A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Mexico, as Part of Local Clinical Practice
- Registration Number
- NCT05316662
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Semaglutide 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.
- Primary Outcome Measures
Name Time Method Change in HbA1c From baseline (week 0) to End of Study visit (V3) (week 34-44) Measured in percentage (%)-points
- Secondary Outcome Measures
Name Time Method Absolute change in body weight From baseline (week 0) to End of Study visit (V3) (week 34-44) Measured in Kilogram (Kg)
DTSQc, relative treatment satisfaction End of Study visit (V3) (week 34- 44) Measured in Total score
HbA1c < 7% End of Study visit (V3) (week 34- 44) Measured as Yes or No
DTSQs, change in absolute treatment satisfaction From baseline (week 0) to End of Study visit (V3) (week 34-44) Measured in Total score
Relative change in body weight From baseline (week 0) to End of Study visit (V3) (week 34-44) Measured in percentage (%)
HbA1c reduction >=1%-points and body weight reduction of >=5% From baseline (week 0) to End of Study visit (V3) (week 34-44) Measured as Yes or No
HbA1c reduction >=1%-points and body weight reduction of >=3% From baseline (week 0) to End of Study visit (V3) (week 34-44) Measured as Yes or No
Trial Locations
- Locations (2)
Centro de Investigacion Clinica Endocrinologica de Jalisco
🇲🇽Guadalajara, Jalisco, Mexico
CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC
🇲🇽Guadalajara, Jalisco, Mexico