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Completed

NCT Number: NCT04559815

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

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...

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Master Centre for Canada, Mississauga, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Oral semaglutide

Drug

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.

Primary outcomes

  1. Change in Glycated haemoglobin (HbA1c)

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

    Percent (%)-points

Secondary outcomes

  1. Relative change in body weight

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

    Percent

  2. Absolute change in body weight

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

    Kilogram (Kg)

  3. HbA1c <7% (Yes/No)

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

    Percentage of patients achieving or not achieving the target value

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

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

    Percentage of patients achieving or not achieving the reduction

  5. HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No)

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

    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 (V3) (week 34-44)

    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 (V3) (week 34-44)

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: PIONEER REAL

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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