30 Mar 2023 • The investigational 25mg and 50mg oral doses of semaglutide led to superior reductions in HbA1c and weight loss among patients with type 2 diabetes in need of therapy intensification vs the 14mg dose of semaglutide, according to results from the phase 3b PIONEER PLUS trial.

More about the PIONEER PLUS trial:

• The PIONEER PLUS trial included over 1200 patients 18 years of age and older with type 2 diabetes who were currently on a stable dose of 1 to 3 oral antidiabetic medications (eg, metformin, sulfonylureas, and/or SGLT2 inhibitors)
• Patients had a mean baseline HbA1c of 9.0% and a mean baseline body weight of 96.4kg.
• The study participants were randomly assigned to receive semaglutide 25mg, 50mg, or 14mg orally once daily for 68 weeks.
• According to the trial product estimand, patients treated with the 25mg and 50mg doses achieved statistically significant and superior HbA1c reductions of 1.9 and 2.2 percentage points, respectively, compared with a reduction of 1.5 percentage points with the 14mg dose
• The 25mg and 50mg doses were also associated with statistically significantly greater weight loss (-7.0kg and -9.2kg, respectively, vs -4.5kg with the 14mg dose).
• All dosage strengths of oral semaglutide were reported to be safe and well tolerated. Mild to moderate gastrointestinal adverse reactions were most commonly observed during the study.

The higher efficacy from 25mg and 50mg doses provides the option to progress to higher doses if additional glycemic control or weight loss are needed. Regulatory approvals are expected to be filed in the US and the EU in 2023. The global roll-out of the 25 mg and 50 mg doses is dependent on portfolio prioritisations and manufacturing capacity.

Source: MPR | Read full story