The past year demonstrated how developing pharmacological solutions for better ways of insulin substitution and making those drugs commercially available for patients with all forms of diabetes are becoming more and more complex issues worldwide in the light of increasing patient numbers and rising health-care costs. Meanwhile, the two first rapid-acting analogs are celebrating their 20th (insulin lispro) and 15th (insulin aspart) anniversaries of commercial approval. The discussion on the long-term safety concerns of insulin analogs has quieted down considerably and only further reassuring data regarding mitogenicity have become available lately. In 2013 the U.S. Food and Drug Administration (FDA) had requested additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Application for the long-acting insulin degludec could be completed. Degludec had received marketing authorization valid throughout the European Union (EU) and other countries already early 2013. In September 2015, the FDA approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) after reassuring data from the DEVOTE trial
