Background

Diabetes
At least 180 million people worldwide suffer from diabetes and its incidence is increasing rapidly. The WHO estimates that more than 350 million people will suffer from diabetes in 2030. Based on its etiology, diabetes is categorized into two different types: type 1 diabetes (T1DM) characterized by a lack of insulin production due to autoimmune mediated destruction of the pancreatic β cells and representing 5-10% of all patients; and type 2 diabetes (T2DM) which accounts for approximately 90% of total DM prevalence and is typified by a progressive β-cell function decline in the presence of obesity-associated insulin resistance. Ongoing loss of insulin secretor capacity – along with diminished incretin effects – makes the hyperglycaemia of T2DM progressive, with a concomitant need for intensified therapy over time.

The different risks factors associated to T2DM make it particularly challenging to study the effects of drugs intended for the treatment.

Treatments
For decades insulin secretagogues and the insulin sensitizing biguanides have been the only oral therapeutic options available for the treatment of T2DM. Both drug classes have maintained good benefit-risk profiles throughout their life cycle.

In the quest for agents that could halt the progression of T2DM, several novel diabetes drugs have become available over the last decade, all on the basis of their ability to reduce blood glucose levels but with different mechanisms of action; and many more are on the pipeline.

All currently available drugs have been approved based on results from studies conducted according to existing regulatory guidelines. However, the requested relatively short-term studies may not suffice to fully reveal the consequences of long-term treatment. Especially for the newer products for which data regarding the long-term effects are very limited.