Results for Novo Nordisk’s semaglutide were reported today at the European Association for the Study of Diabetes. A filing for FDA approval is expected before the end of the year.
Novo Nordisk’s experimental type 2 diabetes (T2D) injection semaglutide cut cardiovascular (CV) by 26%, according to results of a large safety trial announced early today in Munich, Germany. Results were simultaneously published in New England Journal of Medicine.
The CV benefit comes entirely from semaglutide’s ability to reduce heart attacks and strokes; results showed no difference in death rates between those taking semaglutide and placebo. However, the data also showed a curious increase in complications from retinopathy among those using semaglutide, while rates of new or worsening nephropathy declined.
Results of the SUSTAIN-6 trial were presented at the meeting of the European Association for the Study of Diabetes. Semaglutide, a glucagon-like peptide-1 (GLP-1) analog given just once a week, is the third diabetes drug found to have a cardioprotective benefit since the FDA began requiring large CV outcomes trials after 2008. Another of Novo Nordisk’s GLP-1 drugs, liraglutide, was found to have a CV benefit earlier this year. The class works by stimulating insulin production when blood sugar rises.
Semaglutide’s less frequent dosing schedule—and the work to make it available in a daily pill form—make it one of the more promising T2D therapies under development. Novo Nordisk officials are expected to seek regulatory approval for the drug from FDA and in Europe by the end of 2016, according to Reuters. Novo Nordisk officials in Munich told Reuters that a longer, trial with 9000 patients was being planned, which would gather additional results on retinopathy complications.
The trial reported today involved 3297 patients with T2D who were randomly assigned to received either 0.5 mg or 1.0 mg doses of semaglutide, or 0.5 mg or 1.0 of a placebo, once a week. Patients were at least 50 years old with known CV disease or chronic kidney disease or at least 60 years old with 1 CV risk factor. All participants had glycated hemoglobin (A1C) of at least 7%. Outcomes of the trial included:
Earlier this year, at the American Diabetes Association meeting in June, researchers reported that semaglutide produced greater A1C reductions than sitagliptin at 56 weeks for patients taking the drug as with metformin and/or thiazolidinediones.
Phase 2 trials on oral semaglutide were reported in May at the annual meeting of the Endocrine Society. Researchers found the oral form’s effectiveness was on part with the injected form, but that higher doses might be required, which could affect the drug’s cost.
Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes [published online September 16, 2016]. N Engl J Med. DOI: 10.1056/NEJMoa160714.