- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04537637
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Denmark, as Part of Local Clinical Practice (PIONEER REAL)
January 9, 2024 updated by: Novo Nordisk A/S
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 Denmark
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 their normally scheduled visits with the study doctor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
99
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen S, Denmark, 2300
- Master Centre for Denmark
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Søborg, Denmark, 2860
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with type 2 diabetes
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glycated haemoglobin (HbA1c )
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Percent-points
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative change in body weight
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Percent
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Absolute change in body weight
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Kilogram (Kg)
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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HbA1c <7% (Yes/No)
Time Frame: End of Study visit (V3) (week 34-44)
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Percentage of patients achieving or not achieving the target value.
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End of Study visit (V3) (week 34-44)
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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)
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Percentage of patients achieving or not achieving the reduction.
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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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)
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Percentage of patients achieving or not achieving the reduction.
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction
Time Frame: End of Study visit (V3) (week 34-44)
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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.
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End of Study visit (V3) (week 34-44)
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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)
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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.
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2020
Primary Completion (Actual)
May 8, 2023
Study Completion (Actual)
May 8, 2023
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 3, 2020
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9924-4548
- U1111-1240-4198 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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