A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Israel, 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 Israel

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05443568
• Other study ID #: NN9924-4644
• Secondary ID: U1111-1240-4321
• Status: Enrolling by invitation
• Start date: March 9, 2023
• Est. completion date: November 3, 2024

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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 194
• Est. completion date: November 3, 2024
• Est. primary completion date: November 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)

2. Diagnosed with type 2 diabetes mellitus

3. 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

4. Male or female, age above or equal to 18 years at the time of signing informed consent

5. 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

6. 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:

1. Previous participation in this study. Participation is defined as having given informed consent in this study

2. Treatment with any investigational drug within 30 days prior to enrolment into the study

3. 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 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.

Locations

Country	Name	City	State
Israel	Novo Nordisk Investigational Site	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (Glycated haemoglobin)	Measured as percent-points	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary	Relative change in body weight	Measured as Percent	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary	Absolute change in body weight	Measured in Kilogram (Kg)	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary	HbA1c below 7%	Percentage of participants achieving or not achieving the target value	End of Study visit (V3) (week 34-44)
Secondary	HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5%	Percentage of participants achieving or not achieving the reduction	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary	HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3%	Percentage of patients achieving or not achieving the reduction	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary	DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction	The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.	End of Study visit (V3) (week 34-44)
Secondary	DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction	The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items.	From baseline (week 0) to End of Study visit (V3) (week 34-44)