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Study · Observational study · n = 1,018 · 2025

12 results

Clinical Effectiveness of Oral Semaglutide in Women with Type 2 Diabetes: A Nationwide, Multicentre, Retrospective, Observational Study (Women_ENDO2S-RWD Substudy).

Reyes-Garcia R, Moreno-Pérez O, Guillen-Morote C, Modrego-Pardo I, Doulatram-Gamgaram VK, Casado Cases C, Arias Mendoza N, Tejera-Pérez C, Cárdenas-Salas J, Martínez-Fuster S, Lardiés-Sánchez B, Márquez-Pardo R and 4 more

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Pinés P, Tejera-Muñoz A, Fernández-García JC, On Behalf Of The Seen Diabetes Area

Nutrients17 Jul 2025Cited by 2 (Europe PMC)

PMID40732973 (opens in a new tab)PMCIDPMC12300082 (opens in a new tab)DOI10.3390/nu17142349 (opens in a new tab)PepBankPUB-40732973
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Summary

Background: Sex differences in type 2 diabetes (T2D) are a growing area of diabetes research. No data have been reported on sex differences with oral semaglutide (oSEMA) in a real-world setting. Methods: We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months. We evaluated in women with T2D (WWT2D) the clinical effectiveness of oSEMA and factors associated with clinical response and persistence. We also analyzed differences in baseline characteristics, clinical effectiveness, persistence rates and safety according to biological sex. Results: Of the 1018 subjects [median age: 63 years, body mass index (BMI): 33.8 kg/m2, HbA1c: 7.8%], 469 were WWT2D. In WWT2D, oSEMA reduced HbA1c by 0.7% [-0.1 to -1.3] and 0.9% [-0.2 to -1.5] at the 6- and 12-month FU visits, while weight decreased by 4.6% [2.0 to 7.9] and 7.2% [2.5 to 10.9], respectively. Weight loss was >10% in 29.8% of WWT2D (95% CI 25.8 to 34.1); meanwhile, the combined endpoint (HbA1c decrease ≥ 1% + weight reduction ≥ 5%) was achieved in 23.5% (95% CI 19.8 to 27.5%) of WWT2D at the 12-month FU visit. Achievement of glycaemic targets was similar in women and men (59.3% vs. 61.1%). We found no sex differences in weight loss (6.9% vs. 6.8%), oSEMA maintenance dose, persistence rate (76.3% vs. 77.3%), or adverse events. Conclusions: oSEMA was effective and safe in WWT2D in a real-world setting, with nearly one-third of patients reporting weight loss >10% and more than two-thirds achieving HbA1c < 7%. oSEMA showed no sex bias in terms of effectiveness and safety.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanObservational studyEfficacy outcome

    On oral semaglutide, achievement of glycaemic targets was similar in women (59.3%) and men (61.1%).

    In plain wordsOn oral semaglutide, women and men reached their blood sugar targets at a similar rate.

    Peptide
    Semaglutide
    Outcome
    No significant changeGlycaemic target achievement, women versus men
    Study

    n = 1,018

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

    Measurements

    Glycaemic target achievement
    59.3%
    women
    Glycaemic target achievement
    61.1%
    men

    Source sentences

    Summary
    Achievement of glycaemic targets was similar in women and men (59.3% vs. 61.1%).
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  2. 02HumanObservational studyEfficacy outcome

    On oral semaglutide, weight loss did not differ between women (6.9%) and men (6.8%).

    In plain wordsOn oral semaglutide, women and men lost a similar amount of weight.

    Peptide
    Semaglutide
    Outcome
    No significant changeWeight loss, women versus men
    Study

    n = 1,018

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

    Measurements

    Weight loss
    6.9%
    women
    Weight loss
    6.8%
    men

    Source sentences

    Summary
    We found no sex differences in weight loss (6.9% vs. 6.8%)
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  3. 03HumanObservational studyOther

    The oral semaglutide maintenance dose did not differ between women and men.

    In plain wordsWomen and men ended up on a similar maintenance dose of oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeMaintenance dose, women versus men
    Study

    n = 1,018

    Comparator
    Men
    Outcome group
    Patterns of use · Metabolic and weight
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    We found no sex differences in weight loss (6.9% vs. 6.8%), oSEMA maintenance dose
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  4. 04HumanObservational studyOther

    Persistence on oral semaglutide did not differ between women (76.3%) and men (77.3%).

    In plain wordsWomen and men stayed on oral semaglutide at a similar rate.

    Peptide
    Semaglutide
    Outcome
    No significant changePersistence rate, women versus men
    Study

    n = 1,018

    Comparator
    Men
    Outcome group
    Treatment adherence and retention · Metabolic and weight
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Persistence rate
    76.3%
    women
    Persistence rate
    77.3%
    men

    Source sentences

    Summary
    persistence rate (76.3% vs. 77.3%)
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  5. 05HumanObservational studySafety outcome

    In adults with type 2 diabetes on oral semaglutide, adverse events did not differ between women and men.

    In plain wordsWomen and men had a similar rate of side effects with oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    No significant changeAdverse events, women versus men
    Study

    n = 1,018

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

    Source sentences

    Summary
    We found no sex differences in weight loss (6.9% vs. 6.8%), oSEMA maintenance dose, persistence rate (76.3% vs. 77.3%), or adverse events.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  6. 06HumanObservational studyEfficacy outcome

    In women with type 2 diabetes, oral semaglutide reduced HbA1c by 0.7% at the 6-month follow-up visit.

    In plain wordsIn women with type 2 diabetes, oral semaglutide was linked to a fall in HbA1c of 0.7% after 6 months.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at 6 months in women
    Study

    n = 469

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

    Measurements

    HbA1c reduction
    0.7%
    women, 6 months

    Source sentences

    Summary
    In WWT2D, oSEMA reduced HbA1c by 0.7% [-0.1 to -1.3] and 0.9% [-0.2 to -1.5] at the 6- and 12-month FU visits, while weight decreased by 4.6% [2.0 to 7.9] and 7.2% [2.5 to 10.9], respectively.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  7. 07HumanObservational studyEfficacy outcome

    In women with type 2 diabetes, oral semaglutide reduced HbA1c by 0.9% at the 12-month follow-up visit.

    In plain wordsIn women with type 2 diabetes, oral semaglutide was linked to a fall in HbA1c of 0.9% after 12 months.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at 12 months in women
    Study

    n = 469

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · oral · 12 monthsAs given in this study (human).

    Measurements

    HbA1c reduction
    0.9%
    women, 12 months

    Source sentences

    Summary
    In WWT2D, oSEMA reduced HbA1c by 0.7% [-0.1 to -1.3] and 0.9% [-0.2 to -1.5] at the 6- and 12-month FU visits, while weight decreased by 4.6% [2.0 to 7.9] and 7.2% [2.5 to 10.9], respectively.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  8. 08HumanObservational studyEfficacy outcome

    In women with type 2 diabetes, body weight decreased by 4.6% at the 6-month follow-up visit on oral semaglutide.

    In plain wordsIn women with type 2 diabetes, body weight fell by 4.6% after 6 months on oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseWeight change at 6 months in women
    Study

    n = 469

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

    Measurements

    Weight decrease
    4.6%
    women, 6 months

    Source sentences

    Summary
    In WWT2D, oSEMA reduced HbA1c by 0.7% [-0.1 to -1.3] and 0.9% [-0.2 to -1.5] at the 6- and 12-month FU visits, while weight decreased by 4.6% [2.0 to 7.9] and 7.2% [2.5 to 10.9], respectively.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  9. 09HumanObservational studyEfficacy outcome

    In women with type 2 diabetes, body weight decreased by 7.2% at the 12-month follow-up visit on oral semaglutide.

    In plain wordsIn women with type 2 diabetes, body weight fell by 7.2% after 12 months on oral semaglutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseWeight change at 12 months in women
    Study

    n = 469

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · oral · 12 monthsAs given in this study (human).

    Measurements

    Weight decrease
    7.2%
    women, 12 months

    Source sentences

    Summary
    In WWT2D, oSEMA reduced HbA1c by 0.7% [-0.1 to -1.3] and 0.9% [-0.2 to -1.5] at the 6- and 12-month FU visits, while weight decreased by 4.6% [2.0 to 7.9] and 7.2% [2.5 to 10.9], respectively.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  10. 10HumanObservational studyEfficacy outcome

    In women with type 2 diabetes on oral semaglutide, 29.8% lost more than 10% of body weight.

    In plain wordsIn women with type 2 diabetes on oral semaglutide, 29.8% lost more than 10% of their body weight.

    Peptide
    Semaglutide
    Outcome
    IncreaseWeight loss over 10% at 12 months in women
    Study

    n = 469

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · oral · 12 monthsAs given in this study (human).

    Measurements

    Proportion with weight loss over 10%
    29.8%
    women

    Source sentences

    Summary
    Weight loss was >10% in 29.8% of WWT2D (95% CI 25.8 to 34.1)
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  11. 11HumanObservational studyEfficacy outcome

    In women with type 2 diabetes on oral semaglutide, 23.5% reached the combined endpoint of an HbA1c decrease of 1% or more with a weight reduction of 5% or more at 12 months.

    In plain wordsIn women with type 2 diabetes on oral semaglutide, 23.5% cut HbA1c by 1 point and body weight by 5% after 12 months.

    Peptide
    Semaglutide
    Outcome
    IncreaseCombined endpoint (HbA1c decrease of 1% or more plus weight reduction of 5% or more)
    Study

    n = 469

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · oral · 12 monthsAs given in this study (human).

    Measurements

    Proportion reaching combined endpoint
    23.5%
    women, 12 months

    Source sentences

    Summary
    meanwhile, the combined endpoint (HbA1c decrease ≥ 1% + weight reduction ≥ 5%) was achieved in 23.5% (95% CI 19.8 to 27.5%) of WWT2D at the 12-month FU visit.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.
  12. 12HumanObservational studyEfficacy outcome

    In women with type 2 diabetes on oral semaglutide, more than two-thirds reached an HbA1c below 7%.

    In plain wordsIn women with type 2 diabetes on oral semaglutide, more than two-thirds reached an HbA1c below 7%.

    Peptide
    Semaglutide
    Outcome
    IncreaseHbA1c below 7% in women
    Study

    n = 469

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

    Source sentences

    Summary
    more than two-thirds achieving HbA1c < 7%. oSEMA showed no sex bias in terms of effectiveness and safety.
    1 context sentence
    Summary · context
    We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months.

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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