LINDA-CKD
Research type
Research Study
Full title
Linagliptin in Type 2 Diabetes and Chronic Kidney Disease (CKD) - An observational study of safety and efficacy using Continuous Glucose Monitoring (CGM).
IRAS ID
228866
Contact name
Hsiu Lye Yap
Contact email
Sponsor organisation
Imperial College London, Joint Research Compliance Office
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
The LINDA-CKD study is an observational study looking at patients with Type 2 Diabetes and chronic kidney disease. Diabetic kidney disease remains the commonest cause of end stage kidney failure in the UK. Achieving good diabetes control limits the progression of kidney disease but this needs to be balanced against the risk of overly low blood sugar levels, also known as hypoglycaemia. Hypoglycaemia has been linked with increased disease burden and death, and also affects patients’ quality of life. In addition, several classes of drugs need dose adjustments or cannot be given in patients with chronic kidney disease, therefore limiting treatment options. Linagliptin is a drug for diabetes that can be taken by patients with chronic kidney disease, including those on dialysis. \n\nWe will be studying patients with Type 2 diabetes who have chronic kidney disease (including those on dialysis) who are already taking Linagliptin. We are also studying similar patients who are not taking Linagliptin as this would form the comparison group. We will not be starting or changing any treatments. We want to know if:\n1) Patients taking Linagliptin for their diabetes have fewer episodes of hypoglycaemia compared to patients who are not taking Linagliptin; and if\n2) Linagliptin has an additional protective effect on the kidneys, and whether this effect is maintained over time. \n\nTo answer these questions, we will be putting a continuous glucose monitor (CGM) on the participant for 1 week to detect any episodes of hypoglycaemia. During this time, participants will need to do fingerpick blood sugar testing and complete a food diary. We will also obtain blood and urine samples to measure the levels of kidney biomarkers. \nThe study will be conducted at Hammersmith Hospital as part of Imperial Healthcare NHS Trust, and there will be 2 study visits over 1 week.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
17/LO/2083
Date of REC Opinion
19 Dec 2017
REC opinion
Favourable Opinion