Novo Nordisk pushes forward with new diabetes drug trial
pharmafile | July 13, 2015 | News story | Research and Development | GLP-1 agonist, Novo Nordisk, diabetes, phase III, semaglutide, type 2 diabetes
Novo Nordisk is taking the first steps towards adding another type 2 diabetes drug to its portfolio, after announcing positive headline results of a Phase III trial of its investigational treatment semaglutide.
The latest offering in Novo’s type 2 diabetes stable is a glucagon-like peptide-1 (GLP-1) analogue that is given once-weekly. The Danish firm say it can help people with type 2 diabetes improve their blood sugar levels and lose weight.
The SUSTAIN1 study is a Phase IIIa trial of semaglutide 0.5 mg and 1.0 mg, when used as a monotherapy over 30 weeks, compared with placebo. It looked at 388 people with type 2 diabetes who were previously managing their condition by making changes to their diet and lifestyle.
The trial achieved its primary objective – by demonstrating that from a mean baseline HbA1c (a measure of blood sugar) of 8.1%, people treated with doses of 0.5 mg and 1.0 mg semaglutide achieved HbA1c levels of 1.5% and 1.6%, respectively, compared to no change in the placebo group.
Some 74% and 73% of the people on the 0.5 mg and 1.0 mg doses, respectively, achieved the clinical treatment target of HbA1c below 7%, compared with 25% of the placebo group.
And from a mean baseline of 92 kg, people treated with semaglutide 0.5 mg and 1.0 mg lost 3.8 kg and 4.6 kg, respectively, compared with 1.0 kg in the placebo group.
The most common adverse event was nausea. Overall some 5-6% of people on semaglutide stopped treatment because of side effects, compared with 2% for placebo.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, says: “We are excited about these results, which confirm that semaglutide has the potential to help people with type 2 diabetes achieve both good glycaemic control and a significant weight loss with one weekly injection.”
Novo Nordisk plans to announce headline results of another five semaglutide trials over the next nine months. Industry analysts have predicted the drug could be a ‘game-changer’ for Novo Nordisk – particularly as the firm is also developing an oral version of the drug, called OG217SC, which has performed well in Phase II trials.
An oral option could radically change the blockbuster GLP-1 market, and extend Novo’s dominance of the market. The firm’s daily GLP-1 injection Victoza, leads the market with $2 billion in annual sales, and Novo won approval in the EU in March and in the US in 2014 for a higher-dose version of Saxenda as a treatment for obesity.
Lilian Anekwe
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