A new outcome trial, sponsored by Bayer HealthCare, will commence in 2007 and investigate the effects of the oral antidiabetes drug, acarbose (Glucobay®, Bayer HealthCare AG), on preventing recurrent cardiovascular disease (CVD) and type 2 diabetes in individuals with CVD and prediabetes. Details were announced by the co-chairmen of the independent research group at the International Diabetes Federation’s 19th World Diabetes Congress held in Cape Town. A web-cast of the BHC symposium is available at www.diabetes-symposium.org.

Trial to measure secondary prevention of CVD and diabetes

The Euro Heart Survey and China Heart Survey have established the close relationship between coronary heart disease and dysglycaemia. As a result of these and other data, the recent joint European Society of Cardiology (ESC) and European Association for the Study of Diabetes (EASD) guideline on dysglycaemia and CVD encourages closer collaboration between diabetologists and cardiologists to improve the diagnosis and management of both diseases. The guideline recommends early and direct intervention to prevent CVD and diabetes once prediabetes has been confirmed by an oral glucose tolerance test.

The new outcome trial with acarbose will have a randomised, placebo-controlled design, recruiting approximately 6,500 individuals with CVD who also have prediabetes from approximately 70 specialist centres in China and Hong Kong.

In some countries acarbose is available as Prandase® or Glucor®. Patients will receive acarbose or matching placebo for a minimum of 3 years in addition to optimised CVD management. The trial will assess, as the primary endpoint, the effect of acarbose on the occurrence of new cardiovascular events (secondary CVD prevention). It will also assess the occurrence of new-onset type 2 diabetes (primary diabetes prevention) as a secondary endpoint. Final trial results are expected in 2012.

This new outcome trial will be co-chaired by Professor Rury Holman (University of Oxford Diabetes Trials Unit, UK) and Professor Pan Chang-Yu (University of Beijing, China). The trial will be coordinated by the University of Oxford Diabetes Trials Unit, which will set up a project office in China. The trial will be sponsored by Bayer HealthCare.

"This trial, conducted in an academic collaboration with Bayer HealthCare, provides an important opportunity to confirm the cardiovascular findings of STOP-NIDDM. Although the trial will be conducted in China and Hong Kong, its findings will be of relevance worldwide", commented Professor Holman.

It is anticipated that the new trial will support and extend the findings of the Study to Prevent Non-Insulin Dependent Diabetes Mellitus (STOP-NIDDM). This randomised, placebo-controlled trial in Europe and North America found that acarbose significantly reduced the risk of progressing from prediabetes to type 2 diabetes by 36% (primary diabetes prevention), and significantly lowered the risk of a first cardiovascular event by 49% (primary CVD prevention), including a 91% reduction in the risk of myocardial infarction (MI).

Patients with CVD and prediabetes will be selected

Individuals must be at least 50 years old to be included in the trial, have confirmed CVD (MI, as well as stable and unstable angina) and be shown to have impaired glucose tolerance (IGT). Patients will be excluded from the trial if they have a previous history of type 2 diabetes, have suffered a cardiovascular event within the previous 3 months, or have undergone or plan to have cardiovascular surgery. Patients will receive international standard-of-care therapy for their existing CVD during the trial, and will attend regular visits at which physiological and safety parameters will be checked.

Extending the prevention profile of acarbose

Acarbose is the only oral antidiabetes drug currently approved for the treatment of prediabetes, and has been prescribed for this use in China since 2002. A typical ‘start low, go slow’ dose titration regimen will be used in the trial to optimise acarbose treatment. Patients will initially receive acarbose 50 mg or matching placebo once daily, with the dosage increasing gradually to a maximum of 50 mg three times daily.

“This trial marks a new milestone in our knowledge of acarbose as an important treatment for the primary prevention of type 2 diabetes and a possible option for the secondary prevention of CVD”, concluded Helmut Schaefers, Corporate Communications Bayer HealthCare AG.


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