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

Diabetes Mellitus, Type 2 Clinical Trial

— PIONEER REAL  

Official 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 the United Kingdom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862923
• Other study ID #: NN9924-4539
• Secondary ID: U1111-1240-3705
• Status: Completed
• Start date: May 12, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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 glycated haemoglobin (HbA1c) value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) 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 14 days or less.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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 treat the participant with a given product is independent of the decision to include him/her in the study.

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated haemoglobin (HbA1c)	percent-points	From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary	Relative change in body weight	percent	From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary	Absolute change in body weight	Kilogram (Kg)	From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary	HbA1c less than 7 percent (Yes/No)	percentage of patients achieving or not achieving the reduction	End of Study visit (Visit 3) (week 34-44)
Secondary	HbA1c reduction greater than or equal to 1 percent-points and body weight reduction greater than or equal to 5 percent (Yes/No)	percentage of patients achieving or not achieving the reduction	From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary	HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)	percentage of patients achieving or not achieving the reduction	From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary	Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction	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.	End of Study visit (Visit 3) (week 34-44)
Secondary	Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction	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.	From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)