Extrait

Background and study aims Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels 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). According to the 2015 Internation Diabetes Federation estimates, there are 35.4 Million people with type 2 diabetes mellitus in the MENA (Middle East and North Africa) region with an estimated rise to up to 72.1 million by 2040. Diabetes-related deaths stand at a staggering 342,000 during 2015, with over half of all deaths from diabetes in the region occurring in people under 60. A major issue that is dealt with by diabetologists, especially with patients with a rural background, is poor compliance with medication and dietary advice. Furthermore, the characteristics of the diabetic Asian population are unique, in the sense that as compared to western counterparts, Asians tend to have lower BMIs, a younger onset of type 2 diabetes, a high carbohydrate diet, high blood sugar levels after meals, and a more marked problem with insulin production. Standard treatment for T2DM involves treatment with a drug called metformin. DPP4 inhibitor is another drug which helps the body to produce more insulin. The aim of this study is to assess blood sugar control in newly diabetic patients treated wit DPP4 inhibitor and metformin to treatment with metformin alone. Who can participate? Adults who have been newly diagnosed with T2DM. What does the study involve? Participants are randomly allocated to receive either a single initial drug (as current guidelines recommend), or a combination of two drugs (in a single pill). They are then monitored at intervals of three months, as is the standard procedure for people with type 2 diabetes, and blood tests are performed at the regular intervals to assess their blood sugar control. If, at any of their scheduled visits, it was found that their diabetes control was not up to standard, an additional drug is added after thorough patient education. Visits thereafter are at the scheduled three month intervals, or earlier if the patient desires. A line of communication always remains open, allowing the patients direct access to their doctors. Participants attend regular clinic appointments over a period of five years to assess how well they are managing their diabetes. What are the possible benefits and risks of participating? The direct benefits were availability of the drugs with no cost to the patient, scheduled visits with consultants, and direct access to a doctor if and when desired by the patient. Since no new drugs are being tested, and the treatment being used is well established, there were no unforseen risks to the participants other than those normally encountered by diabetics taking regular medication. Where is the study run from? Pakistan Institute of Medical Sciences (Pakistan) When is the study starting and how long is it expected to run for? June 2009 to July 2016 Who is funding the study? Investigator initiated and funded (Pakistan) Who is the main contact? 1. Dr Mohammad Ali Arif (public) 2. Professor Rauf Niazi (scientific)

Critère d'inclusion

• Type 2 diabetes mellitus

Liens

• isrctn