Oral semaglutide 25 mg and 50 mg demonstrate superior reductions in HbA1c and body weight versus 14 mg in people with type 2 diabetes in the PIONEER PLUS phase III trial- Novo Nordisk
Novo Nordisk announced headline results from the PIONEER PLUS trial, a phase IIIb, 68-week, efficacy and safety trial with once-daily oral semaglutide 25 mg and 50 mg versus 14 mg as add-on to a stable dose of 1–3 oral antidiabetic medicines in people with type 2 diabetes in need of treatment intensification.
The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 52 with both the 25 mg and 50 mg doses versus the 14 mg dose of oral semaglutide. When evaluating the effects of treatment taken as intended1 and from a mean baseline HbA1c of 9.0 %, people treated with 25 mg and 50 mg oral semaglutide achieved a statistically significant higher HbA1c reduction of 1.9 percentage points and 2.2 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg.
From a mean baseline body weight of 96.4 kg, people treated with oral semaglutide 25 mg and 50 mg experienced a statistically significant higher weight loss of 7.0 kg and 9.2 kg, respectively, compared with a reduction of 4.5 kg with oral semaglutide 14 mg.
When applying the treatment policy estimand, people treated with 25 mg and 50 mg oral semaglutide achieved a superior HbA1c reduction of 1.8 percentage points and 2.0 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg. People treated with oral semaglutide 25 mg and 50 mg experienced a superior weight loss of 6.7 kg and 8.0 kg, respectively, compared with a reduction of 4.4 kg with oral semaglutide 14 mg.
In the trial, all doses of oral semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Gastrointestinal adverse events were most prominent during dose escalation and more frequent with oral semaglutide 25 mg and 50 mg than with oral semaglutide 14 mg..
Novo Nordisk expects to file for regulatory approvals in the US and the EU in 2023. The global roll-out of the 25 mg and 50 mg doses is contingent on portfolio prioritisations and manufacturing capacity.
About the PIONEER clinical programme : The PIONEER clinical development programme for oral semaglutide currently comprises nine phase III global clinical trials, including a cardiovascular outcomes trial, involving more than 10,000 adults with type 2 diabetes in total.
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