Listing a study does not mean it has been evaluated by the U.S. Federal Government. The MACE composite had a hazard ratio (HR) of .79 in favor of oral semaglutide, reaching non-inferiority. 4 A dedicated ophthalmic trial (FOCUS) of 5 years treatment duration will assess the long-term effect of semaglutide on diabetic retinopathy development and progression. 31 Patients were randomized to oral semaglutide 3 mg, 7 mg, or 14 mg or dulaglutide 0.75 mg. Gastrointestinal adverse events were more common with oral semaglutide. Oral Semaglutide and Cardiovascular Outcomes in Diabetes Safety data exist for subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, but not for the oral form. Despite patients with proliferative diabetic retinopathy being excluded from PIONEER 6, a 0.8% increase in diabetic retinopathy was observed with oral semaglutide. PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes. Superior weight loss was not confirmed at week 26 (treatment policy), but oral semaglutide was significantly better than empagliflozin at week 52 (trial product -4.7 vs. -3.8 kg; P = 0.0114). A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Oral semaglutide 14 mg had a statistically significant reduction in A1C compared to dulaglutide at 52 weeks (−1.8% vs. −1.3%). In the double-blind PIONEER 4 trial, which was simultaneously published in The Lancet, patients were randomly assigned to receive oral semaglutide 14 mg once daily (n=285), subcutaneous liraglutide 1.8 mg (n=284), or placebo (n=142) for 52 weeks. PIONEER 10 was a randomized, open label trial in 44 Japanese patients with uncontrolled T2D on one oral antidiabetic agent. 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. This article reports the findings of the Peptide Innovation for Early Diabetes Treatment 8 (PIONEER 8) trial, which investigated the efficacy, safety, and tolerability of oral semaglutide added onto insulin (basal, basal-bolus, or premixed) with or without metformin in patients with uncontrolled type 2 diabetes. Aroda VR(1)(2), Rosenstock J(3), Terauchi Y(4), Altuntas Y(5), Lalic NM(6), Morales Villegas EC(7), Jeppesen OK(8), Christiansen E(8), Hertz CL(8), Haluzík M; PIONEER 1 Investigators. medwireNews: Oral semaglutide offers greater efficacy for glucose control and weight loss when compared with sitagliptin for people with type 2 diabetes, although with more adverse events at the highest dose, show the PIONEER 3 findings.