AzTrials
AzTrials

Diabetes Mellitus, Type 2PIONEER REALNCT04559815

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

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

Completed

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

Official record
Search all trials

Trial summary

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 participants blood sugar levels. Participants will get Rybelsus® as prescribed to them by their 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?
Oral Semaglutide
How many people
194 participants
Where
2 sitesCanada
Study dates
21 Oct 2020to 14 Sep 2022
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: Adult patients with type 2 diabetes and naïve 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 naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 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.

Canada2 sites

  • Master Centre for Canada

    Mississauga, Ontario, L4W 4XI

  • Dr. Nigel N Jagan Medicine Professional Corporation

    Whitby, Ontario, L1N 2L1

Other trials in Canada

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 Canada

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 participants blood sugar levels. Participants will get Rybelsus® as prescribed to them by their 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...

Being tested
Oral 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.

  • Oral SemaglutideDrug

    Patients 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 patient in this study.

Study groups in NCT04559815
Study groupRoleWhat they receive
Patients with type 2 diabetesAdult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Receives: Drug: Oral Semaglutide

What is being measured

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

  1. Change in Glycated haemoglobin (HbA1c)

    Percent (%)-points

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

Secondary outcomes (7)

  1. Relative change in body weight

    Percent

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

  2. Absolute change in body weight

    Kilogram (Kg)

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

  3. HbA1c <7% (Yes/No)

    Percentage of patients achieving or not achieving the target value

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

  4. HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No)

    Percentage of patients achieving or not achieving the reduction

    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% (Yes/No)

    Percentage of patients achieving or not achieving the reduction

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

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

    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.

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

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

    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.

    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 posted23 Sep 2020
  2. Study start21 Oct 2020
  3. Primary completion14 Sep 2022
  4. Study completion14 Sep 2022

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
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559815
Sponsor's protocol ID
NN9924-4543
Other IDs
U1111-1240-3985
Acronym
PIONEER REAL
Status last verified
Nov 2025
First submitted
16 Sep 2020
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Publications

  • Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13.

    PubMed 39535683

  • Jain AB, Reichert SM, Amadid H, Braae UC, Bradley RM, Kim JW, Soo V, Yale JF. Use of once-daily oral semaglutide and associated clinical outcomes among adults with type 2 diabetes in routine clinical practice in Canada: A multicentre, prospective real-world study (PIONEER REAL Canada). Diabetes Obes Metab. 2024 May;26(5):1799-1807. doi: 10.1111/dom.15493. Epub 2024 Mar 11.

    PubMed 38468125

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 Canada.

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 5 Dec 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 Canada. 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 Glycated haemoglobin (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 NCT04559815, which also lists 2 linked publications.

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 5 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in