The study seeks to uncover 'data blind spots' in Africa and emerging markets, just as in developed countries where data is more available. AstraZeneca South Africa is participating in the NIS and, as one of the 40 participating countries, has a goal of recruiting 500 patients across 20 sites by 31 December 2015.
The study will provide a worldwide view of the characteristics of diabetes patients and their treatment, disease management patterns and the clinical evolution of treatment of type 2 diabetes, the successes, gaps and critical steps to be taken to reduce the public health threat of this disease.
Clinical practices and hospitals have been selected to be representative of type 2 diabetes management in each participating country. The group hopes that ultimately the study will facilitate a change in the treatment paradigm for diabetes patients.
According to Dr Jasvanti Bhana, AstraZeneca South Africa VP for Medical and Regulatory Affairs, the study aims to understand how patients with type 2 diabetes are treated in clinical settings and in so doing, better understand the challenges facing both healthcare givers and patients with type 2 diabetes.
In many countries, particularly in Africa, there is a lack of evidence in diabetes and clinical outcomes remain scarce or incomplete. Further, despite the robust growth in how many medications there are for the treatment of diabetes, some of the newer agents actually have very little data in terms of how they are used and the patients' outcomes.
"Minimal information has been captured and published on newer classes of type 2 diabetes therapies. The study will yield data that has never been captured in other studies and will allow for scientifically meaningful discussions with physicians, prescribers and payers," says Bhana.
It is also capturing data in an innovative way. By combining prospective assessment, with electronic health records, and providing an opportunity to validate patient-reported outcomes against clinical data in a large patient population, the results are expected to be far more comprehensive and valuable.
"More than just a clinical study, we are going to get information about characteristics of diabetes patients across the world, information about their medical history and about their comorbidities. We are going to get insight about how patients are being treated in reality, how the disease evolves with time and, most importantly, what can be done to improve the situation of these patients. The study is a reflection of the need for additional real world evidence to support enhanced understanding of how diabetes is managed," concludes Bhana.
There are 387 million people with diabetes worldwide, according to the International Diabetes Federation (IDF). Diabetes causes five million deaths annually and threatens to derail economic stability due to the billions lost in productivity and healthcare costs. The IDF also predicts that there may be almost 600 million people living with diabetes by 2035.
