4080 DEVOTE Degludec CV Outcome Study
Research type
Research Study
Full title
A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events
IRAS ID
139616
Contact name
Ponnusamy Saravanan
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-002371-17
ISRCTN Number
N/A
Research summary
The aim of this study is to confirm the long term effect of insulin degludec compared with insulin glargine on cardiovascular outcomes (such as heart attack and stroke) and other clinically important events.
Insulin degludec is marketed in the UK under the name of Tresiba® for the treatment of Type 2 diabetes. The study has been designed to address the requirements of the FDA prior to approval in the USA.
In this research study, patients are randomised to receive either insulin degludec or insulin glargine in addition to standard diabetes care.
Both insulin degludec and insulin glargine are liquids administered by subcutaneous (under the skin) injection and will be provided to patients in vials.
Approximately 7500 subjects with type 2 diabetes and at high risk of cardiovascular events will participate in this study. Subjects will be be enrolled from 20 countries in Europe, USA, South and Central America, South Africa and Asia. In the UK approximately 80 subjects will participate from 8 study sites.
Depending on when a subject enters the study they will receive study medication and be followed up for between 3.5 and 5 years. During this time they will attend up to 29 clinic visits. In addition there will be up to 35 phone contacts to check the subject's well-being and insulin adjustment levels.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0360
Date of REC Opinion
29 Jan 2014
REC opinion
Further Information Favourable Opinion