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A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Canada, 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: NCT04559815
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date September 16, 2020
First Posted Date September 23, 2020
Last Update Posted Date October 30, 2020
Actual Study Start Date October 21, 2020
Estimated Primary Completion Date August 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2020)
Change in Glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
Percent (%)-points
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2020)
  • Relative change in body weight [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
    Percent
  • Absolute change in body weight [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
    Kilogram (Kg)
  • HbA1c <7% (Yes/No) [ Time Frame: End of Study visit (V3) (week 34-44) ]
    Percentage of patients achieving or not achieving the target value
  • HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No) [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
    Percentage of patients achieving or not achieving the reduction
  • HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No) [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
    Percentage of patients achieving or not achieving the reduction
  • Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction [ Time Frame: End of Study visit (V3) (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.
  • Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction [ Time Frame: From baseline (week 0) to End of Study visit (V3) (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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Canada, 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 Canada
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 participants blood sugar levels. Participants will get Rybelsus® as prescribed to them by their 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Condition Diabetes Mellitus, Type 2
Intervention 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.
Study Groups/Cohorts Patients with type 2 diabetes
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Intervention: Drug: Oral Semaglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: September 16, 2020)
194
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 19, 2022
Estimated Primary Completion Date August 19, 2022   (Final data collection date for primary outcome measure)
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 naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04559815
Other Study ID Numbers NN9924-4543
U1111-1240-3985 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2020