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A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Japan, as Part of Local Clinical Practice (PIONEER REAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04878393
Recruitment Status : Completed
First Posted : May 7, 2021
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Oral semaglutide

Study Design
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Study Type : Observational
Actual Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 30, 2021
Actual Primary Completion Date : March 2, 2023
Actual Study Completion Date : March 2, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with type 2 diabetes
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment
 Drug: Oral semaglutide
Patients 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 patient in this study.


Outcome Measures
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Primary Outcome Measures :
  1. Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    percent-points

  2. Number of adverse event (AEs) [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    Count


Secondary Outcome Measures :
  1. Relative change in body weight [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    percent

  2. Absolute change in body weight [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    Kilogram (Kg)

  3. HbA1c less than 7 percent (Yes/No) [ Time Frame: End of Study visit (Visit 3) (week 34-44) ]
    Percentage of patients achieving or not achieving the target value

  4. HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 5 percent (Yes/No) [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    Percentage of patients achieving or not achieving the target value

  5. HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No) [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    Percentage of patients achieving or not achieving the target value

  6. Number of adverse reactions (ARs) [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    Count

  7. Number of serious adverse events (SAEs) [ Time Frame: From baseline (week 0) to End of Study visit (Visit3) (week 34-44) ]
    Count

  8. Number of serious adverse reactions (SARs) [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    Count


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878393


Locations
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Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency dept. 1452 Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04878393    
Other Study ID Numbers: NN9924-4613
U1111-1247-5339 ( Other Identifier: World Health Organization (WHO) )
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases