whether semaglutide reduces MACE in overweight and obese people. With regulators, drugmakers and payers pulling in similar directions, real-world evidence is likely to become a more central feature of drug development despite its many shortcomings. An update on the progress of the highly significant PIONEER trial was given at the 55th annual European Association for the Study of Diabetes (EASD) meeting in Barcelona. Lisa LaMotta Bethesda, MD, National Library of Medicine, 2019. The use of subcutaneous semaglutide has previously been associated with a higher rate of diabetic retinopathy–related complications compared with placebo, which is consistent with the phenomenon of early worsening of preexisting diabetic retinopathy secondary to an initial, rapid improvement in glycemic control (6,35). Baseline characteristics were well balanced between treatment groups (Table 1). Available from, Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies, Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial, Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial, Institutional Subscriptions and Site Licenses, Special Podcast Series: Therapeutic Inertia, Special Podcast Series: Influenza Podcasts, http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0883/-/DC1, http://www.diabetesjournals.org/content/diabetes-core-update-podcasts, http://www.diabetesjournals.org/content/license, https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html, https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9-R1EWG_Step2_Guideline_2017_0616.pdf, https://clinicaltrials.gov/ct2/show/NCT03811561, Clinical Therapeutics/New Technology-Oral Agents. © 2019 by the American Diabetes Association. More patients prematurely discontinued treatment because of adverse events with oral semaglutide versus empagliflozin mainly as a result of gastrointestinal symptoms associated with dose escalation. H.W.R., J.R., L.H.C., C.D., J.G., S.Ø.L., I.L., A.L.S., M.B.T., and E.M. were responsible for the acquisition, analysis, or interpretation of data and the drafting or critical revision of the manuscript for important intellectual content. We use cookies to ensure that we give you the best experience on our website. reports clinical research for Novo Nordisk, Janssen, Eli Lilly, and Sanofi and lecturing for Sanofi and Boehringer Ingelheim.
In addition, the authors thank Andy Bond of Spirit Medical Communications Group Ltd. for medical writing and editorial assistance and Brian Bekker Hansen of Novo Nordisk for reviewing the manuscript.
* A complete list of investigators in the Peptide Innovation for Early Diabetes Treatment 2 trial (PIONEER 2) is provided in the Supplementary Data. B: Estimated changes from baseline in HbA1c at weeks 26 and 52. This estimand aims at reflecting the effect of oral semaglutide compared with empagliflozin without the confounding effect of rescue medication. Yet obesity has traditionally been a tough market to crack. Through to week 26, 17 (4.1%) patients initiated additional antidiabetic medication in the oral semaglutide group; in 8 (1.9%) of these patients, it was rescue medication. This estimand reflects the intention-to-treat principle as defined in International Council on Harmonization (ICH) E9 (24).
This search revealed only clinical pharmacology studies and a phase 2 dose-finding trial with oral semaglutide, which were used to inform the design of the current phase 3a PIONEER 7 trial. Trial product discontinuation and initiation of rescue medication are accounted for by the treatment policy strategy for the treatment policy estimand and by the hypothetical strategy for the trial product estimand as defined in draft ICH E9 (R1) (25). Pharmacologic approaches to glycemic treatment: Management of hyperglycemia in type 2 diabetes, 2018. In both groups, premature discontinuations mainly occurred in the first 16 weeks of treatment.
L.H.C. Oral semaglutide 14 mg provided a superior reduction in HbA1c compared with empagliflozin 25 mg at week 26 when evaluated by the treatment policy estimand (regardless of rescue medication use or trial product discontinuation) (–1.3% vs. –0.9% [–14 vs. –9 mmol/mol]; estimated treatment difference [ETD] –0.4% [95% CI –0.6, –0.3] [–5 mmol/mol (–6, –3)]; P < 0.0001 for noninferiority and superiority) (Fig. Cardiovascular safety has been confirmed, with an indication of benefit, by a nonsignificant 21% risk reduction in major adverse cardiovascular events versus placebo (17).
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