focus clinical trial semaglutide

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. All analyses were performed using SAS 9.4M2 statistical software.

Semaglutide is a human GLP-1 analog currently available as a once-weekly injection associated with reduced glycated hemoglobin (HbA1c), weight loss, and fewer cardiovascular events in type 2 diabetes (3–9). 6) and significantly reduced mean postprandial increments, as averaged for all meals (excluding the treatment policy estimand evaluation at week 26) (Table 2). 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). F: Observed proportions of patients achieving body weight reduction ≥5% at weeks 26 and 52. Yet obesity has traditionally been a tough market to crack. Further details on the use of estimands in this trial are provided in Supplementary Data, Estimands, with additional background provided by Aroda et al.

Editorial support was funded by the sponsor and provided by independent medical writers under the guidance of the authors. Assessed by the trial product estimand, oral semaglutide provided significant reductions in body weight at 52 weeks. The results were combined by use of Rubin’s rule (31). 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. Search terms included semaglutide, glucagon-like peptide 1 receptor agonist, GLP-1 receptor agonist, and type 2 diabetes. The proportion of subjects that achieved HbA1c of under 7.0% at 26 weeks was also recorded from baseline 8.0%, at 59% for the 3mg dose, 72% for the 7mg dose, 89% for the 14mg dose, and 34% for placebo. Short-term use (≤21 days) of antidiabetic medication (e.g., in connection with intercurrent illness) was not considered as additional antidiabetic medication (including rescue medication).

Reductions in body weight occurred with both treatments, but superiority of oral semaglutide versus empagliflozin could not be confirmed at week 26. Two different questions related to the efficacy objectives were addressed through the definition of two estimands: treatment policy and trial product. 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. Diabetic retinopathy–related adverse events were reported in 14 (3.4%) patients in the oral semaglutide group and in 5 (1.2%) in the empagliflozin group (in-trial period) (Supplementary Table 5). Many patients with type 2 diabetes fail to achieve or maintain adequate blood glucose control when treated with metformin monotherapy. This estimand reflects the intention-to-treat principle as defined in International Council on Harmonization (ICH) E9 (24). Through to week 52, 52 (12.7%) patients initiated additional antidiabetic medication in the oral semaglutide group; in 31 (7.5%) of these patients, it was rescue medication. 2. 6). This article contains Supplementary Data online at

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. whether semaglutide reduces MACE in overweight and obese people. I.L. An independent external event adjudication committee (EAC) performed masked validation of predefined adverse events, including deaths, selected cardiovascular events, acute pancreatitis, malignant neoplasms, acute kidney injury, and lactic acidosis. The trial product estimand was estimated by a mixed model for repeated measurements that used data collected before premature trial product discontinuation or initiation of rescue medication from all randomized patients. Glycemic control and body weight–related efficacy end points. Results from sensitivity analyses supported the results of the confirmatory analysis (Supplementary Fig.

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