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

Last updated: May 29, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Semaglutide

Clinical Study ID

NCT05316662
NN9924-4645
U1111-1240-4396
  • Ages > 18
  • All Genders

Study Summary

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 participant's blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participant will be asked to complete a questionnaire about how the participant will take Rybelsus® tablets. Participant will complete this questionnaire during the normally scheduled visit with the study doctor. Participant will be asked to complete some questionnaires about diabetes treatment. Participant will complete these questionnaires during normally scheduled visits with the study doctor.

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 the protocol)

  • Diagnosed with type 2 diabetes mellitus

  • 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 HbA1c value less than or equal to 90 days prior to the 'Informed Consentand Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with localclinical practice

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

Exclusion

Exclusion Criteria:

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

  • Treatment with any investigational drug within 30 days prior to enrolment into thestudy

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

Study Design

Total Participants: 187
Treatment Group(s): 1
Primary Treatment: Semaglutide
Phase:
Study Start date:
April 06, 2022
Estimated Completion Date:
April 09, 2024

Connect with a study center

  • CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica Endocrinologica de Jalisco

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

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