PIONEER REAL - A Non-interventional Type-2 Diabetes Study
Research type
Research Study
Full 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 United Kingdom
IRAS ID
291357
Contact name
Ponnusamy Saravanan
Contact email
Sponsor organisation
Novo Nordisk Ltd
Duration of Study in the UK
1 years, 10 months, 4 days
Research summary
This is an observational (non-interventional) study investigating the use of a drug, oral semaglutide, in routine clinical practice. The decision to initiate treatment of oral semaglutide will be made by the patient's doctor according to their normal practice and is not mandated by the study protocol. The decision to initiate treatment of oral semaglutide will be made independently of the decision to include the patient in the study. Only patients already evaluated by doctors to be eligible for treatment with oral semaglutide can be included in the study.
Oral semaglutide is taken once-daily by patients with type 2 diabetes. Oral semaglutide was studied in the PIONEER clinical development program and was shown to improve glycaemic control and body weight in adults with type 2 diabetes when taken on its own or in combination with other antidiabetes medications.
This study aims to build upon the findings from the PIONEER program, by investigating how effective oral semaglutide is in the real-world setting when prescribed as per standard of care to adult patients with type 2 diabetes.
Oral semaglutide treatment will be managed and followed-up by the patient’s doctor as per their normal practice.This study is being sponsored by Novo Nordisk A/S and will be conducted in the UK at around 31 sites including both hospital sites and GP practices. It is planned that 381 patients will be enrolled. Individual participation will last approximately 34-44 weeks.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/PR/0266
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion