Diabetes treatments on trial in China: the ACE study

'There is currently an explosion of diabetes taking place in China', says Professor Rury Holman, Director of Oxford's Diabetes Trials Unit DTU). He explains that worldwide, populations that have changed to more calorie-rich diets, perhaps as a result of increased material wealth, are experiencing corresponding increases in type 2 diabetes. A recent estimate put the figure at around 10 per cent of all adults in China: over 92 million people in total.

Diabetes is a major risk factor for heart disease and other causes of disability and premature death. For that reason it is essential to ensure that doctors are prescribing the most effective treatments for the people under their care, and yet until recently China had little tradition of conducting large-scale, randomised, controlled clinical trials. With Professor Holman as chief investigator, the DTU is collaborating with Professors Hu Dayi and Pan Chang Yu in Beijing to find out whether the commonly-used drug acarbose can help protect people in China with a history of heart disease, who are also at increased risk of diabetes, from further heart problems.

'Acarbose is a front-line drug for treating diabetes in China', says Professor Holman, 'and a previous trial has suggested that it might also reduce heart disease.' The drug helps to minimise the rise in glucose in the blood after meals, a measure that is an independent predictor of future heart disease. The ACE (Acarbose Cardiovascular Evaluation) trial is large enough to give a definitive answer to the question of whether acarbose does indeed reduce the risk of future heart attacks or strokes, and also whether it can reduce the risk of diabetes in this high-risk population. It began recruiting patients in 2008, and will run until 2017. To manage the 7,500 patients in 150 hospitals across China, the ACE trial has a coordinating centre in the newly-opened offices of the Oxford University Beijing Science and Technology Company Ltd in the heart of China's capital.

The DTU also runs two other international, multi-centre trials which will have sites in China, in collaboration with the US Duke Clinical Research Institute. These trials are investigating whether giving people with diabetes one of two new diabetes drugs, sitagliptin (the TECOS trial) and exenatide (the EXSCEL trial), alongside their usual diabetes care, makes them less likely to suffer from future heart attacks or strokes.

'China is well aware of the seriousness of the diabetes epidemic', says Professor Holman. 'The worry is that this could be an economic problem.' The outcome of these trials could have significance well beyond China, given that diabetes is a global problem, with large numbers of patients in India and the Middle East, as well as in industrialised countries such as the US, the UK and Australia.