They call for more research into flexible dosing regimens using both higher and lower doses than used in this study, to further reduce discontinuations and make use of even higher doses in patients who can tolerate them, noting that these are already used to treat obesity. PIONEER 4: Published. However, the reduction of MACE with oral semaglutide did not reach statistical significance. All rights reserved. “[T]he one-size-fits-all approach that has been used traditionally in the [glucagon-like peptide-1] receptor agonist field could now be challenged,” they conclude. Nine percent of patients discontinued semaglutide because of adverse events, compared with 3% who discontinued sitagliptin. Semaglutide-treated patients achieved average HbA1c levels that were a significant 0.5 percentage points lower than those achieved by the sitagliptin group, and the treatment difference for bodyweight was an average 1.9 kg in favor of semaglutide treatment. Total daily insulin dose was reduced by an optional 20% and capped at baseline (BL) level for week 0-26 and freely adjustable for week 26-52. Participants were either ≥50 years of age with cardiovascular disease, or ≥60 years of age with at least 1 cardiovascular risk factor. During 26 weeks of treatment, those taking oral semaglutide (dose escalated to 14 mg/day) had a significant 1.0 percentage point reduction in glycated hemoglobin (HbA1c), which was significantly greater than the 0.2 percentage point reduction seen in those taking placebo. The double-blinded phase 3a trial included 3138 participants with type 2 diabetes at high risk for cardiovascular events who were randomized to receive oral semaglutide 14 mg once daily or placebo, both in addition to standard of care. There are roughly 30 million Americans diagnosed with diabetes mellitus (DM), with nearly 95% of these cases being type 2 (T2)-DM. All rights reserved. In patients with atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease, adding a glucagon-like peptide 1 receptor agonist is a preferred treatment option; however, many patients are apprehensive about injecting medications. PIONEER 5: Published. The purpose of this article was to review the pharmacology, clinical trials, safety profile, along with recommended dosing and costs, of oral semaglutide used for managing patients with T2DM. Both trials were presented this week at the 79th ADA Scientific Sessions in San Francisco, California, USA, with simultaneous publication in The Lancet Diabetes & Endocrinology. US Food and Drug Administration (FDA) approved an injectable form of semaglutide. "Based on the strong clinical data reported throughout the PIONEER clinical trial program, we have now established a solid efficacy and safety profile for oral semaglutide and we are looking forward to sharing the results with regulatory authorities during 2019.". Both trials were presented this week at the 79th ADA Scientific Sessions in San Francisco, California, USA, with simultaneous publication in The Lancet Diabetes & Endocrinology. Two formulations of semaglutide have been approved by the FDA; semaglutide for subcutaneous injection once-weekly (marketed as Ozempic®) 1 and semaglutide for oral administration once-daily (marketed as Rybelsus®). PIONEER 7, from Thomas Pieber (Medical University of Graz, Austria) and colleagues, is similar to the previously published PIONEER 3, testing three doses of oral semaglutide against the dipeptidyl peptidase-4 inhibitor sitagliptin. "We are very encouraged that PIONEER 6 demonstrated cardiovascular safety as well as a significant reduction in both CV and all-cause mortality following oral semaglutide treatment in people with type 2 diabetes at high cardiovascular risk," said Mads Krogsgaard Thomsen, PhD, DSc, executive vice president and chief science officer of Novo Nordisk, in a statement. © 2020 MJH Life Sciences™ and HCPLive. © 2019 Springer Healthcare part of the Springer Nature group, Lancet Diabetes Endocrinol 2019; doi:10.1016/S2213-8587(19)30192-5 (PIONEER 5)Lancet Diabetes Endocrinol 2019; doi:10.1016/S2213-8587(19)30194-9 (PIONEER 7)Lancet Diabetes Endocrinol 2019; doi:10.1016/S2213-8587(19)30182-2 (commentary)79th ADA Scientific Sessions; San Francisco, California, USA: 7–11 June 2019. The PIONEER trial series has shown this medication to significantly reduce HbA 1c and body weight in comparison to some other commonly used antihyperglycemic agents, including other GLP-1RA therapies. PIONEER 1: Published. “Interestingly, most of [the] side-effects and drug discontinuations occurred in the first 8 weeks, when all participants randomly assigned to oral semaglutide took 3 mg per day per protocol,” say Nauck and Meier. Semaglutide is a potent glucagon-like peptide 1 (GLP-1) analogue with a high degree of homology to human GLP-1. On review of the literature, it appeared that semaglutide is a viable option in treating T2DM. Three Phase II studies of the pharmacokinetic properties and Phase III trials from the PIONEER series were ultimately selected, as these trials were thought to provide pivotal information to the US Food and Drug Administration for the approval of oral semaglutide. PIONEER 3: Published. Trial population: Medication-naïve people with type 2 diabetes. The PIONEER 6 primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. As reported in Diabetes Care, 703 ... PIONEER 2: Published. The American Diabetes Association continues to recommend metformin as the first-line initial treatment of T2DM, in combination with lifestyle modifications; yet, many require multiple therapies to achieve adequate glycemic control. Data about the study’s secondary outcome measures was not included in the company’s press release. Copyright © 2020 Springer Healthcare Limited. In 2017, the US Food and Drug Administration (FDA) approved an injectable form of semaglutide for use as a supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes. In a linked commentary, Michael Nauck and Juris Meier, both from Ruhr-University Bochum in Germany, say: “Given the suitability of only a few classes of oral glucose-lowering drugs for the treatment of type 2 diabetes in those with chronic kidney disease, this study is highly relevant and helpful for a relatively large subpopulation of patients with both type 2 diabetes and chronic kidney disease.”. Topline data shows that the diabetes medication is non-inferior to placebo with regard to a composite outcome of major adverse cardiovascular events. We use cookies to help provide and enhance our service and tailor content and ads.

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