekly (OW) subcutaneous semaglutide 0.5 and 1.0 mg are approved maintenance doses for type 2 diabetes (T2D) treatment. We hypothesized that a higher dose of 2.0 mg would provide additional glycemic control with more patients achieving treatment targets vs. 1.0 mg. SUSTAIN FORTE (NCT03989232) was a randomized, double-blind, phase 3b trial investigating the efficacy and safety of OW semaglutide 2.0 vs. 1.0 mg after 40 weeks of treatment in 961 adults with T2D in need of treatment intensification (HbA1c 8.0-10.0%) on stable metformin ± sulfonylurea. All participants initiated semaglutide treatment with the 0.25 mg dose, doubling every 4 weeks until target dose was reached. The primary objective was to establish superiority of semaglutide 2.0 vs. 1.0 mg on glycemic control; secondary objectives included comparison of the effect on body weight (BW) (confirmatory), safety and tolerability. Baseline characteristics and key results are shown in the Table. Superior HbA1c and BW reductions were shown with semaglutide 2.0 vs. 1.0 mg and a greater proportion of participants achieved HbA1c In conclusion, semaglutide 2.0 mg is superior to 1.0 mg in reducing HbA1c and BW, with a comparable safety profile. Disclosure J. P. Frias: Consultant; Self; 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi, Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, CymaBay Therapeutics, Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi, Speaker’s Bureau; Self; Merck & Co., Inc., Sanofi. J. B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Fortress Biotch, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego Inc., Stability Health, Zealand Pharma A/S, Other Relationship; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, vTv Therapeutics, Research Support; Self; NovaTarg Therapeutics, Novo Nordisk, Sanofi, Tolerion, Inc., vTv Therapeutics, Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. P. Auerbach: Employee; Self; Novo Nordisk A/S. H. S. Bajaj: Other Relationship; Self; Eli Lilly and Company, Novo Nordisk, Research Support; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Kowa Pharmaceuticals America, Inc., Merck & Co., Inc., Sanofi, Tricida, Inc. Y. Fukushima: None. I. Lingvay: Advisory Panel; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Consultant; Self; TARGET PharmaSolutions, Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Zealand Pharma A/S, Research Support; Self; Mylan N. V., Sanofi. S. Macura: Employee; Self; Novo Nordisk A/S. A. L. Sondergaard: Stock/Shareholder; Self; Novo Nordisk A/S, Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. T. Tankova: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Medtronic, Novartis AG, Sanofi, Worwag Pharma, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk Pharma Ltd., Sandoz International GmbH, Sanofi, Servier Laboratories. N. Tentolouris: None. Funding Novo Nordisk A/S