Over 114 million adults in the US live with diabetes or prediabetes, according to a 2017 report from the CDC. As of 2015, 30.3 million Americans have diabetes — 9.4% of the population. An additional 84.1 million adults have prediabetes, which often leads to type 2 diabetes within five years if not treated. 1.5 million people are newly diagnosed with diabetes every year.
Novo Nordisk (Copenhagen: Novo B; NYSE: NVO) announced today the topline results from PIONEER 2, its second phase 3a trial of oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analog taken once daily as a tablet. The 52-week, open label trial investigated the efficacy and safety of 14 mg oral semaglutide compared with 25 mg Jardiance (empagliflozin), marketed by Eli Lilly and Boehringer Ingelheim. The company tested the drug in 816 people with type 2 diabetes, who were inadequately controlled on metformin, and the confirmatory endpoints were defined after 26 weeks of treatment.
The company noted that two distinct statistical approaches to evaluating the effects of oral semaglutide were applied in this PIONEER 2 trial: a primary statistical approach required by recent regulatory guidance evaluating the effect regardless of discontinuation of treatment and use of rescue medication, and a secondary statistical approach describing the effect while on treatment and without use of rescue medication.
The trial achieved its primary objective according to the primary statistical approach, demonstrating a statistically significant and superior improvement in HbA1c levels with 14 mg oral semaglutide compared to 25 mg empagliflozin at 26 weeks. When applying the secondary statistical approach, people treated with 14 mg oral semaglutide achieved a statistically significant improvement in HbA1c of 1.4% at 26 weeks and 1.3% at 52 weeks, compared to 0.9% and 0.8% with 25 mg empagliflozin at 26 and 52 weeks, respectively.
The 14 mg dose of oral semaglutide demonstrated weight loss of 4.2 kg at 26 weeks and 4.7 kg at 52 weeks versus 3.8 kg with 25 mg empagliflozin at both 26 weeks and 52 weeks. The increased weight loss with oral semaglutide was statistically significant compared to empagliflozin at the 52-week time point, but not at the shorter 26-week point.
In addition, applying the secondary statistical approach, the American Diabetes Association treatment target of HbA1c below 7.0% was achieved by 72% of people treated with 14 mg oral semaglutide compared with just 47% of people treated with 25 mg empagliflozin at 52 weeks.
Erica Nishimura, PhD, Scientific Vice President of Diabetes & Obesity Pharmacology, Novo Nordisk.
As a measure of the demand for effective type 2 diabetes medication, Eli Lilly reported revenue from Jardiance in of $447.5 million in 2017 and $151.0 million in the 1st quarter of 2018. Mark Terry writes in Biospace that, according to analysts at Deutsche Bank, Novo Nordisk’s “oral semaglutide increasingly appears to be on its way to become a major blockbuster.”
We are very excited about these results, which demonstrate that people treated with 14 mg oral semaglutide for one year achieved statistically significant reductions in blood glucose and body weight compared to people treated with 25 mg empagliflozin. PIONEER 2 is an important milestone in the clinical development of oral semaglutide and we look forward to further understanding the clinical profile of oral semaglutide in the remaining PIONEER trials.
– Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer, Novo Nordisk.
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