SINGLED
Research type
Research Study
Full title
The Effect of a SGLT2 inhibitor on Glucose flux, Lipolysis and Exercise in type 2 Diabetes
IRAS ID
217267
Contact name
Melanie Davies
Contact email
Sponsor organisation
University of Leicester
Eudract number
2016-004878-17
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Dapagliflozin is a new class of drug called a SGLT2 inhibitor that is taken once a day. The drug is beneficial in people with type 2 diabetes to reduce the frequency of low blood glucose levels, reduce insulin requirements and improve HbA1c.
However, there have been rare but significant observations that it may increase the risk of developing life-threatening episodes of diabetic ketoacidosis. This is of considerable worldwide interest and the underlying reason for ketone production is unclear.
Another important important observation is that it may reduce a persons risk of developing complications such a heart attack or stroke, again the mechanism for this is unknown.
The aim of this study is to look at the effect of a long term administration of SGLT2 inhibitors in people with Type 2 diabetes and look at the metabolic changes that take place to establish whether these contribute to the development of ketoacidosis and reduction of cardiovascular disease such as stroke or heart attack.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0184
Date of REC Opinion
26 Apr 2017
REC opinion
Further Information Favourable Opinion