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CompletedNCT04601753PIONEER REALUpdated Sep 24, 2025

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

An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
194
Ages
18 Years and older
Sex
All
01

Study 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 their blood sugar levels. Participants will get Rybelsus® as prescribed to them 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 normally scheduled visits with the study doctor.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 194 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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 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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
194 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with type 2 diabetes

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

    Drug: Oral Semaglutide

Interventions

  • DrugOral Semaglutide

    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.

06

What researchers measure

Primary outcomes

  1. Change in Glycated haemoglobin (HbA1c )

    Percent-points

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

Secondary outcomes

  1. Relative change in body weight

    Percent

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

  2. Absolute change in body weight

    Kilogram (Kg)

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

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

    Total score

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

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

    Total score

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

07

Study locations

1 site
  • Master Centre for Sweden
    Malmö, 202 15, Sweden
08

References and documents

Publications

  • Gonzalez-Galvez G, Garnica-Cuellar JC, Colin-Garcia MA, Ferreira-Hermosillo A, Jimenez-Ramos SA, Contreras-Sandoval AY, Cruz-Puente P, Duarte-Vega M. A Multicentre, Prospective, Non-Interventional Single-Arm Study Investigating the Impact of Once-Daily Oral Semaglutide in a Real-World Adult Population With Type 2 Diabetes in Mexico. Endocrinol Diabetes Metab. 2026 May;9(3):e70219. doi: 10.1002/edm2.70219. PubMed 41986942 ↗
  • 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 ↗
  • Catrina SB, Amadid H, Braae UC, Dereke J, Ekberg NR, Klanger B, Jansson S. PIONEER REAL Sweden: A Multicentre, Prospective, Real-World Observational Study of Oral Semaglutide Use in Adults with Type 2 Diabetes in Swedish Clinical Practice. Diabetes Ther. 2024 Sep;15(9):2079-2095. doi: 10.1007/s13300-024-01614-6. Epub 2024 Jul 25. PubMed 39052163 ↗

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04601753
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 26, 2020
Start date
Nov 12, 2020
Primary completion
Mar 3, 2023
Completion
Mar 3, 2023
Last update
Sep 24, 2025

Study contacts

Clinical Transparency (dept. 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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