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Study · Randomized controlled trial · 2021

10 results

Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials.

Araki E, Terauchi Y, Watada H, Deenadayalan S, Christiansen E, Horio H, Kadowaki T

Diabetes, obesity & metabolism27 Sept 2021Cited by 9 (Europe PMC)

PMID34472698 (opens in a new tab)PMCIDPMC9293331 (opens in a new tab)DOI10.1111/dom.14536 (opens in a new tab)PepBankPUB-34472698
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, oral semaglutide 7 mg reduced HbA1c from baseline by 1.0% to 1.2% across the PIONEER 1, 3, 4 and 8 subgroups.

    In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg lowered HbA1c by 1.0% to 1.2%.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c reduction from baseline at week 26
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    7 mg · oral · 26 weeksAs given in this study (human).

    Measurements

    HbA1c reduction
    1 to 1.2%
    oral semaglutide 7 mg

    Source sentences

    Summary
    Reductions in HbA1c from baseline in Japanese patients were 1.0% to 1.2% (11.3 mmol/mol to 13.3 mmol/mol) and 1.4% to 1.7% (15.7 mmol/mol to 18.3 mmol/mol) for oral semaglutide 7 mg and 14 mg, respectively.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, oral semaglutide 14 mg reduced HbA1c from baseline by 1.4% to 1.7% across the PIONEER 1, 3, 4 and 8 subgroups.

    In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c by 1.4% to 1.7%.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c reduction from baseline at week 26
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    14 mg · oral · 26 weeksAs given in this study (human).

    Measurements

    HbA1c reduction
    1.4 to 1.7%
    oral semaglutide 14 mg

    Source sentences

    Summary
    Reductions in HbA1c from baseline in Japanese patients were 1.0% to 1.2% (11.3 mmol/mol to 13.3 mmol/mol) and 1.4% to 1.7% (15.7 mmol/mol to 18.3 mmol/mol) for oral semaglutide 7 mg and 14 mg, respectively.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, HbA1c reductions with oral semaglutide were similar to or greater than those with the comparators.

    In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide lowered HbA1c about as much as, or more than, the comparator treatments.

    Peptide
    Semaglutide
    Outcome
    MixedHbA1c reduction versus comparators
    Study

    n: not reported in source

    Comparator
    Placebo, sitagliptin 100 mg or liraglutide 1.8 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    7 mg and 14 mg · oral · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    HbA1c reductions were similar or greater than with comparators.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, oral semaglutide 7 mg reduced body weight by 1.0% to 2.7%.

    In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg reduced body weight by 1.0% to 2.7%.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight reduction at week 26
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7 mg · oral · 26 weeksAs given in this study (human).

    Measurements

    Body weight reduction
    1 to 2.7%
    oral semaglutide 7 mg

    Source sentences

    Summary
    Body weight reductions were 1.0% to 2.7% and 3.7% to 4.7% for oral semaglutide 7 mg and 14 mg, respectively, and were generally greater with oral semaglutide than comparators.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, oral semaglutide 14 mg reduced body weight by 3.7% to 4.7%.

    In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg reduced body weight by 3.7% to 4.7%.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight reduction at week 26
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    14 mg · oral · 26 weeksAs given in this study (human).

    Measurements

    Body weight reduction
    3.7 to 4.7%
    oral semaglutide 14 mg

    Source sentences

    Summary
    Body weight reductions were 1.0% to 2.7% and 3.7% to 4.7% for oral semaglutide 7 mg and 14 mg, respectively, and were generally greater with oral semaglutide than comparators.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, body weight reductions were generally greater with oral semaglutide than with the comparators.

    In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide generally reduced body weight more than the comparator treatments.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight reduction versus comparators
    Study

    n: not reported in source

    Comparator
    Placebo, sitagliptin 100 mg or liraglutide 1.8 mg
    Analysis
    Exploratory
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7 mg and 14 mg · oral · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Body weight reductions were 1.0% to 2.7% and 3.7% to 4.7% for oral semaglutide 7 mg and 14 mg, respectively, and were generally greater with oral semaglutide than comparators.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, the main class of adverse events with oral semaglutide was gastrointestinal.

    In plain wordsIn Japanese adults with type 2 diabetes taking oral semaglutide, most side effects affected the stomach and gut.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    As expected, the main class of AEs was gastrointestinal, and these AEs comprised most commonly mild-to-moderate constipation, nausea and diarrhoea.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  8. 08HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, constipation was among the most common mild-to-moderate gastrointestinal adverse events with oral semaglutide.

    In plain wordsIn Japanese adults with type 2 diabetes taking oral semaglutide, constipation was one of the most common mild-to-moderate side effects.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedConstipation
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    As expected, the main class of AEs was gastrointestinal, and these AEs comprised most commonly mild-to-moderate constipation, nausea and diarrhoea.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  9. 09HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, nausea was among the most common mild-to-moderate gastrointestinal adverse events with oral semaglutide.

    In plain wordsIn Japanese adults with type 2 diabetes taking oral semaglutide, nausea was one of the most common mild-to-moderate side effects.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedNausea
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    As expected, the main class of AEs was gastrointestinal, and these AEs comprised most commonly mild-to-moderate constipation, nausea and diarrhoea.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).
  10. 10HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, diarrhoea was among the most common mild-to-moderate gastrointestinal adverse events with oral semaglutide.

    In plain wordsIn Japanese adults with type 2 diabetes taking oral semaglutide, diarrhoea was one of the most common mild-to-moderate side effects.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedDiarrhoea
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    As expected, the main class of AEs was gastrointestinal, and these AEs comprised most commonly mild-to-moderate constipation, nausea and diarrhoea.
    1 context sentence
    Summary · context
    Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg).

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

Registered trials3

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

3 trials · 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02906930

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

Novo Nordisk A/Sn = 70320 Sept 2016 to 8 Dec 2017

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 20 Jul 2022
CompletedPhase 3Results postedNCT02863419

Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/Sn = 71110 Aug 2016 to 30 Mar 2018

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 20 Jul 2022
CompletedPhase 3Results postedNCT02607865

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 1,86415 Feb 2016 to 28 Mar 2018

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 20 Jul 2022

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.

  1. Version 3Current

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:06 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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