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Study · Observational study · n = 24 · 2024

8 results

Efficacy and safety of oral semaglutide in older patients with type 2 diabetes: a retrospective observational study (the OTARU-SEMA study).

Oe Y, Nomoto H, Cho KY, Yokozeki K, Ono T, Miya A, Kameda H, Nakamura A, Arimura Y, Atsumi T

BMC endocrine disorders24 Jul 2024Cited by 6 (Europe PMC)

PMID39049060 (opens in a new tab)PMCIDPMC11267784 (opens in a new tab)DOI10.1186/s12902-024-01658-6 (opens in a new tab)PepBankPUB-39049060
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Summary

BackgroundOral semaglutide in older subjects with type 2 diabetes was as effective as in younger subjects, according to phase 3 clinical trials. However, its efficacy can be limited in very aged population, due to the presence of impaired cognitive function and the complex instructions for its use. Here, we investigated its efficacy and safety by further age bracket in older subjects in real-world.MethodsWe retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment. The primary outcome was the change in glycated hemoglobin (HbA1c) over 6 months. Adverse events and cognitive function were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) and the Hasegawa Dementia Rating Scale-revised (HDS-R). The achievement rate of glycemic targets was evaluated based on the age, health status of subjects and their use of anti-diabetic agents which can cause hypoglycemia, with additional analysis between two subgroups; early (65-74) versus late (≥ 75) older. Furthermore, we evaluated the relationships between their improvements in HbA1c and the baseline characteristics of the subjects, including their cognitive function and insulin secretory capacity.ResultsWe studied the efficacy of the drug in 24 subjects. Their HbA1c and body weight significantly decreased (- 13.1 ± 7.5 mmol/mol and - 3.0 ± 2.4 kg, respectively; P < 0.01). Although cognitive function was lower in the late older group (r = -0.57, P < 0.01), changes in HbA1c showed no difference between the two subgroups (P = 0.66) and it correlated with the insulin secretory capacity rather than cognitive function (r = -0.49, P < 0.05). Glycemic targets were more likely to be achieved (P < 0.01), but HbA1c excessively decreased in late older subjects who were also using insulin or an insulin secretagogue. The frequency of adverse events was similar to that in the clinical trial, whereas discontinuation of medication were more frequent among the late older subjects (Early; n = 2, Late; n = 4).ConclusionsOral semaglutide improves the glycemic control of older subjects, but it might be a risk for potential hypoglycemia and discontinuation because of adverse events in subjects of ≥ 75 years. Attention should be paid to insulin secretory capacity and concomitant medications rather than concern about adherence.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

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

  1. 01HumanObservational studyEfficacy outcome

    In older adults (over 65 years) with type 2 diabetes in real-world practice, HbA1c fell significantly on oral semaglutide.

    In plain wordsIn older adults with type 2 diabetes, HbA1c fell during treatment with oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change over 6 months
    Study

    n = 24

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · oral · 6 monthsAs given in this study (human).

    Measurements

    HbA1c change
    −13.1 mmol/mol
    oral semaglutide

    Source sentences

    Summary
    Their HbA1c and body weight significantly decreased (- 13.1 ± 7.5 mmol/mol and - 3.0 ± 2.4 kg, respectively; P < 0.01).
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  2. 02HumanObservational studyEfficacy outcome

    In older adults (over 65 years) with type 2 diabetes in real-world practice, body weight fell significantly on oral semaglutide.

    In plain wordsIn older adults with type 2 diabetes, body weight fell during treatment with oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change
    Study

    n = 24

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · oral · 6 monthsAs given in this study (human).

    Measurements

    Body weight change
    −3 kg
    oral semaglutide

    Source sentences

    Summary
    Their HbA1c and body weight significantly decreased (- 13.1 ± 7.5 mmol/mol and - 3.0 ± 2.4 kg, respectively; P < 0.01).
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  3. 03HumanObservational studyEfficacy outcome

    In older adults with type 2 diabetes on oral semaglutide, the HbA1c change did not differ between early older (65-74 years) and late older (75 years or more) subjects.

    In plain wordsIn older adults on oral semaglutide, HbA1c fell by a similar amount in the two age groups.

    Peptide
    Semaglutide
    Outcome
    No significant changeHbA1c change, early versus late older subgroups
    Study

    n: not reported in source

    Comparator
    Late older (>=75 years) versus early older (65-74 years)
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    changes in HbA1c showed no difference between the two subgroups (P = 0.66)
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  4. 04HumanObservational studyMechanism

    In older adults with type 2 diabetes on oral semaglutide, the HbA1c change correlated with insulin secretory capacity rather than with cognitive function.

    In plain wordsIn older adults on oral semaglutide, the HbA1c fall was linked to the body's insulin output rather than to thinking ability.

    Peptide
    Semaglutide
    Outcome
    Not applicableCorrelation of HbA1c change with insulin secretory capacity
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Endocrine and hormones
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Correlation coefficient r
    −0.49 r
    HbA1c change versus insulin secretory capacity

    Source sentences

    Summary
    it correlated with the insulin secretory capacity rather than cognitive function (r = -0.49, P < 0.05)
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  5. 05HumanObservational studyEfficacy outcome

    In older adults with type 2 diabetes on oral semaglutide, glycemic targets were more likely to be achieved; the abstract does not state the comparison group.

    In plain wordsIn older adults on oral semaglutide, more people were likely to reach their blood sugar targets.

    Peptide
    Semaglutide
    Outcome
    IncreaseAchievement of glycemic targets
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Glycemic targets were more likely to be achieved (P < 0.01)
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  6. 06HumanObservational studySafety outcome

    In late older subjects (75 years or more) who also used insulin or an insulin secretagogue, HbA1c decreased excessively on oral semaglutide.

    In plain wordsIn people aged 75 or older who also used insulin or a similar drug, HbA1c fell too far on oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseExcessive HbA1c decrease in late older subjects using insulin or secretagogue
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    but HbA1c excessively decreased in late older subjects who were also using insulin or an insulin secretagogue.
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  7. 07HumanObservational studySafety outcome

    In older adults with type 2 diabetes, the frequency of adverse events on oral semaglutide was similar to that in the clinical trial.

    In plain wordsIn older adults on oral semaglutide, side effects occurred about as often as in the clinical trial.

    Peptide
    Semaglutide
    Outcome
    No significant changeFrequency of adverse events
    Study

    n: not reported in source

    Comparator
    Phase 3 clinical trial
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    The frequency of adverse events was similar to that in the clinical trial
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.
  8. 08HumanObservational studySafety outcome

    In older adults with type 2 diabetes on oral semaglutide, discontinuation was more frequent among late older subjects (75 years or more) than among early older subjects.

    In plain wordsIn older adults on oral semaglutide, people aged 75 or older stopped the medicine more often than those aged 65 to 74.

    Peptide
    Semaglutide
    Outcome
    IncreaseDiscontinuation of medication, late versus early older
    Study

    n: not reported in source

    Comparator
    Early older (65-74 years)
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Discontinuations
    2 subjects
    early older
    Discontinuations
    4 subjects
    late older

    Source sentences

    Summary
    discontinuation of medication were more frequent among the late older subjects (Early; n = 2, Late; n = 4).
    2 context sentences
    Summary · context
    We retrospectively studied subjects > 65 years of age with type 2 diabetes who started oral semaglutide treatment.
    Summary · context
    We studied the efficacy of the drug in 24 subjects.

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

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, 00:04 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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