Novo Nordisk Initiates First Phase III Trial of Once-Weekly Insulin Icodec Combined with Semaglutide for Type 2 Diabetes

On April 14, the clinicaltrials.gov website showed that Novo Nordisk had initiated a Phase III clinical trial to evaluate the effectiveness of Icodec + Semaglutide in lowering blood glucose levels in patients with type 2 diabetes. The primary endpoint of the study is the change in glycated hemoglobin (HbA1c) levels at week 52 compared to baseline. Click to read the original text for more details about the study.

This study is a single-arm clinical trial conducted in the Czech Republic and Thailand, planning to enroll 148 patients, with an expected start in September 2023 and completion in March 2025. During the initial 26-week run-in period, enrolled patients will receive once-weekly Icodec treatment to determine the optimal dose. Thereafter, patients meeting the intensification criteria will receive once-weekly semaglutide treatment (titrated from 0.25mg to 1mg) for 26 weeks along with continued Icodec treatment.

Icodec is a once-weekly insulin formulation developed by Novo Nordisk, with a half-life of up to 196 hours. Currently, Icodec has completed several head-to-head Phase III clinical trials targeting patients with type 2 diabetes and type 1 diabetes. Novo Nordisk plans to submit the marketing application for Icodec in the United States, Europe, and China in the first half of this year.

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