BAGSVÆRD, Denmark, Sept. 17, 2019 /PRNewswire/ — Novo Nordisk announced today the results from two Ozempic® (once-weekly semaglutide 1.0 mg) head-to-head Phase 3 clinical trials, SUSTAIN 8 and SUSTAIN 10, which showed:
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.1
Ozempic® was superior to Victoza® (liraglutide 1.2 mg) in reducing HbA1c and body weight in people with type 2 diabetes.2
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).1,2
"We are proud of the superior clinical profile of once-weekly Ozempic®, as demonstrated through all the SUSTAIN clinical trials, and encouraged by these new data which further reinforce the value of Ozempic® for people with type 2 diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
These trials form part of the extensive SUSTAIN programme, a global clinical development programme that comprises more than 10 Phase 3 trials involving more than 10,065 adults with type 2 diabetes. To date, outcomes of SUSTAIN 1-7 and 9 have been published demonstrating Ozempic® is a best-in-class, efficacious and well-tolerated treatment option for people with type 2 diabetes.
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 <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 ≥10% vs canagliflozin (22.3% vs 8.9%, respectively).
"To date, head-to-head trials of GLP-1 receptor agonists and SGLT-2 inhibitors have been limited," said Dr Ildiko Lingvay, University of Texas Southwestern Medical Centre, Dallas, and lead study investigator. "These data seen in the SUSTAIN 8 trial support Ozempic® as an efficacious treatment option for reducing blood sugar and body weight for people with type 2 diabetes after metformin."
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 <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 ≥10% than those treated with Victoza® (19% vs 4%, respectively).
"Intensifying treatment with Ozempic® showed significant benefits over Victoza® in terms of blood sugar control and reduction in body weight, providing an alternative treatment option for those uncontrolled on current treatment," said Dr Matthew Capehorn, Rotherham Institute for Obesity, UK, and lead study investigator.
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.
Once-weekly Ozempic® (semaglutide) is an analogue of human glucagon-like peptide-1 (GLP-1) indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.3,4 Ozempic® was first approved by the US FDA in 2017 and is now launched in 25 countries.
About SUSTAIN 8
SUSTAIN 8 is a 52-week double-blinded Phase 3 trial investigating the efficacy and safety of once-weekly Ozempic® (semaglutide 1.0 mg) vs canagliflozin 300 mg as add-on to metformin in people with type 2 diabetes. The primary endpoint was change in HbA1c from baseline to Week 52, and key secondary endpoints include change in body weight at Week 52 and proportion of people achieving HbA1c <7.0% (53 mmol/mol) at Week 52.1
About SUSTAIN 10
SUSTAIN 10 is a 30-week open-label Phase 3b trial investigating the safety and efficacy of Ozempic® 1.0 mg once-weekly vs Victoza® 1.2 mg once-daily, as add-on to 1–3 oral antidiabetics (OADs) in 577 adults with type 2 diabetes in Europe. The primary endpoint was change in HbA1c at Week 30, and key secondary endpoints include change in body weight at Week 30 and proportion of people achieving HbA1c <7.0% (53 mmol/mol) at Week 30.2
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 80 countries and markets its products in more than 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Lingvay I, et al. 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. The Lancet Diabetes & Endocrinology. Published Online 17 September 2019. http://dx.doi.org/10.1016/PII
Capehorn MS, et al. 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). Diabetes Metab (2019). https://doi.org/10.1016/j.diabet.2019.101117
EMA. Ozempic® Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004174/WC500244163.pdf. Last accessed: September 2019.
FDA. Ozempic® US Prescribing Information. December 2017. Available at: http://www.novo-pi.com/ozempic.pdf Last accessed: September 2019.
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