Extrait

Background and study aims Cardiologists use tests such as dobutamine stress echocardiography to look at the effect of narrowings of the coronary arteries on heart muscle function. We know that factors other than the severity of the narrowings can alter individual responses during the test. Sitagliptin is a tablet used for the treatment of diabetes and we have previously shown that a single dose of the tablet can produce an improvement in heart muscle function during dobutamine stress echocardiography. We are now interested in finding out whether giving sitagliptin for a longer period can produce a long term benefit. Who can participate? We are inviting patients who have type 2 diabetes and have had angina or other evidence of narrowings in the coronary arteries. What does the study involve? Patients will be invited to attend for two visits. For both they will have fasted from the night before. On the first visit we will perform a standard stress echo during an intravenous infusion of a drug called dobutamine, which will steadily increase the heart rate, in a similar fashion to exercising. Patients will have their heart rate and blood pressure monitored throughout. This visit will take about 2 hours. We will then ask patients to take the study medication, sitagliptin, once daily for 4 weeks. After this 4 week period, patients will be asked to attend for the second visit when we will repeat the tests done on the first visit. This visit will also last about 2 hours. The first scan assesses the function of the heart under normal metabolic conditions. The second scan assess the heart under the altered metabolic conditions and the two are later compared and analysed. What are the benefits and risks of participating? The study drug, sitagliptin, is a fully licensed drug in use in the UK for the treatment of diabetes. It is therefore safe, and significant side effects are rare. These include nausea (<10%), somnolence (<1%), upper abdominal pain (<1%) and diarrhoea (<1%). Unlike several other diabetes medications, the risk of a low blood sugar after taking the tablet is very low. There are no serious interactions with any other medications. We cannot promise that the study will help patients but the results will advance our understanding of coronary artery disease (narrowings) and diabetes, and direct the search for better treatments for it in the future. We believe that the risks are small. The stress echo scan has been performed safely for many years using the same drugs and setup that we plan to use. During the scan patients may experience some angina (although not usually as much as on a treadmill test) or light-headedness. Some patients feel nauseated and sweaty. These are usually short lasting and stop once the drug is switched off. If necessary, the scan can be stopped at any time. In rare cases the heart rhythm becomes abnormal. This usually corrects itself. The risk of a serious complication is less than 1 in 500. Where is the study run from? The Clinical Research Facility at the Addenbrooke's Centre for Clinical Investigation in Cambridge (UK). When is the study starting and how long is it expected to run for? The study started in February 2011 and is to run for approximately 2 years. Who is funding the study? The study has been funded by the Medical Research Council (London, UK) and supported in part by the Investigator-Initiated Studies Program at Merck. Who is the main contact? Dr David Dutka [email protected]

Critère d'inclusion

• Type 2 Diabetes Mellitus
• Coronary Artery Disease

Liens

• ictrp
• isrctn