New drug reduces risk of death in patients with type 2 diabetes

In Germany, about one in ten people suffer from diabetes. Diabetes patients still die two to three times more frequently from cardiovascular diseases such as heart attacks and strokes. Newly developed drugs for diabetes therapy are expected to reduce the number of cardiovascular deaths: Scientists from the Paul Langerhans Institute Dresden (PLID) at the Medical Faculty of the TU Dresden, partners in the German Center for Diabetes Research (DZD), have, together with international colleagues, investigated for the first time whether semaglutide in tablet form leads to a reduction in cardiovascular events. An international, randomized double-blind study with 3,183 participants was therefore conducted in 21 countries in parallel. The results of the so-called PIONEER-6 study have now been published in the renowned journal 'New England Journal of Medicine (NJEM)'.

Prof. Dr. Andreas Birkenfeld. Source: Nutzwerk, Thomas Kretschel

In recent years, so-called incretin analogues have been developed, which act like the intestinal hormone GLP-1. These drugs lead to the release of insulin in the beta cells of the pancreas and at the same time reduce the feeling of hunger in the brain. Due to their chemical structure, these substances have to be administered by subcutaneous injection and therefore cannot be taken orally as tablets. A large international study (SUSTAIN-6 study) has already shown that the active ingredient semaglutide leads to a reduction in cardiovascular events, especially strokes, when administered subcutaneously and recently researchers succeeded to make the GLP-1 receptor agonist semaglutide available as a tablet by combining it with an absorption enhancer.

In the PIONEER-6 study, people with type 2 diabetes were examined at various centers worldwide. Thereby, the subjects received either a tablet with semaglutide or a placebo in addition to their respective standard diabetes therapy. "At the end of the study period, we found that the treatment with oral semaglutide did not formally lead to a difference in the primary endpoint, such as cardiovascular death, non-fatal stroke and non-fatal myocardial infarction. However, a 51 % reduction in the risk of cardiovascular death and a 49 % reduction in the risk of death for any reason were observed in patients taking oral semaglutide," explains Prof. Dr. Andreas Birkenfeld, co-author of the study from the University Study Center of Metabolic Disease at the University Hospital Dresden and research group leader at the Paul Langerhans Institute Dresden of Helmholtz Zentrum München at the University Hospital and Faculty of Medicine Carl Gustav Carus of TU Dresden. "In addition, the semaglutid pill led to an average weight loss of 4.2 kg and a better blood sugar control.” These results are now being expanded in the even larger, international SOUL study. Novo Nordisk is currently applying to the relevant authorities for approval of the semaglutide tablet for the treatment of type 2 diabetes.

Original publication:
Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, Thomsen M, Vilsbøll T, Warren ML, Bain SC; PIONEER 6 Investigators. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2019 Jun 11. doi: 10.1056/NEJMoa1901118. [Epub ahead of print]

The study was funded by Novo Nordisk.