Novo Nordisk’s oral diabetes drug semaglutide is bearing down on one of its rivals — outperforming Jardiance (empagliflozin) in a Phase IIIa trial that could set Novo up to snatch more of the type 2 diabetes market.
Semaglutide, first approved as an injectable by the FDA late last year under the brand name Ozempic, falls in the blockbuster class of drugs known as GLP-1s. This latest trial, called Pioneer 2, put an oral version of the drug up against Boehringer Ingelheim and Eli Lilly’s Jardiance, an oral SGLT2-inhibitor approved back in late 2016. The study primarily looked at how Novo’s pill compared at influencing levels of glycated haemoglobin (HbA1c), an important measure for drugmakers hoping to lower the risk of heart failure and other complications associated with high blood sugar over time.
The 52-week, open label trial tested 14 mg of Novo’s drug semaglutide compared with 25 mg of empagliflozin in 816 people with type 2 diabetes. The trial nailed its primary endpoint, with semaglutide demonstrating a statistically significant and superior improvement in HbA1c compared to empagliflozin. Novo made a point to note that they measured the data in two ways: (1) a primary statistical approach (required by regulators) that evaluated the drug’s effect regardless of whether patients discontinued the treatment or had to use “rescue” medications” during the trial; (2) describing the effect while on treatment and without the use of rescue meds.
When measuring the data the primary way, the drug failed to hit one of its secondary outcomes: weight loss, a new market opportunity Novo hoped to tap. But when applying their secondary approach to analysis, Novo reported the 14 mg dose demonstrated weight loss of 4.7 kg at 52 weeks compared to 3.8 kg when on empagliflozin for the same period.
Also when applying the secondary statistical approach, 72% of people treated with semaglutide hit the American Diabetes Association target of HbA1c below 7% , while only 47% of patients on empagliflozin hit this target.
In the trial, oral semaglutide was well-tolerated and had a safety profile consistent with GLP-1-based therapy. Notably, though, the proportion of patients who quit treatment due to adverse events was 11% on semaglutide, compared with only 4% on 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, Novo’s chief science officer, said in a statement.
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