A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice
- Registration Number
- NCT05230615
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
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 Specialist 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 below 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 below 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with type 2 diabetes Oral semaglutide once-daily oral semaglutide in a real-world adult population with type 2 diabetes
- Primary Outcome Measures
Name Time Method Change in HbA1c (Glycated haemoglobin) From baseline (week 0) to End of Study visit (V3) (week 34-44) %-points
- Secondary Outcome Measures
Name Time Method HbA1c below 7% End of Study visit (V3) (week 34-44) Yes or No
Relative change in body weight From baseline (week 0) to End of Study visit (V3) (week 34-44) Absolute change in body weight From baseline (week 0) to End of Study visit (V3) (week 34-44) Kilogram (Kg)
HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5% From baseline (week 0) to End of Study visit (V3) (week 34-44) Yes or No
HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3% From baseline (week 0) to End of Study visit (V3) (week 34-44) Yes or No
DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction End of Study visit (V3) (week 34-44) Total score
DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction From baseline (week 0) to End of Study visit (V3) (week 34-44) Total score
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇹Sesto San Giovanni, Italy