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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