SIDS version
Research type
Research Study
Full title
The Effect of an SGLT2 inhibitor on Glucose Flux, Lipolysis and Ketogenesis following insulin withdrawal in people with absolute or relative endogenous insulin deficiency
IRAS ID
215268
Contact name
Melanie Davies
Contact email
Sponsor organisation
University of Leicester
Eudract number
2015-002094-38
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
SGLT2 inhibitors are a new class of drug currently prescribed as a glucose lowering treatment in people with type 2 diabetes. There is speculation that the drug may also be beneficial in people with type 1 diabetes to reduce the frequency of low blood glucose levels (<4.0mmol/L), reduce insulin requirements and help prevent weight gain.
However, case reports and early pilot clinical trials indicate that when SGLT2 inhibitors are prescribed in patients with known insulin deficiency they may be at risk of developing the potentially life threatening state of ketoacidosis in the presence of a normal glucose level. This condition can be very frightening and may need treatment in an intensive care unit.The concern is that people may not be aware they are developing the condition as the glucose level appears not to increase and the only sign is a rise in ketone levels. Unlike glucose levels, people do not routinely measure ketone levels.
The aim of this research is to develop an understanding of how SGLT2 inhibitors regulate blood glucose levels in periods of insulin deficiency, to ensure the class of drug will be safe for use in this patient group.
This is a metabolic study with people who have type 1 diabetes and people who are insulin deficient following pancreatic conditions. Participants will be required to attend two metabolic study visits and will receive in random order a placebo drug or SGLT2 inhibitor. During the metabolic study day, insulin will be withdrawn in a controlled manner and stable isotope tracers of glucose and glycerol will be given to monitor the amount of glucose produced and used by the body and the production of ketones, which are produced a fat is broken down for energy. Ketone and blood acid levels will be monitored very carefully throughout the study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0005
Date of REC Opinion
7 Feb 2017
REC opinion
Further Information Favourable Opinion