PIONEER REAL: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Sweden, as Part of Local Clinical Practice
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with type 2 diabetes Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment. |
Drug: Oral 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.
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Outcome Measures
Primary Outcome Measures
- Change in Glycated haemoglobin (HbA1c ) [From baseline (week 0) to End of Study visit (V3) (week 34-44)]
Percent-points
Secondary Outcome Measures
- Relative change in body weight [From baseline (week 0) to End of Study visit (V3) (week 34-44)]
Percent
- Absolute change in body weight [From baseline (week 0) to End of Study visit (V3) (week 34-44)]
Kilogram (Kg)
- HbA1c <7% (Yes/No) [End of Study visit (V3) (week 34-44)]
Percentage of patients achieving or not achieving the target value
- HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No) [From baseline (week 0) to End of Study visit (V3) (week 34-44)]
Percentage of patients achieving or not achieving the reduction
- HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No) [From baseline (week 0) to End of Study visit (V3) (week 34-44)]
Percentage of patients achieving or not achieving the reduction
- Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction [End of Study visit (V3) (week 34-44)]
Total score
- Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction [From baseline (week 0) to End of Study visit (V3) (week 34-44)]
Total score
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
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Diagnosed with type 2 diabetes mellitus
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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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Male or female, age above or equal to 18 years at the time of signing informed consent
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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
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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:
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Previous participation in this study. Participation is defined as having given informed consent in this study
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Treatment with any investigational drug within 30 days prior to enrolment into the study
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Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Malmö | Sweden | 202 15 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9924-4545
- U1111-1240-4039