SUSTAIN 8 and 10 Phase III trials of Ozempic show Ozempic superior in type 2 diabetes.- Novo Nordisk

Novo Nordisk announced the results from two Ozempic (once-weekly semaglutide 1.0 mg) head-to-head Phase III clinical trials, SUSTAIN 8 and SUSTAIN 10, which showed that Ozempic was superior to treatment with the SGLT-2 inhibitor canagliflozin (300 mg) in reducing HbA1c and body weight in people with type 2 diabetes uncontrolled on metformin. In addition, they showed that Ozempic was superior to Victoza (liraglutide 1.2 mg) in reducing HbA1c and body weight in people with type 2 diabetes. In SUSTAIN 8, at 52 weeks, Ozempic demonstrated a superior reduction in mean HbA1c of 1.5% compared to canagliflozin at 1.0%, from a baseline of 8.3%. In addition, 66.1% of people treated with Ozempic achieved HbA1c treatment target less than 7% vs 45.1% of those treated with canagliflozin. People treated with Ozempic also demonstrated superior reductions in body weight compared with canagliflozin with 5.3 kg vs 4.2 kg, respectively, from a mean baseline of 90.2 kg. Significantly more people treated with Ozempic achieved reduction in body weight of at least 10% vs canagliflozin (22.3% vs 8.9%, respectively).

In SUSTAIN 10, at 30 weeks, Ozempic demonstrated a superior reduction in mean HbA1c compared to Victoza (1.7% vs 1.0% respectively), from a mean baseline of 8.2%. In addition, 80% of people treated with Ozempic achieved HbA1c treatment target of less than 7% vs 46% of those treated with Victoza. People treated with Ozempic also demonstrated superior reductions in body weight compared with Victoza with 5.8 kg vs 1.9 kg, respectively, from a mean baseline of 96.9 kg. Significantly more people treated with Ozempic achieved reduction in body weight of at least 10% than those treated with Victoza (19% vs 4%, respectively).

The tolerability of once-weekly Ozempic was generally similar to that of Victoza and canagliflozin, except for higher rates of gastrointestinal adverse events (AEs) with Ozempic vs Victoza and more frequent infections and infestations with canagliflozin vs Ozempic. The safety profile of Ozempic 1.0 mg in both trials was consistent with the overall SUSTAIN clinical trial programme. These data were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in Barcelona, and simultaneously published in The Lancet Diabetes & Endocrinology (SUSTAIN 8) and Diabetes and Metabolism (SUSTAIN 10).

See: "Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, randomised, controlled trial." Lingvay I, et al. The Lancet Diabetes & Endocrinology. Published Online 17 September 2019. http://dx.doi.org/10.1016/PII

"Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1�3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10)." Capehorn MS, et al. Diabetes Metab (2019). https://doi.org/10.1016/j.diabet.2019.101117