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Diabetes Mellitus, Type 2PIONEER REALNCT05443334

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

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide
How many people
465 participants
Where
2 sitesSpain
Study dates
28 Jul 2022to 4 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Master Centre for Spain

    Barcelona, 08025

  • Master Centre for Spain

    Madrid, 28033

Other trials in Spain

About this study

Official title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Spain

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.

Being tested
Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. 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 participant in this study.

Study groups in NCT05443334
Study groupRoleWhat they receive
Participants with type 2 diabetesParticipants with type 2 diabetes and naive to injectable glucose-lowering treatment.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Measured in percentage (%)-points

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

Secondary outcomes (7)

  1. Relative change in body weight

    Measured in percentage (%)

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  2. Absolute change in body weight

    Measured in Kilogram (Kg)

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  3. HbA1c < 7%

    Measured as Yes or No

    Measured: End of Study visit (V3) (week 34- 44)

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

    Measured as Yes or No

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

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

    Measured as Yes or No

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  6. DTSQc, relative treatment satisfaction

    Measured in Total score

    Measured: End of Study visit (V3) (week 34- 44)

  7. DTSQs, change in absolute treatment satisfaction

    Measured in Total score

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start28 Jul 2022
  3. Primary completion4 Jul 2024
  4. Study completion4 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443334
Sponsor's protocol ID
NN9924-4547
Other IDs
U1111-1240-4149
Acronym
PIONEER REAL
Status last verified
Sep 2025
First submitted
29 Jun 2022
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Delgado Alvarez E, Morales Portillo C, Abreu Padin C, Aliaga Verdugo A, Piera Carbonell A, Cadenas Gonzalez A, Amor Valero J, Gonzalez Lopez V, Rasmussen CL, Scheuer SH, Bellido Guerrero D. PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes. Diabetes Obes Metab. 2025 Sep;27(9):4812-4824. doi: 10.1111/dom.16523. Epub 2025 Jun 24.

    PubMed 40555703

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443334, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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