Oral Semaglutide Demonstrates Efficacy Across All Baseline HbA1c Levels in Patients with Type 2 Diabetes
Sep 18, 2019 11:08
CST Updated
11:08
Novo Nordisk
Insulin Developer and Manufacturer
September 18, 2019 /BioonBIOON/ --DiabetesNovo Nordisk recently announced the results of an exploratory analysis from its PIONEER IIIa clinical program, showing that oral semaglutide (3, 7, and 14 mg) across various baseline blood glucose levels in type 2DiabetesImproved glycemic control was observed in patients. Compared with all control groups, semaglutide at doses of 7 mg and 14 mg significantly reduced HbA1c levels. The control groups included: placebo, the SGLT2 inhibitor Jardiance (empagliflozin, 25 mg), the DPP-4 inhibitor Januvia (sitagliptin, 100 mg), and the GLP-1 analog Victoza (liraglutide, 1.8 mg).
This result was presented at the recent EuropeanDiabetespresented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD). Oral semaglutide is a once-daily glucagon-like peptide-1 (GLP-1) analog.
The PIONEER IIIa Phase Clinical Project is a global development project, in 10 itemsClinical TrialsA total of 9,543 patients with type 2 diabetes were enrolled.DiabetesPatient.In this analysis, a total of 5,657 patients from the PIONEER 1–5, 7, and 8 trials were stratified by baseline HbA1c levels (≤8.0%, >8.0%–≤9.0%, and >9.0%). Across all trials and all baseline HbA1c subgroups, the proportion of patients with type 2 diabetes achieving an HbA1c <7% was higher with oral semaglutide 7 mg and 14 mg than with the control treatments. The safety profile of oral semaglutide in the PIONEER program was consistent with that of the GLP-1 receptor agonist class and similar to that of subcutaneous semaglutide.
Dr. Juris Meier, Professor of Medicine and Director of the Department of Diabetes and Gastrointestinal Endocrinology at St. Josef Hospital, Ruhr University Bochum, Germany, stated: “Patients with type 2 diabetes have individualized treatment goals related to glycemic control. The results of this analysis are particularly significant because they demonstrate that oral semaglutide can improve glycemic control in patients with type 2 diabetes across various baseline glycemic levels.”
Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk, stated: “This analysis reinforces the findings of the PIONEER program, demonstrating the efficacy of oral semaglutide in lowering HbA1c compared with commonly used treatments for type 2 diabetes. If approved, oral semaglutide would become the first and only oral GLP-1 receptor agonist, potentially helping patients with type 2 diabetes whose blood glucose levels are uncontrolled to achieve better disease management.”
Semaglutide is a novel long-acting glucagon-like peptide-1 (GLP-1) receptor agonist that promotes insulin secretion and suppresses glucagon secretion in a glucose concentration-dependent manner, significantly improving glycemic control in patients with type 2 diabetes while carrying a low risk of hypoglycemia. Additionally, semaglutide can induceWeight LossIn addition, semaglutide can significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.
In early December 2017, the once-weekly subcutaneous injection formulation of semaglutide was approved in the United StatesFDAApproved for marketing under the brand name Ozempic. Currently, Novo Nordisk is also developing an oral formulation of semaglutide, a once-daily tablet containing the absorption-enhancing excipient SNAC.
According to the pharmaceutical market research firm EvaluatePharma, as the world’s first oral GLP-1 receptor agonist, oral semaglutide has very promising commercial prospects, with projected sales reaching $2.23 billion in 2024. Semaglutide is thus hailed as the best GLP-1 agonist globally, and in 2024, the combined sales of its oral and subcutaneous injection formulations will surpassEli Lillyof the GLP-1 receptor agonist Trulicity, which is also currently the best-selling drug in the GLP-1 class, with sales reaching $2.516 billion in 2018 and projected to reach $5.35 billion in 2024. (Bioon.com)