Novo Nordisk’s oral semaglutide is gearing up to be quite the game changer for the GLP-1 class – which has long been dominated with injectables – and has been boosted by new results from its PIONEER programme.
Comparing oral semaglutide to Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin), PIONEER 7 investigated the efficacy and safety of the GLP-1 inhibitor in people with type 2 diabetes.
The trial specifically targeted a reduction in HbA1c – blood sugar levels – and oral semaglutide demonstrated that from a baseline HbA1c of 8.3%, 63% of people treated with Novo’s drug achieved the target HbA1c level – 7% or lower – compared to 28% of those treated with sitagliptin after 52 weeks of treatment.
Novo’s chief scientist officer Mads Krogsgaard Thomsen said: “With significant one-year results in a real-world dose setting, oral semaglutide was superior to sitagliptin by documenting a greater proportion of people achieving the HbA1c target level.”
The drug also hit the mark in the obesity setting, with patients achieving statistically significant and superior reductions in body weight versus sitagliptin.
A familiar story was told when oral semaglutide was compared with Novo’s best-selling diabetes blockbuster Victoza (liraglutide).
PIONEER 4 saw the enrolment of 711 people with type 2 diabetes inadequately controlled on metformin, or without an SGLT-2 inhibitor.
Like PIONEER 7, PIONEER 4 achieved its primary objective demonstrating a non-inferior reduction in HbA1c compared to Victoza (1.3% and 1.2% vs 1.1% and 0.9%) for weeks 26 and 52 respectively.
Reductions in body weight from a baseline was also reported at 26 and 52 weeks, and that trial compared oral semaglutide to both Victoza and placebo.
Patients achieved a 4.7 and 5.0kg loss compared to 3.2 and 3.1kg with Victoza and 0.7 and 1.2kg with placebo.
Novo is already a big player in the diabetes setting, with Victoza still gaining ground despite strong competition from Eli Lilly’s GLP-1 Trulicity (dulaglutide).
It could help Novo greatly expand its share of the diabetes market if the once-daily tablet gains approval, with its oral formulation helping it to be the first GLP-1 to bypass patients’ reluctance to use needles.