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Study · Observational study · 2025

10 results

PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes.

Delgado Álvarez E, Morales Portillo C, Abreu Padín C, Aliaga Verdugo A, Piera Carbonell A, Cadenas González A, Amor Valero J, González López V, Rasmussen CL, Scheuer SH, Bellido Guerrero D

Diabetes, obesity & metabolism24 Jun 2025Cited by 6 (Europe PMC)

PMID40555703 (opens in a new tab)PMCIDPMC12326947 (opens in a new tab)DOI10.1111/dom.16523 (opens in a new tab)PepBankPUB-40555703
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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-ND. Results still quote short attributed sentences.

Results from this study10

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

  1. 01HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes in routine care in Spain, oral semaglutide lowered HbA1c by 1.4 %-points from baseline to end of study.

    In plain wordsIn adults with type 2 diabetes in routine care, oral semaglutide lowered HbA1c, a blood sugar measure, from baseline to the end of the study.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change from baseline to end of study
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −1.4 %-points
    all participants

    Source sentences

    Summary
    Estimated change in HbA1c was -1.4%-points (95%CI -1.5, -1.3; p < 0.0001)
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  2. 02HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes in routine care in Spain, oral semaglutide reduced body weight by 6.8% from baseline to end of study.

    In plain wordsIn adults with type 2 diabetes in routine care, oral semaglutide was followed by weight loss from baseline to the end of the study.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change from baseline to end of study
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Body weight change
    −6.8%
    all participants

    Source sentences

    Summary
    in body weight -6.8% (95%CI -7.4, -6.1; p < 0.0001).
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  3. 03HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes in routine care, 77.4% of those treated with oral semaglutide reached HbA1c below 7% at end of study.

    In plain wordsIn adults with type 2 diabetes in routine care, about three in four people taking oral semaglutide reached an HbA1c below 7%.

    Peptide
    Semaglutide
    Outcome
    Not applicableProportion with HbA1c below 7% at end of study
    Study

    n: not reported in source

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

    Measurements

    Proportion with HbA1c <7%
    77.4%
    end of study

    Source sentences

    Summary
    77.4% of participants achieved an HbA1c level <7%
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  4. 04HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes in routine care, treatment satisfaction increased with oral semaglutide.

    In plain wordsIn adults with type 2 diabetes in routine care, people reported higher treatment satisfaction after starting oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    IncreaseTreatment satisfaction
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Treatment satisfaction increased, and no new safety concerns were identified.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  5. 05HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes who also used SGLT2 inhibitors, oral semaglutide lowered HbA1c by 1.8 %-points.

    In plain wordsIn adults with type 2 diabetes who also took SGLT2 inhibitors, oral semaglutide was followed by lower HbA1c.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change in participants using SGLT2 inhibitors
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −1.8 %-points
    with SGLT2i

    Source sentences

    Summary
    In participants using SGLT2is, change in HbA1c was -1.8%-points (95%CI -2.1, -1.6; p < 0.0001) versus -1.2%-points (95%CI -1.3, -1.1; p < 0.0001) in participants without SGLT2is.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  6. 06HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes who did not use SGLT2 inhibitors, oral semaglutide lowered HbA1c by 1.2 %-points.

    In plain wordsIn adults with type 2 diabetes who did not take SGLT2 inhibitors, oral semaglutide was followed by lower HbA1c.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change in participants not using SGLT2 inhibitors
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −1.2 %-points
    without SGLT2i

    Source sentences

    Summary
    In participants using SGLT2is, change in HbA1c was -1.8%-points (95%CI -2.1, -1.6; p < 0.0001) versus -1.2%-points (95%CI -1.3, -1.1; p < 0.0001) in participants without SGLT2is.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  7. 07HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes of up to 5 years duration, oral semaglutide lowered HbA1c by 1.4 %-points.

    In plain wordsIn adults with diabetes for up to five years, oral semaglutide was followed by lower HbA1c.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change with T2D duration up to 5 years
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −1.4 %-points
    T2D duration <=5 years

    Source sentences

    Summary
    HbA1c change was -1.4%-points (95%CI -1.6, -1.3; p 5 years.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  8. 08HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes of more than 5 years duration, oral semaglutide lowered HbA1c by 1.2 %-points.

    In plain wordsIn adults with diabetes for more than five years, oral semaglutide was followed by lower HbA1c.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change with T2D duration over 5 years
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −1.2 %-points
    T2D duration >5 years

    Source sentences

    Summary
    HbA1c change was -1.4%-points (95%CI -1.6, -1.3; p 5 years.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  9. 09HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes in routine care, 33.3% of those treated with oral semaglutide had at least a 1 %-point HbA1c reduction and at least 5% body weight reduction.

    In plain wordsIn adults with type 2 diabetes in routine care, one in three people on oral semaglutide had lower HbA1c and at least 5% weight loss.

    Peptide
    Semaglutide
    Outcome
    Not applicableProportion with HbA1c reduction of 1 %-point or more and weight reduction of 5% or more
    Study

    n: not reported in source

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

    Measurements

    Proportion with HbA1c drop >=1 %-point and weight loss >=5%
    33.3%
    end of study

    Source sentences

    Summary
    33.3% had ≥1%-point reduction in HbA1c and ≥5% body weight reduction.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.
  10. 10HumanObservational studySafety outcome

    In adults with type 2 diabetes in routine care, no new safety concerns were identified with oral semaglutide.

    In plain wordsIn adults with type 2 diabetes in routine care, no new safety concerns appeared with oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeNew safety concerns
    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
    no new safety concerns were identified.
    2 context sentences
    Summary · context
    This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks.
    Summary · context
    Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication.

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT05443334

A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice

Novo Nordisk A/Sn = 46528 Jul 2022 to 4 Jul 2024

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 24 Sept 2025

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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