Phase III trial results for NN 9535 (semaglutide subcutaneous) meets objectives and shows superiority over exenatide for type 2 diabetes- Novo Nordisk
Novo Nordisk announced headline results from the second phase IIIa trial for NN 9535 (semaglutide), SUSTAIN3, administered subcutaneously, once weekly. The trial investigated the efficacy and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide once-weekly after 56 weeks of treatment added on to 1–2 oral antidiabetic drugs in 813 people with type 2 diabetes.
The trial achieved its objective by demonstrating that from a mean baseline HbA1c of 8.4%, people treated with 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.5% compared to the improvement in HbA1c of 0.9% with 2.0 mg exenatide once-weekly. 66% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association and the European Association for the Study of Diabetes treatment target of HbA1c below 7% compared with 40% of the people treated with 2.0 mg exenatide once-weekly. Furthermore, from a mean baseline body weight of 96 kg, people treated with 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 5.6 kg compared with a weight loss of 1.8 kg for people treated with 2.0 mg exenatide once-weekly.
In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea which diminished over time. Nausea was reported by 22% of people treated with 1.0 mg semaglutide once-weekly compared with 11% of people treated with 2.0 mg exenatide once-weekly. The discontinuation rate due to all adverse events for 1.0 mg semaglutide was 9.4% compared to 7.2% for 2.0 mg exenatide.
Comment: In addition to the subcutaneous form, the oral daily version of Novo Nordisk's semaglutide (called OG 217SC) could impact radically on the GLP-1 market. Already, its Victoza (liraglutide) daily GLP-1 injection is market leading with $2 billion annual sales. The company's obesity treatment, Saxenda (liraglutide 3 mg), was recently approved (2014 in the USA and 2015 in the EU). But competition is coming from Eli Lilly which secured approval for the once-weekly Trulicity (dulaglutide) in 2014.
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