- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601753
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Sweden, as Part of Local Clinical Practice (PIONEER REAL)
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 Sweden
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Malmö, Sweden, 202 15
- Novo Nordisk Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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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Total score
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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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Total score
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From baseline (week 0) to End of Study visit (V3) (week 34-44)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9924-4545
- U1111-1240-4039 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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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