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

NCT05316662 | Completed

• 2 other identifiers: NN9924-4645U1111-1240-4396
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Measured in percentage (%)-points

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

Secondary Outcomes (7)

• Relative change in body weight

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

• Absolute change in body weight

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

• HbA1c < 7%

  End of Study visit (V3) (week 34- 44)

• HbA1c reduction >=1%-points and body weight reduction of >=5%

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

• HbA1c reduction >=1%-points and body weight reduction of >=3%

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

Study Arms (1)

Semaglutide

Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice.

Drug: Semaglutide

Interventions

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.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice.

You may qualify if:

• 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 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 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 14 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco, 44670, Mexico

Location

CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC

Guadalajara, Jalisco, 44670, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: April 6, 2022
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ME (2)