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

Last updated: September 9, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Oral semaglutide

Clinical Study ID

NCT05502562
NN9924-4960
U1111-1270-0826
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-relatedactivities are any procedure related to recording of data according to theprotocol).

  • Diagnosed with type 2 diabetes (T2D).

  • The decision to initiate treatment with commercially available oral semaglutide hasbeen made by the patient/Legally Acceptable Representative (LAR) and the treatingphysician based on local label before and independently from the decision to includethe patient in this study.

  • Male or female, age above or equal to 18 years at the time of signing informedconsent.

  • Available glycated haemoglobin A1c (HbA1c) value less than or equal to (<=) 90 daysprior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1cmeasurement taken in relation with the 'Informed Consent and Treatment Initiationvisit' (V1) if in line with local clinical practice.

  • Treatment naive to injectable glucose-lowering drug(s). An exception is short-terminsulin treatment for acute illness for a total of less than or equal to (<=) 14days.

Exclusion

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having giveninformed 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 informedconsent.

  • Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within 30 days prior to signing of informed consent.

  • Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

Study Design

Total Participants: 388
Treatment Group(s): 1
Primary Treatment: Oral semaglutide
Phase:
Study Start date:
February 24, 2023
Estimated Completion Date:
June 03, 2024

Connect with a study center

  • Marwari Hospital and Research Centre

    Guwahati, Assam 781008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Guwahati, Assam 781008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Surat, Gujarat 395001
    India

    Site Not Available

  • Shri B. D. Mehta Mahavir Heart Institute

    Surat, Gujarat 395001
    India

    Site Not Available

  • Center for Diabetes & Endocrine Care

    Bangalore, Karnataka 560043
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka 560043
    India

    Site Not Available

  • KGN Diabetes and Endocrinology Centre

    Mumbai, Maharashtra 400008
    India

    Site Not Available

  • Chellaram Diabetes Institute

    Pune, Maharashtra 411021
    India

    Site Not Available

  • IPGME&R and SSKM Hospital

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Ahmedabad, 380015
    India

    Site Not Available

  • Rudraksha Institute of Medical Sciences Healthcare

    Ahmedabad, 382425
    India

    Site Not Available

  • Sanjivani Super Speciality Hospital

    Ahmedabad, 380015
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurangabad, 431001
    India

    Site Not Available

  • Samrat Endocrine Centre

    Aurangabad, 431001
    India

    Site Not Available

  • Naveda Healthcare Centre

    Delhi, 110085
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Delhi, 110085
    India

    Site Not Available

  • KMK Hospital

    Kochi, 68513
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kochi, 68513
    India

    Site Not Available

  • Ananda clinic

    Kolkata, 700034
    India

    Site Not Available

  • Garfa Clinic, Diabetology

    Kolkata, 700107
    India

    Site Not Available

  • METTA Clinic (a unit of Healious Global Pvt. Ltd.)

    Kolkata, 700039
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, 700034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kottayam, 686631
    India

    Site Not Available

  • Vimala healthcare LLP

    Kottayam, 686631
    India

    Site Not Available

  • Dr. Bhagwat's Clinic

    Mumbai, 400036
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, 400036
    India

    Site Not Available

  • Dr. Makkars Diabetes and Obesity centre

    New Delhi, 110063
    India

    Site Not Available

  • North Delhi Diabetes Centre

    New Delhi, 110085
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Delhi, 110063
    India

    Site Not Available

  • Noble Hospital Pvt. Ltd.

    Pune, 411013
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Pune, 411021
    India

    Site Not Available

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