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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04601740
Collaborator
(none)
194
Enrollment
1
Location
22.1
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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 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.

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 DiseaseIntervention/TreatmentPhase
  • Drug: Oral Semaglutide

Study Design

Study Type:
Observational
Anticipated Enrollment :
194 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 Netherlands
Actual Study Start Date :
Nov 17, 2020
Anticipated Primary Completion Date :
Sep 4, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Change in Glycated haemoglobin (HbA1c ) [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

    Percent-points

Secondary Outcome Measures

  1. Relative change in body weight [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

    Percent

  2. Absolute change in body weight [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

    Kilogram (Kg)

  3. HbA1c <7% (Yes/No) [End of Study visit (V3) (week 34-44)]

    Percentage of patients achieving or not achieving the target value

  4. HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No) [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

    Percentage of patients achieving or not achieving the reduction

  5. HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No) [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

    Percentage of patients achieving or not achieving the reduction

  6. Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction [End of Study visit (V3) (week 34-44)]

    Total score

  7. Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

    Total score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteAlphen A/d RijnNetherlands2408 AV

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04601740
Other Study ID Numbers:
  • NN9924-4643
  • U1111-1240-4249
First Posted:
Oct 26, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021