The clinical trials are comparing different, new formulations of oral semaglutide, code-named C and D, to the existing product. All patients provided written informed consent before any trial-related activity. Patients who prematurely discontinued trial product remained in the trial and could receive any other antidiabetic medications at the investigator’s discretion (excluding GLP-1RAs in the oral semaglutide arm before completion of the follow-up visit 5 weeks after the last date on trial product). Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial.
Trial product estimand: Data collected after discontinuation of trial product or initiation of rescue medication are excluded.
and M.B.T. Expanding semglutide's reach could help bolster sales of the drug. on Subscribe to BioPharma Dive to get the must-read news & insights in your inbox. Visit GlobalData Store, Drug Processing Technology and Laboratory Equipment, Software, Consulting and Workshops for Data Analysis and Model-Based Decision Support, 24th September 2019 (Last Updated September 24th, 2019 14:59).
2. 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. Selected secondary end points (treatment policy estimand and trial product estimand)a. Fasting plasma glucose was reduced with both treatments, with no significant difference between groups (Table 2 and Supplementary Fig.
Baseline characteristics were well balanced between treatment groups (Table 1). Once-weekly injectable semaglutide is the follow-on product to Victoza and was approved in December for the treatment of type 2 diabetes under the brand name Ozempic. The treatment policy estimand was estimated by a pattern-mixture model using multiple imputation to handle missing week 26 data for both confirmatory end points. 1 and Table 2). were involved in the concept and design of the study. Both the imputation and the analysis were based on ANCOVA models. 8). S.Ø.L. For the three doses of oral semaglutide, the change from baseline was -0.3% for the 3mg dose, -0.7% for the 7mg dose, and -1.1% for the 14mg dose, with -0.4% for Januvia 100mg. Key exclusion criteria (see Supplementary Table 1 for full list) were any medication for diabetes or obesity within the previous 90 days other than metformin or short-term (≤14 days) insulin, renal impairment with an estimated glomerular filtration rate <60 mL/min/1.73 m2, proliferative retinopathy or maculopathy requiring acute treatment verified by fundus photography or dilated fundoscopy, and history of pancreatitis.
H.W.R.
Bodyweight change from baseline (88.8kg) was also recorded for the three doses as -1.7kg for the 3mg dose, -2.5kg for the 7mg dose, and -4.1kg for the 14mg dose, as well as -1.5kg for placebo. The free newsletter covering the top industry headlines, By signing up to receive our newsletter, you agree to our, Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire, The meeting that could change Alzheimer's treatment, Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval, Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma, In 2020 election, an uncertain fate for drug price controls, Bristol Myers bet pays off as psoriasis drug beats Amgen rival in study, Trends and developments in real-world evidence. J.R. reports scientific advisory boards and honoraria or consulting fees from Eli Lilly, Novo Nordisk, Sanofi, Janssen, Boehringer Ingelheim, and Intarcia and grants/research support from Merck, Pfizer, Sanofi, Novo Nordisk, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, AstraZeneca, Janssen, Genentech, Boehringer Ingelheim, Intarcia, and Lexicon.
Key end points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Thank you for your interest in spreading the word about Diabetes Care. In the current trial, diabetic retinopathy–related adverse events were more frequent with oral semaglutide compared with empagliflozin, although occurrence was low in both groups (3.4% vs. 1.2%). Novo will have to prove that its treatment is both safe and can help people lose a significant amount of weight. and E.M. are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. E.M. reports scientific advisory boards, consulting, lecturing, and/or research grants from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Grupo Ferrer Internacional S.A., Intarcia, Menarini, Janssen, Servier, Merck Sharp & Dohme, Novo Nordisk, and Novartis. Duality of Interest. This estimand reflects the intention-to-treat principle as defined in International Council on Harmonization (ICH) E9 (24).
The safety profile of oral semaglutide was consistent with previous trials (11–16). Acknowledgments.
Emisphere is acknowledged for providing a license to the Eligen Technology, the sodium N-(8-[2-hydroxylbenzoyl] amino) caprylate component of oral semaglutide. Proportions of patients achieving ≥5% or ≥10% weight loss are shown in Fig.
In the PIONEER 2 trial, which investigated oral semaglutide versus Jardiance 25mg, the change from baseline HbA1c (8.1%) to week 52 was recorded for both study arms as -1.3% for 14mg oral semaglutide and -0.8% for Jardiance 25mg. Results from sensitivity analyses supported the results of the confirmatory analysis (Supplementary Fig. All analyses were performed using SAS 9.4M2 statistical software.
In the Phase 2 trial, 83% of people getting semaglutide lost at least 5% of their body weight, compared to only 23% of those on placebo and 66% taking Saxenda (liraglutide).