Novo's semaglutide hits the mark in Phase 3 type 2 diabetes study

Novo Nordisk has revealed new Phase 3a data on its glucagon-like peptide-1 (GLP-1) analogue oral semaglutide in the treatment of adult patients with type 2 diabetes and moderate renal impairment, demonstrating that the drug reduced blood sugar (HbA1c) levels and assisted weight loss to a greater degree than placebo over 26 weeks of treatment, meeting its primary endpoint.

The drug was stacked up against placebo in a trial of 324 participants with type 2 diabetes and moderate renal impairment inadequately controlled with metformin, sulfonylurea alone or in combination with metformin, or basal insulin alone or in combination with metformin.

Applying a secondary statistical approach, it was shown that patients treated with semaglutide reported a 1.1% reduction in HbA1c, compared to just 0.1% with placebo, while reduction in body weight was demonstrated as 3.7kg compared to 1.1kg with placebo.

The trial, known as PIONEER 5, is just one of ten such studies investigating the drug that a due to wrap up this year. Semaglutide is currently delivered as a weekly patient-friendly injection, but analysts predict that Novo could add billions to the drug’s revenue if it is able to secure approval for a daily pill formulation.

"The results from PIONEER 5 showed that oral semaglutide is efficacious and has a solid safety profile in people with type 2 diabetes and moderate renal impairment, thereby further expanding the solid clinical profile of oral semaglutide," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk. "Renal impairment is a serious diabetes complication and people with this condition have limited oral anti-diabetic treatment options, and if approved oral semaglutide represents an efficacious new solution for these people."

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