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A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in the United Kingdom, 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: NCT04862923
Recruitment Status : Enrolling by invitation
First Posted : April 28, 2021
Last Update Posted : November 18, 2022
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. Participants will get Rybelsus® as prescribed 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. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits 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
Estimated Enrollment : 381 participants
Observational Model: Cohort
Time Perspective: Prospective
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 the United Kingdom
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : August 24, 2023
Estimated Study Completion Date : August 24, 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 treat the participant with a given product is independent of the decision to include him/her in the 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


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 reduction

  4. HbA1c reduction greater than or equal to 1 percent-points and body weight reduction 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 reduction

  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 reduction

  6. Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction [ Time Frame: End of Study visit (Visit 3) (week 34-44) ]
    The change version (DTSQc) has the same 8 items as the status version but is reworded to direct the patients to rate their change in treatment satisfaction compared to before being treated with oral semaglutide. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change.

  7. Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction [ Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) ]
    The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with type 2 diabetes who are 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 18 years at the time of signing informed consent
  • Available glycated haemoglobin (HbA1c) value less 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 14 days or less.

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): NCT04862923


Locations
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United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
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: NCT04862923    
Other Study ID Numbers: NN9924-4539
U1111-1240-3705 ( Other Identifier: World Health Organization (WHO) )
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022
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