NN9068-4264 Retrospective study_Xultophy in Adult T2 Diabetes
Research type
Research Study
Full title
A European multi-centre, retrospective, non-interventional study of the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus
IRAS ID
203882
Contact name
Adie Viljoen
Contact email
Sponsor organisation
Novo Nordisk A/S
Duration of Study in the UK
0 years, 6 months, 26 days
Research summary
Type 2 diabetes mellitus (T2DM) is a progressive disease that can affect or bring on functional changes to multiple organs throughout the lifetime of a patient. This requires a multi-targeted approach to treatment. Accordingly, there is a need for therapies that have complementary mechanisms of action to help achieve improved glycaemic control with fewer side effects than the currently available treatment options. In Europe, 52 million individuals had diabetes in 2014; and that number is expected to reach 68.9 million by 2035. Although progress has been made in the management of T2DM in Europe, the lack of attainment of appropriate glycaemic targets remains a problem for many T2DM patients.
Widely used guidelines recommend haemoglobin A1c (HbA1c) targets of <7.0%-<7.5% or within 6.5-7.5% for individualised targets. Xultophy® (IDegLira) is the first basal insulin (insulin degludec; IDeg) and GLP-1 RA (liraglutide) fixed ratio co-formulation in one pen.
Efficacy of Xultophy® has been established through randomised controlled trials and it received its marketing authorisation in September 2014 in the EU but there is a need to determine the effectiveness of Xultophy® in routine clinical practice and in a non-selected population.
This study aims to evaluate the clinical effectiveness of Xultophy® and the associated health care resource utilisation in adult T2DM patients treated at several outpatient clinics in Austria, Germany, Switzerland, Sweden, and the UK. There will be a total of 680 patients, of which 40 patients will be consented in the UK.
The study does not involve any clinical interventions. It will just collect information on up to 18 months of medical history for each patient.REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0158
Date of REC Opinion
15 Jun 2016
REC opinion
Further Information Favourable Opinion