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

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 Germany

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 34-44 weeks. Participants will be asked to complete questionnaires about how they take their Rybelsus® tablets. Participants will complete the questionnaires during their normally scheduled visit with the study doctor.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Oral Semaglutide

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Description

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 (<) 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated haemoglobin (HbA1c )	Percent-points.	From baseline (week 0) to End of Study visit (V3) (week 34-44)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Percent.	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Absolute change in body weight	Kilogram (Kg).	From baseline (week 0) to End of Study visit (V3) (week 34-44)
HbA1c <7% (Yes or No)	Percentage of patients achieving or not achieving HbA1c <7% (Yes or No).	End of Study visit (V3) (week 34-44)
HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No)	Percentage of patients achieving or not achieving HbA1c reduction >=1%-points and body weight reduction of >=5%.	From baseline (week 0) to End of Study visit (V3) (week 34-44)
HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No)	Percentage of patients achieving or not achieving HbA1c reduction >=1%-points and body weight reduction of >=3%.	From baseline (week 0) to End of Study visit (V3) (week 34-44)
Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction	The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.	End of Study visit (V3) (week 34-44)
Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction	The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items.	From baseline (week 0) to End of Study visit (V3) (week 34-44)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 30, 2022
• Primary Completion (ANTICIPATED): May 16, 2024
• Study Completion (ANTICIPATED): May 16, 2024

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (ACTUAL): July 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9924-4540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No