Considerable progress has been made on our way toward optimal treatment of patients with diabetes mellitus (DM), and many insulin therapy strategies are now available for these patients. We will see further improvements in insulin therapy, and there is hope for a cure in the not too distant future. All of these developments, however, depend on the willingness of the health care and economic systems to fund these new advances. The major burden of this disease is the treatment of DM-related late complications, yet an increased investment in the quality of metabolic control can result in a reduced incidence of these complications. The future of new insulin formulations or new types of insulin applications depends very much on the performance of adequate clinical trials to prove the benefits of such innovations. It requires an open discussion involving all relevant parties, including patients, about the types of clinical studies that are required.