A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in the United Kingdom, as Part of Local Clinical Practice

NCT04862923 | Completed

• 2 other identifiers: NN9924-4539U1111-1240-3705
• Study Type: observational
• Target: 336
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  percent-points

  From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Secondary Outcomes (7)

• Relative change in body weight

  From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

• Absolute change in body weight

  From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

• HbA1c less than 7 percent (Yes/No)

  End of Study visit (Visit 3) (week 34-44)

• HbA1c reduction greater than or equal to 1 percent-points and body weight reduction greater than or equal to 5 percent (Yes/No)

  From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

• HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)

  From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Study Arms (1)

Patients with type 2 diabetes

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

Drug: Oral semaglutide

Interventions

Oral semaglutide DRUG

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 treat the participant with a given product is independent of the decision to include him/her in the study.

Patients with type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 2 diabetes who are naïve to injectable glucose-lowering treatment

You may qualify if:

• 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 glycated haemoglobin (HbA1c) value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) 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 14 days or less.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Master Centre for United Kingdom

Gatwick, West Sussex, RH6 0PA, United Kingdom

Location

Related Publications (2)

• Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.

  PMID: 39316289 RESULT

• Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13.

  PMID: 39535683 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 1452

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: May 12, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)