Extrait

Background and study aims Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Type 2 Diabetes can lead to a range of complications, including damage to the kidneys. It is known that maintaining normal blood sugar levels with drugs helps to slow the progression of kidney disease in diabetic patients. Hypoglycaemia is a term used to describe blood sugar levels that are too low. Hypoglycaemia is not always recognised by patients and is more common in patients with kidney disease who have had diabetes for a long time. Gliclazide is currently the most commonly used diabetic drug in the UK for patients with Type 2 Diabetes with kidney disease. Over the last ten years, a new class of diabetic drugs called Gliptins (including the drug Linagliptin) have become available which have been shown to cause less hypoglycaemia than Gliclazide. The aim of this study is to find out whether treatment with Linagliptin is safer and leads to fewer episodes of hypoglycaemia than Gliclazide, in patients with Type 2 Diabetes and moderate to severe long-term kidney disease. In addition, the study aims to find out how often unrecognised hypoglycaemic episodes occur in patients on Linagliptin compared to Gliclazide, whether Linagliptin is better than Gliclazide at protecting the kidney by mechanisms independent of just lowering blood sugar levels, and which of the two drugs makes patients feel better in themselves. Who can participate? Adults aged between 50 and 75 years who have had T2DM for at least 10 years, have moderate to severe long-term kidney disease, and are currently being treated with Gliclazide. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group continue taking their Gliclazide and those in the second group start taking Linagliptin instead. At the start of the study, participants in both groups have a device called a continuous glucose monitor (CGM) put in place to continuously monitor their blood sugar levels. This involves having a small sensor inserted under the skin, which measures blood sugar levels every 5 minutes over two seven day periods at the start of the study and then after eight weeks. During the two 7-day periods, patients are also asked to complete a food diary and obtain fingerprick sugar measurements using a home glucometer four times per day. Blood and urine samples are also collected at the start of the study and after eight weeks to measure biomarkers (natural indicators) that are associated with a decline in kidney function. Participants also complete a questionnaire to see how they are feeling. What are the possible benefits and risks of participating? Participants benefit from receiving their test results and explanations at the end of the study so they have more information about their diabetic control. There is a risk of minor bruising at the site where blood samples were taken, occasional minor bleeding and bruising when the CGM sensor is inserted under the skin, occasional irritation from the adhesive dressing used to secure the sensor to the skin, and occasional discomfort from the fitting and wearing of the CGM. Sometimes, the sensor may become dislodged and sound an alarm. Any changes to diabetic medication carries a small risk of affecting diabetic control, however, this will be closely monitored to minimise that risk. Where is the study run from? 1. Hammersmith Hosptial (UK) 2. St Mary's Hospital (UK) When is the study starting and how long is it expected to run for? August 2014 to July 2018 How long will the trial be recruiting participants for? Boehringer Ingelheim Ltd (UK) Who is the main contact? Mr Thomas Walters [email protected]

Critère d'inclusion

• Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter, Renal and Urogenital/ Other disorders of kidney and ureter

Liens

• isrctn