Clinical trial NCT04878393: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Japan, as Part of Local Clinical Practice
Official title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters and Safety Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 650
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

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 their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor.

The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit 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 20 years at the time of signing informed consent
* Available glycated haemoglobin (HbA1c) value greater than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice
* Treatment naïve 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 glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
measure: Number of adverse event (AEs)
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
measure: Absolute change in body weight
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
measure: HbA1c less than 7 percent (Yes/No)
timeFrame: End of Study visit (Visit 3) (week 34-44)
measure: HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 5 percent (Yes/No)
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
measure: HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
measure: Number of adverse reactions (ARs)
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
measure: Number of serious adverse events (SAEs)
timeFrame: From baseline (week 0) to End of Study visit (Visit3) (week 34-44)
measure: Number of serious adverse reactions (SARs)
timeFrame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Master Centre for Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 1452
role: STUDY_DIRECTOR
References:
citation: Suzuki R, Amadid H, Major-Pedersen A, Yabe D. PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan. J Diabetes Investig. 2024 Aug;15(8):1047-1056. doi: 10.1111/jdi.14219. Epub 2024 May 6.