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Table 1 Summary of design and primary endpoints across the PIONEER trials considering trial product without rescue medication (trial product estimand)

From: Advances in GLP-1 treatment: focus on oral semaglutide

Trial Populationa Primary endpoint Treatment Results primary endpoint (%) EDT (95% CI) p
PIONEER 1 703 adults with T2D uncontrolled with diet and exercise Change in HbA1c from baseline to week 26 Sema 3 mg − 0.8 − 0.7% (− 0.9 to − 0.5) < 0.001
Sema 7 mg − 1.3 − 1.2% (− 1.5 to − 1.0) < 0.001
Sema 14 mg − 1.5 − 1.4% (− 1.7 to − 1.2) < 0.001
Pbo − 0.1
PIONEER 2 822 adults with T2D uncontrolled on metformin Change in HbA1c from baseline to week 26 Sema 14 mg − 1.4 − 0.5% (− 0.7 to − 0.4) < 0.0001
Empa 25 mg − 0.9
PIONEER 3 1864 adults with T2D uncontrolled with metformin and/or sulfonylurea Change in HbA1c from baseline to week 26 Sema 3 mg − 0.5 0.2% (0.1–0.4) < 0.001
Sema 7 mg − 1.1 − 0.3% (− 0.4 to − 0.2) < 0.001
Sema 14 mg − 1.4 − 0.6% (− 0.7 to − 0.5) < 0.001
Sita 100 mg − 0.8
PIONEER 4 711 adults with T2D on metformin with or without an SGLT2 inhibitor Change in HbA1c from baseline to week 26 Sema 14 mg − 1.3 − 0.2% (− 0.3 to − 0.1)b 0.0056b
− 1.2% (− 1.4 to − 1.0)c < 0.001c
Lira 1.8 mg − 1.1
Pbo − 0.1
PIONEER 5 324 adults with T2D and moderate renal impairment on metformin and/or sulfonylurea, or basal insulin Change in HbA1c from baseline to week 26 Sema 14 mg − 1.1 1.0% (− 1.2 to − 0.8) < 0.0001
Pbo − 0.1
PIONEER 7 504 adults with T2D inadequately controlled on one of two oral glucose-lowering drugs Proportion of patients with HbA1c less than 7.0% at week 52 Sema flex 63 < 0.0001
Sita 100 mg 28
PIONEER 8 731 adults with T2D under insulin therapy with or without metformin Change in HbA1c from baseline to week 26 Sema 3 mg − 0.6 − 0.6 (− 0.7 to − 0.4) < 0.0001
Sema 7 mg − 1.0 − 1.0 (− 1.2 to − 0.8) < 0.0001
Sema 14 mg − 1.4 − 1.4 (− 1.6 to − 1.2) < 0.0001
Pbo − 0.0
  1. CI confidence interval; Dula dulaglutide; EDT estimated treatment differences; Empa empagliflozin; Flex flexible dose (3, 7 or 14 mg); Lira liraglutide; Pbo placebo; Sema oral semaglutide; Sita sitagliptin; T2D type 2 diabetes
  2. aRandomized
  3. bVersus liraglutide
  4. cVersus placebo