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

• ClinicalTrials.gov Identifier: NCT04537624
• Recruitment Status: Completed
• First Posted: September 3, 2020
• Last Update Posted: January 26, 2023
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

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
Diabetes Mellitus, Type 2	Drug: Oral Semaglutide

Study Design

• Study Type: Observational
• Actual 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 Switzerland
• Actual Study Start Date: August 24, 2020
• Actual Primary Completion Date: December 20, 2022
• Actual Study Completion Date: December 20, 2022

Groups and Cohorts

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 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 ) [ Time Frame: From baseline (week 0) to End of Study visit (V3) (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 (V3) (week 34-44) ]
   percent
2. Absolute change in body weight [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
   Kilogram (Kg)
3. HbA1c <7% (Yes/No) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44) ]
   Percentage of patients achieving or not achieving the reduction

Eligibility Criteria

• 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 and 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 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

Switzerland

Novo Nordisk Investigational Site

Zurich, Oerlikon, Switzerland, CH-8050

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

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

More Information

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04537624
• Other Study ID Numbers: NN9924-4546; U1111-1240-4102 ( Other Identifier: World Health Organization (WHO) )
• First Posted: September 3, 2020
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

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

• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases