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Trial · Observational

CompletedPhase not statedRegistry data

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

Short name PIONEER REAL

NCTNCT05443334 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4547Other idU1111-1240-4149
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
465 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not stated
Countries
1 country

Spain

Start
28 Jul 2022
Primary completion
4 Jul 2024
Completion
4 Jul 2024
First posted
5 Jul 2022
Last update posted
24 Sept 2025
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph –

    PIONEER REAL

    NCT05443334

    28 Jul 2022 to 4 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

Interventions

  • SemaglutideDrug

Arms1

  • Other

    Participants with type 2 diabetes

    Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Registry description

    Measured in percentage (%)-points

Secondary outcomes(7)

  1. Relative change in body weight

    Time frame · From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Registry description

    Measured in percentage (%)

  2. Absolute change in body weight

    Time frame · From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Registry description

    Measured in Kilogram (Kg)

  3. HbA1c < 7%

    Time frame · End of Study visit (V3) (week 34- 44)

    Registry description

    Measured as Yes or No

  4. HbA1c reduction >=1%-points and body weight reduction of >=5%

    Time frame · From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Registry description

    Measured as Yes or No

  5. HbA1c reduction >=1%-points and body weight reduction of >=3%

    Time frame · From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Registry description

    Measured as Yes or No

  6. DTSQc, relative treatment satisfaction

    Time frame · End of Study visit (V3) (week 34- 44)

    Registry description

    Measured in Total score

  7. DTSQs, change in absolute treatment satisfaction

    Time frame · From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Registry description

    Measured in Total score

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: 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 et al. 2025Diabetes, obesity & metabolismcited by 6

PMID 40555703PMC12326947DOI 10.1111/dom.16523PUB-40555703

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * Diagnosed with type 2 diabetes mellitus * The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study * Male or female, age above or equal to 18 years at the time of signing informed consent * Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice * Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study * Treatment with any investigational drug within 30 days prior to enrolment into the study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

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