A cardiovascular outcomes trial has already shown a reduction in cardiovascular events, but not deaths.
Novo Nordisk’s once-weekly semaglutide has outperformed another weekly therapy, dulaglutide, in controlling blood glucose and helping patients with type 2 diabetes (T2D) lose weight. The drug also overcame concerns about retinopathy that appeared in an earlier trial. The company reported results from the SUSTAIN 7 trial in a statement late Wednesday.
The 40-week trial compared safety and efficacy of the smaller and larger doses of the 2 drugs head-to-head. The semaglutide doses are 0.5 mg and 1.0 mg and the dulaglutide doses are 0.75 mg and 1.5 mg; all doses were added to metformin. Dulaglutide, sold as Trulicity by Eli Lilly, was approved in September 2014.
Trial results showed:
Among the patients, 44% of those taking 0.5 mg semaglutide and 63% taking 1.0 mg semaglutide achieved 5% weight loss, compared with 23% and 30% for the smaller and larger doses of dulaglutide. Guidelines for CDC’s Diabetes Prevention Program call a 5% weight loss or greater “transformational,” which means significant health benefits occur.
Semaglutide, the next entrant in the powerful class of glucagon-like-1 (GLP-1) receptor agonists, is under review by FDA and European regulators. Novo Nordisk has already reported results from a cardiovascular outcomes trial that show the drug cut cardiovascular events by 26%, although not deaths. That trial showed a slight uptick in retinopathy, but the new trial did not show any disparity in these events with dulaglutide.