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Study · Randomized controlled trial · n = 308 · 2018

11 results

Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.

Seino Y, Terauchi Y, Osonoi T, Yabe D, Abe N, Nishida T, Zacho J, Kaneko S

Diabetes, obesity & metabolism5 Oct 2017Cited by 97 (Europe PMC)

PMID28786547 (opens in a new tab)PMCIDPMC5813234 (opens in a new tab)DOI10.1111/dom.13082 (opens in a new tab)PepBankPUB-28786547
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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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, 74.8% on semaglutide 0.5 mg had treatment-emergent adverse events, against 66.0% on sitagliptin.

    In plain wordsIn Japanese adults with type 2 diabetes, more side effects were reported with semaglutide 0.5 mg (74.8%) than with sitagliptin (66.0%).

    Peptide
    Semaglutide
    Outcome
    IncreaseTreatment-emergent adverse events, 0.5 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    TEAE incidence
    74.8%
    semaglutide 0.5 mg
    TEAE incidence
    66%
    sitagliptin

    Source sentences

    Summary
    More TEAEs were reported in semaglutide- vs sitagliptin-treated participants (74.8%, 71.6% and 66.0% in the semaglutide 0.5 mg, semaglutide 1.0 mg and sitagliptin groups, respectively).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  2. 02HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, 71.6% on semaglutide 1.0 mg had treatment-emergent adverse events, against 66.0% on sitagliptin.

    In plain wordsIn Japanese adults with type 2 diabetes, more side effects were reported with semaglutide 1.0 mg (71.6%) than with sitagliptin (66.0%).

    Peptide
    Semaglutide
    Outcome
    IncreaseTreatment-emergent adverse events, 1.0 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    TEAE incidence
    71.6%
    semaglutide 1.0 mg
    TEAE incidence
    66%
    sitagliptin

    Source sentences

    Summary
    More TEAEs were reported in semaglutide- vs sitagliptin-treated participants (74.8%, 71.6% and 66.0% in the semaglutide 0.5 mg, semaglutide 1.0 mg and sitagliptin groups, respectively).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  3. 03HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, 2.9% on semaglutide 0.5 mg discontinued prematurely, the same rate as with sitagliptin.

    In plain wordsIn Japanese adults with type 2 diabetes, 2.9% stopped semaglutide 0.5 mg early, the same as with sitagliptin.

    Peptide
    Semaglutide
    Outcome
    No significant changePremature discontinuation, 0.5 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    Premature discontinuation
    2.9%
    semaglutide 0.5 mg and sitagliptin

    Source sentences

    Summary
    In total, 2.9% of participants in both the semaglutide 0.5 mg and the sitagliptin group prematurely discontinued treatment, compared with 14.7% in the semaglutide 1.0 mg group.
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  4. 04HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, 14.7% on semaglutide 1.0 mg discontinued prematurely, against 2.9% on sitagliptin.

    In plain wordsIn Japanese adults with type 2 diabetes, 14.7% stopped semaglutide 1.0 mg early, compared with 2.9% on sitagliptin.

    Peptide
    Semaglutide
    Outcome
    IncreasePremature discontinuation, 1.0 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    Premature discontinuation
    14.7%
    semaglutide 1.0 mg
    Premature discontinuation
    2.9%
    sitagliptin

    Source sentences

    Summary
    In total, 2.9% of participants in both the semaglutide 0.5 mg and the sitagliptin group prematurely discontinued treatment, compared with 14.7% in the semaglutide 1.0 mg group.
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  5. 05HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, most discontinuations in the semaglutide 0.5 and 1.0 mg groups were due to adverse events.

    In plain wordsIn Japanese adults with type 2 diabetes, most people who stopped semaglutide early did so because of side effects.

    Peptide
    Semaglutide
    Outcome
    Not applicableReasons for discontinuation
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 and 1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Source sentences

    Summary
    The majority of discontinuations in the semaglutide 0.5 and 1.0 mg groups were attributable to adverse events (AEs).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  6. 06HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, adverse events were mainly mild to moderate.

    In plain wordsIn Japanese adults with type 2 diabetes, most side effects of semaglutide or sitagliptin were mild to moderate.

    Peptide
    Semaglutide
    Outcome
    Not applicableSeverity of adverse events
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 and 1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Source sentences

    Summary
    AEs were mainly mild to moderate.
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, gastrointestinal adverse events were most frequent with semaglutide and became less frequent over time.

    In plain wordsIn Japanese adults with type 2 diabetes, stomach and gut side effects were most common with semaglutide and faded over time.

    Peptide
    Semaglutide
    Outcome
    DecreaseGastrointestinal adverse events over time
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5 and 1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal AEs, most frequently reported with semaglutide, diminished in frequency over time.
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, semaglutide 0.5 mg lowered HbA1c more than sitagliptin after 30 weeks.

    In plain wordsIn Japanese adults with type 2 diabetes, semaglutide 0.5 mg lowered HbA1c more than sitagliptin.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 30, 0.5 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    ETD vs sitagliptin
    −1.13%
    semaglutide 0.5 mg

    Source sentences

    Summary
    The mean glycated haemoglobin (HbA1c [baseline 8.1%]) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, vs 0.7% with sitagliptin (estimated treatment difference [ETD] vs sitagliptin -1.13%, 95% confidence interval [CI] -1.32; -0.94, and -1.44%, 95% CI -1.63; -1.24; both P < .0001).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  9. 09HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, semaglutide 1.0 mg lowered HbA1c more than sitagliptin after 30 weeks.

    In plain wordsIn Japanese adults with type 2 diabetes, semaglutide 1.0 mg lowered HbA1c more than sitagliptin.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 30, 1.0 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    ETD vs sitagliptin
    −1.44%
    semaglutide 1.0 mg

    Source sentences

    Summary
    The mean glycated haemoglobin (HbA1c [baseline 8.1%]) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, vs 0.7% with sitagliptin (estimated treatment difference [ETD] vs sitagliptin -1.13%, 95% confidence interval [CI] -1.32; -0.94, and -1.44%, 95% CI -1.63; -1.24; both P < .0001).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  10. 10HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, semaglutide 0.5 mg reduced body weight more than sitagliptin after 30 weeks.

    In plain wordsIn Japanese adults with type 2 diabetes, semaglutide 0.5 mg led to more weight loss than sitagliptin.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change at week 30, 0.5 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    ETD vs sitagliptin
    −2.22 kg
    semaglutide 0.5 mg

    Source sentences

    Summary
    Body weight (baseline 69.3 kg) was reduced by 2.2 and 3.9 kg with semaglutide 0.5 and 1.0 mg, respectively (ETD -2.22 kg, 95% CI -3.02; -1.42 and -3.88 kg, 95% CI -4.70; -3.07; both P < .0001).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…
  11. 11HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, semaglutide 1.0 mg reduced body weight more than sitagliptin after 30 weeks.

    In plain wordsIn Japanese adults with type 2 diabetes, semaglutide 1.0 mg led to more weight loss than sitagliptin.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change at week 30, 1.0 mg
    Study

    n = 308

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    ETD vs sitagliptin
    −3.88 kg
    semaglutide 1.0 mg

    Source sentences

    Summary
    Body weight (baseline 69.3 kg) was reduced by 2.2 and 3.9 kg with semaglutide 0.5 and 1.0 mg, respectively (ETD -2.22 kg, 95% CI -3.02; -1.42 and -3.88 kg, 95% CI -4.70; -3.07; both P < .0001).
    1 context sentence
    Summary · context
    In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-dail…

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 postedNCT02254291

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 3082 Oct 2014 to 11 Nov 2015

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 13 Sept 2018

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 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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