Results from the PIONEER Program Trials: The First Oral GLP-1 Receptor

Name of Study: Oral Semaglutide — The PIONEER 6 Program Trial

Goal of Study: To test the effectiveness of the first orally-administered GLP-1, oral semaglutide, against placebo on cardiovascular health, particularly major adverse cardiovascular events (MACE) such as the first occurrence of cardiovascular death, non-fatal heart attacks and non-fatal stroke.

Study Methods: Over 3,100 people with type 2 diabetes at high risk of cardiovascular events were randomized to either receive the placebo or the drug, which is still awaiting U.S. Food and Drug Administration (FDA) approval.

Results: The results showed oral semaglutide doesn’t increase the risk of major adverse cardiovascular events. When compared to a placebo, the risk of the primary outcomes below show:

• Cardiovascular death: 15 events with oral semaglutide (0.9 percent) vs. 30 events (1.9 percent) with placebo.
• Non-fatal strokes: 12 events with oral semaglutide (0.8 percent) vs. 16 events (1.0 percent) with placebo.
• Non-fatal heart attacks: 37 events with oral semaglutide (2.3 percent) vs. 31 events (1.9 percent) with placebo.
  • This was determined as not being significantly different than placebo.