Oral Semaglutide Demonstrates Efficacy in Lowering Blood Glucose and Body Weight in Phase 3a Trials for Type 2 Diabetes

Recently, Novo Nordisk presented the latest data from two Phase 3a clinical trials of oral semaglutide at the American Diabetes Association (ADA) Annual Scientific Sessions. Compared with the control drug, it not only lowered blood glucose levels but also helped reduce body weight in patients with type 2 diabetes.

As an analog of native human glucagon-like peptide-1 (GLP-1), semaglutide stimulates insulin secretion and suppresses glucagon release in a glucose-dependent manner, while also reducing appetite and food intake. It has demonstrated considerable efficacy in a series of clinical trials.

The data presented herein are derived from the PIONEER 2 and PIONEER 4 clinical trials. In the first trial, oral semaglutide (14 mg) demonstrated a greater reduction in glycated hemoglobin (A1C) levels at 26 weeks compared with the control drug empagliflozin (25 mg), with reductions of 1.3% and 0.9%, respectively (p<0.0001). This outcome met the primary clinical endpoint. Regarding the secondary clinical endpoint, patients receiving oral semaglutide also exhibited a significant reduction in A1C levels at 52 weeks. There was no significant difference between the two groups in terms of weight loss.

In the PIONEER 4 clinical trial, oral semaglutide (14 mg) demonstrated non-inferiority to Victoza in reducing A1C levels at week 26. Compared with placebo, it achieved a significant reduction in A1C levels. Regarding secondary endpoints, oral semaglutide showed superior A1C reduction compared to both Victoza and placebo at week 52. In terms of weight loss, oral semaglutide was superior to both Victoza and placebo at weeks 26 and 52, with the difference reaching statistical significance at week 52. Specifically, oral semaglutide resulted in a weight loss of 4.3 kg, compared to 3.0 kg in the Victoza group and 1.0 kg in the placebo group.

▲The injectable formulation of semaglutide was approved in 2017 (Image source: Novo Nordisk)

“Although its safety and efficacy have been validated, GLP-1 receptor agonists are not yet fully utilized in clinical practice,” said Dr. Ildiko Lingvay, lead investigator of the two studies. “As a physician, I am encouraged by these results. Oral semaglutide has the potential to become the first oral GLP-1 receptor agonist for patients with type 2 diabetes.”

References:

[1] Oral semaglutide showed superior reductions in blood sugar vs Jardiance® and non-inferior blood sugar reductions vs Victoza® in adults with type 2 diabetes at 26 weeks, Retrieved June 8, 2019, from https://www.prnewswire.com/news-releases/oral-semaglutide-showed-superior-reductions-in-blood-sugar-vs-jardiance-and-non-inferior-blood-sugar-reductions-vs-victoza-in-adults-with-type-2-diabetes-at-26-weeks-300864177.html

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