Novo Nordisk has reported positive results from the Phase IIIa PIONEER clinical trial programme of oral semaglutide to treat type 2 diabetes patients.
According to the data from an exploratory analysis of the programme, 3mg, 7mg and 14mg doses of the drug led to glycaemic control in patients across baseline HbA1c levels.
However, the 7mg and 14mg doses showed higher HbA1c reductions compared to Jardiance (empagliflozin), Januvia (sitagliptin), Victoza (liraglutide) or placebo.
Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue formulated as a pill for once-daily use.
The oral formulation was assessed in a total of 9,543 type 2 diabetes patients enrolled across ten trials under the PIONEER programme.
In the exploratory analysis, findings from 5,657 patients in the PIONEER 1-5, 7 and 8 trials were grouped by study based on baseline HbA1c.
PIONEER 1 compared oral semaglutide with diet and exercise, while PIONEER 2 compared the investigational drug with 25mg empagliflozin and PIONEER 4 with 1.8mg liraglutide.
During the PIONEER 3 and 7 studies, oral semaglutide was assessed against 100mg sitagliptin, and PIONEER 8 involved evaluation as an add-on to insulin.
The proportion of patients reaching an HbA1c target of <7% was observed to be higher with 7mg and 14mg oral semaglutide versus all comparators across all HbA1c baseline subgroups.
The safety profile of oral semaglutide across the programme was also found to be consistent with the GLP-1 receptor agonist class and similar to that of subcutaneous semaglutide.
Novo Nordisk executive vice-president and chief science officer Mads Krogsgaard Thomsen said: “This analysis reinforces the findings seen throughout the PIONEER trial programme, demonstrating oral semaglutide’s efficacy in HbA1c reductions compared to commonly used type 2 diabetes treatments.
“If approved, oral semaglutide will become the first and only oral GLP-1 receptor agonist with the potential to help people with uncontrolled type 2 diabetes better manage their condition.”
An injection form of semaglutide is indicated to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet and exercise.