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)

• ClinicalTrials.gov Identifier: NCT04559815
• Recruitment Status: Enrolling by invitation
• First Posted: September 23, 2020
• Last Update Posted: October 30, 2020
• Sponsor: Novo Nordisk A/S
• 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

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

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

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