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Completed

NCT Number: NCT05502562

A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India

The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.

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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

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 (T2D).
  • 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 A1c (HbA1c) value less than 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 naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to (<=) 14 days.

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Any prior or current use of oral semaglutide.
  • Hypersensitivity to oral semaglutide or to any of the excipients.
  • Treatment with any investigational drug within 30 days prior to signing of informed consent.
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Treatment and study plan

Oral semaglutide

Drug

Participants 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 participant in this study.

Primary outcomes

  1. Change in Glycated haemoglobin A1c (HbA1c)

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

    Measured as percentage (%)-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 in percentage (%).

  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. Glycated haemoglobin A1c (HbA1c) less than (<) 7%

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

    Measured as Yes or No.

  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)

    Measured as Yes or No.

  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)

    Measured as Yes or No.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Initiation of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in India

Acronym: PIONEER REAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2022
Registry last updated
Sep 19, 2024

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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