670-P: Time Spent in Glycemic Control after Initiating Treatment with Oral Semaglutide vs. Empagliflozin: An Exploratory Analysis of the PIONEER 2 Trial
Authors: ROSENSTOCK JULIO , CARIOU BERTRAND , CHRISTIANSEN ERIK , HERTZ CHRISTIN L. , MONTANYA EDUARD , NIELSEN MORTEN ABILDLUND , KNOP FILIP K. 
Published: June 2021

A standard objective in the management of T2D is the achievement and maintenance of HbA1c targets, but the duration of time that patients spend within glycemic control targets has not been previously reported for oral semaglutide (sema). In this exploratory analysis, the duration of time that patients were in glycemic control (HbA1c &lt;7.0% and &lt;6.5%) during the 52-week PIONEER 2 trial (NCT02863328) was assessed. Patients with uncontrolled T2D (N=822; HbA1c 7.0─10.5%) were randomized to oral sema 14 mg once daily or empagliflozin (empa) 25 mg once daily. Both drugs underwent dose escalation, with oral sema starting at 3 mg, increasing to 7 mg after 4 weeks, and 14 mg after 8 weeks. Empa was initiated at 10 mg and escalated to 25 mg after 8 weeks. For this analysis, outcomes were evaluated using the on-treatment without rescue medication observation period, in all randomized patients. Baseline characteristics were similar between treatment arms. Mean baseline HbA1c for both arms was 8.1%. A greater proportion of patients receiving oral sema vs. empa achieved HbA1c &lt;7.0% at some point during the study (78% vs. 60%), and for the following lengths of time that HbA1c remained &lt;7%: ≥14 weeks (65% vs. 48%); ≥26 weeks (56% vs. 38%); and ≥38 weeks (46% vs. 28%). During treatment, the overall mean duration of time spent at HbA1c &lt;7.0% and &lt;6.5% was 27 weeks and 16 weeks, respectively, for oral sema, and 19 weeks and 7 weeks for empa. Based on the trial product estimand, the odds of patients achieving HbA1c &lt;7.0% at both week 26 and 52 were significantly greater with oral sema vs. empa (estimated odds ratio 4.12 [95% CI 2.94, 5.76]; p&lt;0.0001).
In conclusion, despite an 8-week dose escalation schedule and a mean baseline HbA1c of 8.1%, nearly half of patients receiving oral sema achieved glycemic control (HbA1c &lt;7.0%) for more than 70% of the 52-week treatment duration. These data suggest that patients spend more time in glycemic control during treatment with oral sema vs. empa.

Disclosure
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. B. Cariou: Board Member; Self; Bristol-Myers Squibb Company, Gilead Sciences, Inc., Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk, Sanofi, Research Support; Self; Amgen Inc., AstraZeneca, Regeneron Pharmaceuticals Inc., Speaker’s Bureau; Self; Abbott Diabetes, Akcea Therapeutics. E. Christiansen: None. C. L. Hertz: Advisory Panel; Spouse/Partner; SNIPR BIOME APS, Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. E. Montanya: Advisory Panel; Self; Sanofi, Consultant; Self; Merck Sharp & Dohme Corp., Employee; Spouse/Partner; Almirall, S. A., Research Support; Self; Menarini Group, Roche Diagnostics SL, Speaker’s Bureau; Self; Novo Nordisk A/S. M. Abildlund nielsen: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Lundbeck, Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. F. K. Knop: Advisory Panel; Self; MSD Corporation, Novo Nordisk A/S, Sanofi, Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Pharmacosmos, Zealand Pharma A/S, Research Support; Self; Novo Nordisk A/S, Zealand Pharma A/S, Speaker’s Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S.

Funding
Novo Nordisk A/S