Semaglutide PIONEER Trials

Novo Nordisk designed the ten trial Phase III PIONEER program to support the NDA for oral semaglutide for the treatment of type 2 diabetes. If approved, semaglutide will be the first oral GLP-1 receptor agonist and will likely become a preferred treatment to add to patients that are inadequately controlled with metformin. There are links to seven published studies in the Pharmaceutical Pipeline Tracker.
 
Following are summaries of what we know about the ten trials.

• PIONEER -1: lowered HbA1c 1.1% more than placebo. 
• PIONEER -2*: lowered HbA1c 1.3% compared to 0.8% with empagliflozin in patients inadequately controlled on metformin. 
• PIONEER -3: lowered HbA1c 0.5% and decreased weight 1.6kg to 2.5kg more than sitagliptin in patients inadequately controlled on metformin with or without a sulfonylurea. 
• PIONEER -4: lowered HbA1c 1.2% compared to a 1.1% reduction with liraglutid. 
• PIONEER -5: lowered HbA1c 1.0% and lost 3.4 kg compared to a HbA1c decrease of 0.2% and 0.9 kg loss with placebo in patients with moderate renal impairment. 
• PIONEER-6: non-inferior to placebo in the occurrence of a combined endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke compared to placebo (3.8% occurrence vs 4.8%) when added to standard care in patients with type 2 diabetes. 
• PIONEER -7: 58% achieved an HbA1c < 7% compared to 25% with sitagliptin.
• PIONEER -8: lowered HbA1c 1.2% and a weight loss of 4.3 kg compared to no improvement in HbA1c and a 0.6 kg weight gain with placebo. 
• PIONEER -9*:  lowered HbA1c compared to a 1.4% reduction with liraglutide in Japanese patients. 
• PIONEER -10*: lowered HbA1c 1.8% and a weight loss of 1.9 kg compared to a 1.3% HbA1c reduction and a 1.1 kg weight gain with dulaglutide in Japanese patients.
  

* Results have been announced, but not published