Low dosE GlibENclamide in Diabetes - Part A (LEGEND-A)
Research type
Research Study
Full title
Low-dose Glibenclamide in Type 2 Diabetes Mellitus - Part A (LEGEND-A)
IRAS ID
179317
Contact name
Ioannis Spiliotis
Contact email
Sponsor organisation
University of Oxford
Eudract number
2015-002837-23
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Diabetes is a chronic condition that affects 1 in 16 people in the UK, and leads to difficulty controlling blood sugar levels. This is due to an imbalance between two main hormones: insulin, which lowers blood sugar, and glucagon, which causes it to rise. Most current anti-diabetic medications work to improve insulin levels, however research is now shifting to better understand how glucagon levels play a key role in this disease.
Glibenclamide is a type of anti-diabetic medication (sulfonylurea) which is commonly used to increase the amount of insulin released by the pancreatic beta-cells. Studies in mice and human cells from donors with type 2 diabetes have shown that sulfonylureas can also improve glucagon levels when used in very small doses by working on different cells in the pancreas (alpha-cells).
The aim of this study is to find out whether low doses of glibenclamide can improve glucagon levels in patients with type 2 diabetes, and whether in the future this could be used to better control high blood sugar levels, without the risk of causing low blood sugar.
Participants with type 2 diabetes who are diet-controlled or on metformin will be given a liquid containing a low dose of glibenclamide. They will need to attend the OCDEM Clinical Research Unit at the Churchill Hospital, Oxford, for early morning blood tests every 3-4 days over a period of 3 weeks. A continuous glucose monitor will also be fitted during this time.
This study is funded by the NIHR OxBRC.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0202
Date of REC Opinion
3 May 2016
REC opinion
Further Information Favourable Opinion