Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial.

Yamada Y, Katagiri H, Hamamoto Y, Deenadayalan S, Navarria A, Nishijima K, Seino Y

The lancet. Diabetes & endocrinology1 May 2020Cited by 170 (Europe PMC)

PMID32333875DOI10.1016/s2213-8587(20)30075-9PepBankPUB-32333875

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 3 mg lowered HbA1c more than placebo at week 26.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 3 mg lowered HbA1c more than placebo.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26 vs placebo, 3 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference vs placebo
−1.1 percentage points
oral semaglutide 3 mg
Source sentences
Summary
Estimated treatment differences for change in HbA_1c compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) f…
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387501
02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 7 mg lowered HbA1c more than placebo at week 26.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg lowered HbA1c more than placebo.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26 vs placebo, 7 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference vs placebo
−1.5 percentage points
oral semaglutide 7 mg
Source sentences
Summary
Estimated treatment differences for change in HbA_1c compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) f…
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387502
03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than placebo at week 26.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than placebo.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26 vs placebo, 14 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference vs placebo
−1.7 percentage points
oral semaglutide 14 mg
Source sentences
Summary
Estimated treatment differences for change in HbA_1c compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) f…
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387503
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, HbA1c fell from baseline to week 26 with oral semaglutide 3 mg.
In plain wordsIn Japanese adults with type 2 diabetes, HbA1c fell over 26 weeks with oral semaglutide 3 mg.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from baseline to week 26, 3 mg
Study
n = 49
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.1%
oral semaglutide 3 mg
Source sentences
Summary
Changes in HbA_1c from baseline (mean 8·2%) to week 26 were dose-dependent with oral semaglutide (mean change -1·1% [SE 0·1] for oral semaglutide 3 mg, -1·5% [0·1] for 7 mg, and -1·7% [0·1] for 14 mg), -0·1% (0·1) with placebo, and -1·4% (0·1) with liraglutide 0·9 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48).
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387507
05HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, HbA1c fell from baseline to week 26 with oral semaglutide 7 mg.
In plain wordsIn Japanese adults with type 2 diabetes, HbA1c fell over 26 weeks with oral semaglutide 7 mg.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from baseline to week 26, 7 mg
Study
n = 49
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.5%
oral semaglutide 7 mg
Source sentences
Summary
Changes in HbA_1c from baseline (mean 8·2%) to week 26 were dose-dependent with oral semaglutide (mean change -1·1% [SE 0·1] for oral semaglutide 3 mg, -1·5% [0·1] for 7 mg, and -1·7% [0·1] for 14 mg), -0·1% (0·1) with placebo, and -1·4% (0·1) with liraglutide 0·9 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48).
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387508
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, HbA1c fell from baseline to week 26 with oral semaglutide 14 mg.
In plain wordsIn Japanese adults with type 2 diabetes, HbA1c fell over 26 weeks with oral semaglutide 14 mg.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from baseline to week 26, 14 mg
Study
n = 48
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.7%
oral semaglutide 14 mg
Source sentences
Summary
Changes in HbA_1c from baseline (mean 8·2%) to week 26 were dose-dependent with oral semaglutide (mean change -1·1% [SE 0·1] for oral semaglutide 3 mg, -1·5% [0·1] for 7 mg, and -1·7% [0·1] for 14 mg), -0·1% (0·1) with placebo, and -1·4% (0·1) with liraglutide 0·9 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48).
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387509
07HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, HbA1c fell from baseline to week 26 with subcutaneous liraglutide 0.9 mg.
In plain wordsIn Japanese adults with type 2 diabetes, HbA1c fell over 26 weeks with liraglutide injections.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change from baseline to week 26
Study
n = 48
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−1.4%
liraglutide 0.9 mg
Source sentences
Summary
Changes in HbA_1c from baseline (mean 8·2%) to week 26 were dose-dependent with oral semaglutide (mean change -1·1% [SE 0·1] for oral semaglutide 3 mg, -1·5% [0·1] for 7 mg, and -1·7% [0·1] for 14 mg), -0·1% (0·1) with placebo, and -1·4% (0·1) with liraglutide 0·9 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48).
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387512
08HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 3 mg did not differ significantly from liraglutide in HbA1c change at week 26.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 3 mg and liraglutide did not differ clearly in HbA1c change.
Peptide
Semaglutide
Outcome
No significant changeHbA1c change at week 26 vs liraglutide, 3 mg
Study
n: not reported in source
Comparator
Liraglutide 0.9 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference vs liraglutide
0.3 percentage points
oral semaglutide 3 mg
Source sentences
Summary
Estimated treatment differences for change in HbA_1c compared with liraglutide 0·9 mg were 0·3 percentage points (95% CI -0·0 to 0·6; p=0·0799) for oral semaglutide 3 mg, -0·1 percentage points (-0·4 to 0·2; p=0·3942) for oral semaglutide 7 mg, and -0·3 percentage points (-0·6 to -0·0; p=0…
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387504
09HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 7 mg did not differ significantly from liraglutide in HbA1c change at week 26.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg and liraglutide did not differ clearly in HbA1c change.
Peptide
Semaglutide
Outcome
No significant changeHbA1c change at week 26 vs liraglutide, 7 mg
Study
n: not reported in source
Comparator
Liraglutide 0.9 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference vs liraglutide
−0.1 percentage points
oral semaglutide 7 mg
Source sentences
Summary
Estimated treatment differences for change in HbA_1c compared with liraglutide 0·9 mg were 0·3 percentage points (95% CI -0·0 to 0·6; p=0·0799) for oral semaglutide 3 mg, -0·1 percentage points (-0·4 to 0·2; p=0·3942) for oral semaglutide 7 mg, and -0·3 percentage points (-0·6 to -0·0; p=0…
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387505
10HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than liraglutide at week 26.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than liraglutide.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26 vs liraglutide, 14 mg
Study
n: not reported in source
Comparator
Liraglutide 0.9 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference vs liraglutide
−0.3 percentage points
oral semaglutide 14 mg
Source sentences
Summary
Estimated treatment differences for change in HbA_1c compared with liraglutide 0·9 mg were 0·3 percentage points (95% CI -0·0 to 0·6; p=0·0799) for oral semaglutide 3 mg, -0·1 percentage points (-0·4 to 0·2; p=0·3942) for oral semaglutide 7 mg, and -0·3 percentage points (-0·6 to -0·0; p=0…
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387506
11HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, constipation occurred in 10-13% of patients on oral semaglutide and 6% on placebo.
In plain wordsIn Japanese adults with type 2 diabetes, constipation affected 10-13% of patients on oral semaglutide and 6% on placebo.
Peptide
Semaglutide
Outcome
Direction not reportedConstipation
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3, 7 or 14 mg once daily · oralAs given in this study (human).
Measurements
Constipation incidence
10 to 13%
oral semaglutide
Source sentences
Summary
constipation was most common, occurring in five to six (10-13%) patients with oral semaglutide, three (6%) with placebo
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387510
12HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, gastrointestinal events, mostly mild or moderate, were the most frequent class of adverse event with oral semaglutide.
In plain wordsIn Japanese adults with type 2 diabetes, stomach and gut side effects, mostly mild or moderate, were the most common side effects of oral semaglutide.
Peptide
Semaglutide
Outcome
Direction not reportedGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3, 7 or 14 mg once daily · oralAs given in this study (human).
Source sentences
Summary
Gastrointestinal events, predominantly of mild or moderate severity, were the most frequently reported class of adverse event with oral semaglutide
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387511
13HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, constipation occurred in 19% of patients on liraglutide.
In plain wordsIn Japanese adults with type 2 diabetes, constipation affected 19% of patients on liraglutide.
Peptide
Liraglutide
Outcome
Direction not reportedConstipation
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.9 mg · subcutaneousAs given in this study (human).
Measurements
Constipation incidence
19%
liraglutide 0.9 mg
Source sentences
Summary
constipation was most common, occurring in five to six (10-13%) patients with oral semaglutide, three (6%) with placebo, and nine (19%) with liraglutide 0·9 mg.
1 context sentence(design, population, supporting numbers)
Summary · context
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.
Report a problemFND-3233387513

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03018028

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 24310 Jan 2017 to 15 Aug 2018

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 15 Jan 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
12 Oct 2026, 11:11 UTC
Study results updated
Version 2
9 Oct 2026, 03:06 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC