Clinical trial NCT05316662: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Mexico, as Part of Local Clinical Practice
Official title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
measure: Absolute change in body weight
timeFrame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
measure: HbA1c < 7%
timeFrame: End of Study visit (V3) (week 34- 44)
measure: HbA1c reduction >=1%-points and body weight reduction of >=5%
timeFrame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
measure: HbA1c reduction >=1%-points and body weight reduction of >=3%
timeFrame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
measure: DTSQc, relative treatment satisfaction
timeFrame: End of Study visit (V3) (week 34- 44)
measure: DTSQs, change in absolute treatment satisfaction
timeFrame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Clinica Endocrinologica de Jalisco
state: Jalisco
city: Guadalajara
country: Mexico
facility: CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC
state: Jalisco
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: