Summary of PIONEER results28 30–38
Trial (n) | Background regimen† | Doses and comparators | Body weight change from baseline (kg) | Patients with weight loss of>5% (%) |
PIONEER 1 (n=703)23 | Diet and Exercise | Oral semaglutide 3 mg | –1.5 | 20 |
Oral semaglutide 7 mg | –2.3 | 27 | ||
Oral semaglutide 14 mg | –3.7* | 40* | ||
Placebo | –1.4 | 15 | ||
PIONEER 2 (n=822)20 | Metformin | Oral semaglutide 14 mg | –3.8 | 41 |
Empagliflozin 25 mg | –3.7 | 36 | ||
PIONEER 3 (n=1864)22 | Metformin, Sulfonylurea | Oral semaglutide 3 mg | –1.2 | 13 |
Oral semaglutide 7 mg | –2.2* | 19* | ||
Oral semaglutide 14 mg | –3.1* | 30* | ||
Sitagliptin 100 mg | –0.6 | 10 | ||
PIONEER 4 (n=711)25 | Metformin, SGLT-2 inhibitor | Oral semaglutide 14 mg | –4.4* | 44* |
Liraglutide 1.8 mg | –3.1 | 28 | ||
Placebo | –0.5 | 8 | ||
PIONEER 5 (n=324)24 | Metformin, Basal insulin, Sulfonylurea | Oral semaglutide 14 mg | –3.4* | 36* |
Placebo | –0.9 | 10 | ||
PIONEER 6 (n=3183)30 | No exclusion based on regimen | Oral semaglutide 14 mg | –4.2 | NR |
Placebo | –0.8 | |||
PIONEER 7 (n=504)28 | 1–2 antihyperglycemic agents | Oral semaglutide (flexible dose 3, 7, or 14 mg) | –2.6* | 27* |
Sitagliptin 100 mg | –0.7 | 12 | ||
PIONEER 8 (n=731)27 | Metformin, insulin (basal, basal-bolus, or premixed) | Oral semaglutide 3 mg | –1.4* | 13* |
Oral semaglutide 7 mg | –2.4* | 31* | ||
Oral semaglutide 14 mg | –3.7* | 39* | ||
Placebo | –0.4 | 3 | ||
PIONEER 9 (n=243)26 | Diet and exercise or one antihyperglycemic agent | Oral semaglutide 3 mg | –0.6 | 4 |
Oral semaglutide 7 mg | –1.1* | 10 | ||
Oral semaglutide 14 mg | –2.4* | 34* | ||
Liraglutide 0.9 mg | 0.0 | 0 | ||
Placebo | –1.1 | 10 | ||
PIONEER 10 (n=458)29 | one antihyperglycemic agent | Oral semaglutide 3 mg | –0.2 | 5 |
Oral semaglutide 7 mg | –1.0* | 18* | ||
Oral semaglutide 14 mg | –2.2* | 31* | ||
Dulaglutide 0.75 mg | –0.3 | 6 |
PIONEER (Peptide Innovation for Early Diabetes Treatment) SGLT-2 inhibitor (Sodium Glucose Cotransporter 2 Inhibitors)
*P<0.05 indicating the superiority of semaglutide versus the respective comparator.
†Alone or in combination with one another.
NR, not recorded.