PROactive is a major clinical trial designed to investigate the effect of insulin resistance on cardiovascular morbidity and mortality in type 2 diabetes patients.

The PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive), jointly sponsored by Takeda and Lilly, enrolled over 5,000 patients in 19 European countries involving over 320 investigators.

The trial investigated whether ACTOS, the newest member of the thiazolidinedione (TZD) class of medications, can prevent the progression of macrovascular disease, which is associated with cardiovascular events such as myocardial infarction in type 2 diabetes patients. Type 2 diabetes affects an estimated 143 million people worldwide.

Previous clinical trials have demonstrated that controlling blood glucose levels, reducing high blood pressure and treatment with conventional therapies (such as sulphonylureas or insulin) can reduce the risk of microvascular events, such as damage to the kidneys, eyes and nerves in the hands and feet. However, such treatment does not appear to produce similar significant reductions in macrovascular events, such as heart attacks, strokes and amputation.

RESULTS

The PROactive Steering Committee presented the results at the plenary session of the 41st Annual Meeting of the European Association for the Study of Diabetes (EASD). If you were unable to attend, or could not get into the Hippocrates Hall (!), the webcast can be viewed by clicking here.

Slide presentations of stroke and MI prespecified analyses are available to download.

To view details of the study protocol (including amendments 1, 2, and 3) click here

To view the fourth amendment document please click here

To view the Statistical Analysis Plan (SAP) click here