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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Oral semaglutide

• Study Type: Observational
• Enrollment (Estimated): 194

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44425
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (Glycated haemoglobin)	Measured as percent-points	From baseline (week 0) to End of Study visit (V3) (week 34-44)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in body weight	Measured in Kilogram (Kg)	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Relative change in body weight	Measured as Percent	From baseline (week 0) to End of Study visit (V3) (week 34-44)
HbA1c below 7%	Percentage of participants achieving or not achieving the target value	End of Study visit (V3) (week 34-44)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): November 3, 2024
• Study Completion (Estimated): November 3, 2024

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9924-4644; U1111-1240-4321 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com