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Study · Randomized controlled trial · n = 601 · 2018

8 results

Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.

Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A

Diabetes, obesity & metabolism21 Feb 2018Cited by 106 (Europe PMC)

PMID29322610 (opens in a new tab)PMCIDPMC5969242 (opens in a new tab)DOI10.1111/dom.13218 (opens in a new tab)PepBankPUB-29322610
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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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, adverse events were reported more often with semaglutide 0.5 mg than with an additional oral antidiabetic drug.

    In plain wordsIn Japanese adults with type 2 diabetes, more people on semaglutide 0.5 mg reported side effects than on an added oral drug.

    Peptide
    Semaglutide
    Outcome
    IncreaseAdverse events after 56 weeks
    Study

    n = 601

    Comparator
    Additional oral antidiabetic drug
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Adverse events
    86.2%
    semaglutide 0.5 mg
    Adverse events
    71.7%
    additional OAD

    Source sentences

    Summary
    More AEs were reported in the semaglutide 0.5 mg (86.2%) and 1.0 mg (88.0%) groups than in the additional OAD group (71.7%).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  2. 02HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, adverse events were reported more often with semaglutide 1.0 mg than with an additional oral antidiabetic drug.

    In plain wordsIn Japanese adults with type 2 diabetes, more people on semaglutide 1.0 mg reported side effects than on an added oral drug.

    Peptide
    Semaglutide
    Outcome
    IncreaseAdverse events after 56 weeks
    Study

    n = 601

    Comparator
    Additional oral antidiabetic drug
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Adverse events
    88%
    semaglutide 1.0 mg
    Adverse events
    71.7%
    additional OAD

    Source sentences

    Summary
    More AEs were reported in the semaglutide 0.5 mg (86.2%) and 1.0 mg (88.0%) groups than in the additional OAD group (71.7%).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  3. 03HumanRandomized controlled trialSafety outcome

    Gastrointestinal adverse events were the most frequent adverse events with semaglutide and diminished over time.

    In plain wordsStomach and gut side effects were the most frequent with semaglutide, and they became less over time.

    Peptide
    Semaglutide
    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n = 601

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5 or 1.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal AEs were most frequent with semaglutide, which diminished over time.
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, semaglutide 0.5 mg lowered HbA1c more than an additional oral antidiabetic drug.

    In plain wordsSemaglutide 0.5 mg lowered HbA1c more than an added oral diabetes drug in Japanese adults with type 2 diabetes.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 56
    Study

    n = 601

    Comparator
    Additional oral antidiabetic drug
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.5 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.7%
    semaglutide 0.5 mg
    HbA1c change
    −0.7%
    additional OAD
    Estimated treatment difference
    −1.08%
    vs additional OAD

    Source sentences

    Summary
    The mean glycated haemoglobin (HbA1c) concentration (baseline 8.1%) was significantly reduced with semaglutide 0.5 mg and 1.0 mg vs additional OAD (1.7% and 2.0% vs 0.7%, respectively; estimated treatment difference [ETD] vs additional OAD -1.08% and -1.37%, both P < .0001).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, semaglutide 1.0 mg lowered HbA1c more than an additional oral antidiabetic drug.

    In plain wordsSemaglutide 1.0 mg lowered HbA1c more than an added oral diabetes drug in Japanese adults with type 2 diabetes.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 56
    Study

    n = 601

    Comparator
    Additional oral antidiabetic drug
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −2%
    semaglutide 1.0 mg
    HbA1c change
    −0.7%
    additional OAD
    Estimated treatment difference
    −1.37%
    vs additional OAD

    Source sentences

    Summary
    The mean glycated haemoglobin (HbA1c) concentration (baseline 8.1%) was significantly reduced with semaglutide 0.5 mg and 1.0 mg vs additional OAD (1.7% and 2.0% vs 0.7%, respectively; estimated treatment difference [ETD] vs additional OAD -1.08% and -1.37%, both P < .0001).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  6. 06HumanRandomized controlled trialEfficacy outcome

    Semaglutide 0.5 mg reduced body weight, whereas body weight rose with an additional oral antidiabetic drug.

    In plain wordsWeight fell with semaglutide 0.5 mg and rose slightly with an added oral drug.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change at week 56
    Study

    n = 601

    Comparator
    Additional oral antidiabetic drug
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.5 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Body weight change
    −1.4 kg
    semaglutide 0.5 mg
    Body weight change
    0.4 kg
    additional OAD
    Estimated treatment difference
    −1.84 kg
    vs additional OAD

    Source sentences

    Summary
    Body weight (baseline 71.5 kg) was reduced by 1.4 kg and 3.2 kg with semaglutide 0.5 mg and 1.0 mg, vs a 0.4-kg increase with additional OAD (ETD -1.84 kg and -3.59 kg; both P < .0001).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  7. 07HumanRandomized controlled trialEfficacy outcome

    Semaglutide 1.0 mg reduced body weight, whereas body weight rose with an additional oral antidiabetic drug.

    In plain wordsWeight fell with semaglutide 1.0 mg and rose slightly with an added oral drug.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change at week 56
    Study

    n = 601

    Comparator
    Additional oral antidiabetic drug
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Body weight change
    −3.2 kg
    semaglutide 1.0 mg
    Body weight change
    0.4 kg
    additional OAD
    Estimated treatment difference
    −3.59 kg
    vs additional OAD

    Source sentences

    Summary
    Body weight (baseline 71.5 kg) was reduced by 1.4 kg and 3.2 kg with semaglutide 0.5 mg and 1.0 mg, vs a 0.4-kg increase with additional OAD (ETD -1.84 kg and -3.59 kg; both P < .0001).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.
  8. 08HumanRandomized controlled trialEfficacy outcome

    More than 80% of semaglutide-treated Japanese participants reached HbA1c below 7.0%, the Japanese Diabetes Society target.

    In plain wordsMore than 80% of Japanese adults treated with semaglutide reached an HbA1c below 7.0%.

    Peptide
    Semaglutide
    Outcome
    Not applicableProportion reaching HbA1c below 7.0%
    Study

    n = 601

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.5 or 1.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Proportion with HbA1c <7.0%
    > 80%
    semaglutide

    Source sentences

    Summary
    For semaglutide-treated participants, >80% achieved an HbA1c concentration <7.0% (Japanese Diabetes Society target).
    1 context sentence
    Summary · context
    In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy.

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 postedNCT02207374

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 6014 Aug 2014 to 27 Feb 2016

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 7 Jan 2019

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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