Novo Nordisk Launches Phase III Trial of Oral Semaglutide Versus Empagliflozin and Metformin in Treatment-Naïve Type 2 Diabetes Patients

On October 16, Novo Nordisk registered a Phase III study on the clinicaltrials.gov website to evaluate the efficacy and safety of oral semaglutide versus empagliflozin or metformin in treating newly diagnosed Type 2 diabetes patients.

The study plans to recruit 912 subjects, who will be randomly assigned to receive treatment with either oral semaglutide (25mg or 50mg, once daily), empagliflozin tablets (25mg), or metformin tablets (2000mg). The study will last for 2 years and 7 weeks (111 weeks). The primary endpoint is the change in glycated hemoglobin (HbA1c) levels at week 52, while secondary endpoints will also assess changes in body weight.

In September 2019, semaglutide tablets (Rybelsus, specifications: 3/7/14mg) were approved by the FDA for marketing to assist dietary and exercise measures in treating type 2 diabetes, becoming the first and only orally available GLP-1 analog.

Since 2016, Novo Nordisk has conducted four Phase III clinical trials to explore the first-line treatment potential of Rybelsus, with the remaining three being:

• PIONEER1 (N=703): Rybelsus monotherapy (3/7/14mg) compared with placebo in treating type 2 diabetes patients controlling blood sugar only through exercise and diet.
  

• PIONEER9 (N=243): Rybelsus monotherapy (3/7/14mg) compared with placebo and liraglutide in treating type 2 diabetes patients controlling blood glucose only through exercise and diet.

• PIONEER11 (N=521): Rybelsus monotherapy (3/7/14mg) compared with placebo in treating type 2 diabetes patients controlling blood sugar only through exercise and diet.

Based on the results of the aforementioned studies, semaglutide tablets (Rybelsus, specifications: 3/7/14mg) received FDA approval for a new indication in January 2023, for the treatment of adult patients with type 2 diabetes who have not previously received diabetes medication.This approval also means that semaglutide can be used as a first-line treatment option for patients with type 2 diabetes.。

According to the 2022 ADA/KDIGO (American Diabetes Association/Kidney Disease: Improving Global Outcomes) consensus report, the first-line treatment for patients with type 2 diabetes isSGLT2 Inhibitors（eGFR≥20）、Metformin(eGFR≥30), maximum tolerated dose of RAS inhibitors (with hypertension) or medium to high dose statins, primarily the first two.

Source: ADA/KDIGO Consensus Report

If the study NCT06083675 yields positive results, Rybelsus is expected to further capture market share from SGLT2 inhibitors and metformin.

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