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

March 27, 2024 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380015
        • Sanjivani Super Speciality Hospital
      • Ahmedabad, India, 382425
        • Rudraksha Institute of Medical Sciences Healthcare
      • Aurangabad, India, 431001
        • Samrat Endocrine Centre
      • Delhi, India, 110085
        • Naveda Healthcare Centre
      • Kochi, India, 68513
        • KMK Hospital
      • Kolkata, India, 700034
        • Ananda clinic
      • Kolkata, India, 700039
        • METTA Clinic (a unit of Healious Global Pvt. Ltd.)
      • Kolkata, India, 700107
        • Garfa Clinic, Diabetology
      • Kottayam, India, 686631
        • Vimala healthcare LLP
      • Mumbai, India, 400036
        • Dr. Bhagwat's Clinic
      • New Delhi, India, 110085
        • North Delhi Diabetes Centre
      • New Delhi, India, 110063
        • Dr. Makkars Diabetes and Obesity centre
      • Pune, India, 411013
        • Noble Hospital Pvt. Ltd.
    • Assam
      • Guwahati, Assam, India, 781008
        • Marwari Hospital and Research Centre
    • Gujarat
      • Surat, Gujarat, India, 395001
        • Shri B. D. Mehta Mahavir Heart Institute
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Center for Diabetes & Endocrine Care
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • KGN Diabetes and Endocrinology Centre
      • Pune, Maharashtra, India, 411021
        • Chellaram Diabetes Institute
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • IPGME&R and SSKM Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 participants with type 2 diabetes and naive to injectable glucose-lowering treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with type 2 diabetes
Adult participants with type 2 diabetes and naive to injectable glucose-lowering treatment.
Drug: Oral semaglutide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (week 0) to End of Study visit (V3) (week 34-44)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured in percentage (%).
From baseline (week 0) to End of Study visit (V3) (week 34-44)
Absolute change in body weight
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured in kilogram (kg).
From baseline (week 0) to End of Study visit (V3) (week 34-44)
Glycated haemoglobin A1c (HbA1c) less than (<) 7%
Time Frame: At End of Study visit (V3) (week 34-44)
Measured as Yes or No.
At 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%
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured as Yes or No.
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%
Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured as Yes or No.
From baseline (week 0) to End of Study visit (V3) (week 34-44)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

August 14, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4960
  • U1111-1270-0826 (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.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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