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Completed

NCT Number: NCT05443568

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Master Centre for Israel

Kfar Saba, 44425, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral semaglutide

Drug

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.

Primary outcomes

  1. Change in HbA1c (Glycated haemoglobin)

    Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Measured as percent-points

Secondary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Measured as Percent

  2. Absolute change in body weight

    Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Measured in Kilogram (Kg)

  3. HbA1c below 7%

    Time frame: End of Study visit (V3) (week 34-44)

    Percentage of participants achieving or not achieving the target value

  4. HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5%

    Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Percentage of participants achieving or not achieving the reduction

  5. HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3%

    Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

    Percentage of patients achieving or not achieving the reduction

  6. DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction

    Time frame: End of Study visit (V3) (week 34-44)

    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.

  7. DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction

    Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: PIONEER REAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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