According to a recent study, the diabetes medication semaglutide is more effective as a 25 mg or 50 mg dose on its own, rather than a 14 mg add-on dose with other medications.
An increased dose of the diabetes treatment semaglutide caused significant improvement in blood sugar levels and body weight for patients with type 2 diabetes (T2D), according to study results.1
The phase 3 trial PIONEER PLUS was conducted over the span of 68 weeks and included more than 10,000 patients with T2D. “The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c [hemoglobin A1C] at week 52 with both the 25 mg and 50 mg doses versus the 14 mg dose of oral semaglutide,” Novo Nordisk said in the statement.
“We are pleased to see the results from the PIONEER PLUS trial” and the results provide “further evidence of the benefits of oral semaglutide” for patients with T2D, said Martin Holst Lange, executive vice president for Development at Novo Nordisk.
Blood sugar levels—perhaps the most important number to track for patients with diabetes—were reduced more significantly with the higher dose. At baseline, the mean HbA1C was 9.0% for patients. For both doses, patients achieved statistically significant HbA1c reduction of 1.9 percentage points for the 25 mg dose and 2.2 percentage points for the 50 mg dose. In comparison, the reduction in mean HbA1C from baseline was 1.5 percentage points for oral semaglutide 14 mg.
Not only were blood pressure levels impacted positively, but there was a statistically significant body weight loss for patients on the higher doses. At baseline, the mean body weight was 96.4 kg. People treated with oral semaglutide 25 mg lost 7.0 kg, and people treated with 50 mg lost 9.2 kg. Patients on oral semaglutide 14 mg only lost 4.5 kg.
The increased dosage of semaglutide did not pose any risks and the drug appeared to be safe and well tolerated, the release said.
Being able to ingest a higher dose of semaglutide could provide more options for patients with T2D, and the study suggests that even higher doses may be used in the future for patients who need additional assistance with glycemic levels or weight loss.
Novo Nordisk has experienced multiple controversies regarding diabetes treatments in the past, most notably in 2017 when it had to pay nearly 60 million dollars2 for failing to alert doctors of potential risk of cancer in its diabetes drugs, namely Victoza. However, in March 2022, Nordisk won an appeal claim3 over the drug, and said it "firmly stands behind the safety of Victoza."
The company says it plans to make the 25 mg and 50 mg doses of semaglutide available by the end of 2023, but that hinges on “manufacturing capacity.” Currently, doses up to 14 mg are available for use.