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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05443191
• Collaborator: (none)
• Enrollment: 194
• Location: 1
• Anticipated Duration (Months): 21.1
• Patients Per Site Per Month: 9.2

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: 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 Finland
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Apr 5, 2023
• Anticipated Study Completion Date: Jun 3, 2024

Arms and Interventions

Arm

Intervention/Treatment

Semaglutide Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.

Drug: Semaglutide; Participants 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 participant 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)]

   Measured in percentage (%)-points

Secondary Outcome Measures

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

   Measured in percentage (%)

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

   Measured in Kilogram (Kg)

3. HbA1c < 7% [End of Study visit (V3) (week 34-44)]

   Measured as Yes or No

4. HbA1c reduction >=1%-points and body weight reduction of >=5% [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

   Measured as Yes or No

5. HbA1c reduction >=1%-points and body weight reduction of >=3% [From baseline (week 0) to End of Study visit (V3) (week 34-44)]

   Measured as Yes or No

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

   Measured in Total score

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

   Measured in Total score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 naive 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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Paris	La Défense	France	cedex

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05443191
• Other Study ID Numbers: NN9924-4541; U1111-1240-3808
• First Posted: Jul 5, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• 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: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 25, 2022