GLOOCOSE
Research type
Research Study
Full title
A randomised controlled trial of the sulfonylurea Gliclazide and the DPP4 inhibitor Linagliptin on the frequency of hypoglycaemia among patients with Type 2 Diabetes and chronic kidney disease (CKD) stage 3b and 4.
IRAS ID
164059
Contact name
Andrew Frankel
Contact email
Sponsor organisation
Clinical Trials Manager, AHSC Joint Research Compliance Office
Eudract number
2015-002309-12
Research summary
Low blood glucose levels, otherwise known as hypoglycaemia, is a common and potentially life threatening side effect of the sulphonylurea class of drugs used to treat type 2 diabetes. Subjects with type 2 diabetes and kidney disease are particularly prone to hypoglycaemia and this is often unrecognised. The main purpose of the study is to assess if the diabetic drug Linagliptin that belongs to a new class of diabetic drugs that is not a sulphonylurea is associated with fewer episodes of hypoglycaemia than the UK's most commonly used diabetic drug for type 2 diabetic kidney disease Glicazide that is a sulphonylurea. The study will use a device called a continuous glucose monitor (CGM) to record glucose levels of up to seven days. This monitor captures 288 glucose readings per day and the results can be downloaded onto a computer identifying episodes of hypoglycaemia that occur during the day and night.
The study will also assess whether the drug, Linagliptin has any other advantages over Gliclazide for the treatment of subjects with type 2 diabetes, with mild to moderate kidney disease, by looking at markers in the blood and urine that are associated with deteriorating kidney function.
Finally, using the validated Diabetes Treatment Satisfaction Questionnaire (DTSQ), the study will assess whether patients feel better when taking Linagliptin or Gliclazide.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/1548
Date of REC Opinion
30 Nov 2015
REC opinion
Further Information Favourable Opinion