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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 the United Kingdom, as Part of Local Clinical Practice

Short name PIONEER REAL

NCTNCT04862923 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4539Other idU1111-1240-3705
Open at ClinicalTrials.govAsk about this trial

Overview

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

United Kingdom

Start
12 May 2021
Primary completion
31 Aug 2023
Completion
31 Aug 2023
First posted
28 Apr 2021
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
2021202220232024
  1. Ph –

    PIONEER REAL

    NCT04862923

    12 May 2021 to 31 Aug 2023

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 how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed by the 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. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor.

Interventions

  • Oral semaglutideDrug

Arms1

  • Other

    Patients with type 2 diabetes

    Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in glycated haemoglobin (HbA1c)

    Time frame · From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

    Registry description

    percent-points

Secondary outcomes(7)

  1. Relative change in body weight

    Time frame · From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

    Registry description

    percent

  2. Absolute change in body weight

    Time frame · From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

    Registry description

    Kilogram (Kg)

  3. HbA1c less than 7 percent (Yes/No)

    Time frame · End of Study visit (Visit 3) (week 34-44)

    Registry description

    percentage of patients achieving or not achieving the reduction

  4. HbA1c reduction greater than or equal to 1 percent-points and body weight reduction greater than or equal to 5 percent (Yes/No)

    Time frame · From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

    Registry description

    percentage of patients achieving or not achieving the reduction

  5. HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)

    Time frame · From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

    Registry description

    percentage of patients achieving or not achieving the reduction

  6. Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction

    Time frame · End of Study visit (Visit 3) (week 34-44)

    Registry description

    The change version (DTSQc) has the same 8 items as the status version but is reworded to direct the patients to rate their change in treatment satisfaction compared to before being treated with oral semaglutide. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change.

  7. Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction

    Time frame · From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

    Registry description

    The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively.

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2024

9 results

PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes.

Saravanan et al. 2024Advances in therapycited by 9

PMID 39316289PMC11480173DOI 10.1007/s12325-024-02973-zPUB-39316289

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

More studies

1 study on this page

PubMed tag: none · 2025

Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.

Rudofsky et al. 2025Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 16

PMID 39535683PMC11760389DOI 10.1007/s13300-024-01668-6PUB-39535683

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not stated
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 glycated haemoglobin (HbA1c) value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice * Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of 14 days or less. 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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