Novo jumping into phase III trials for major oral diabetes candidate
- If approved, Novo Nordisk's investigational oral semaglutide will become the first non-injectable GLP-1 agonist. The company is launching larger-scale phase III trials on the heels of earlier, promising data.
- GLP-1 agonists facilitate glucose-dependent insulin release, improved weight management and effective blood glucose (BG) control. This class is also associated with an extremely low risk of hypoglycemia.
- The first phase III trial will start in Q1 2016.
The first phase III trial is designed to evaluate the efficacy and safety of once-daily oral semaglutide by comparing Novo's investigational drug at three doses (3mg, 7mg and 14mg) with once-daily Januvia (sitagliptin), a DPP-4 inhibitor from Merck.
In phase II trials, patients were treated with one of five different doses of semaglutide, ranging from 2.5 mg to 40 mg. Semaglutide-treated patients achieved statistically significant dose-dependent improvements in HBA1c (from a mean baseline HBA1c of 7.9%) of 0.7% to 1.9% after 26 weeks, compared with improvements of 0.3% in placebo-treated patients. Overall, all doses of oral semaglutide were statistically superior to placebo.
Now, researchers are swapping out placebo for Januvia, with the goal of establishing oral semaglutide as a treatment option which can be used in combination with other drugs, or as a next step after monotherapy with metformin has proven ineffective.