Novo Nordisk announced new data from the Phase 3a PIONEER 5 trial which evaluated oral semaglutide in adult patients with type 2 diabetes and moderate renal impairment.
PIONEER 5 (N=324) was a randomized, double-blind, placebo-controlled, parallel-group, 26-week trial that evaluated the safety and efficacy of oral semaglutide 14mg vs placebo in patients with type 2 diabetes and moderate renal impairment (eGFR 30 to 59mL/min/1.73m2) inadequately controlled with metformin, sulfonylurea alone or in combination with metformin, or basal insulin alone or in combination with metformin.
According to the primary statistical approach (treatment effect regardless of discontinuation of treatment or initiation of rescue medication), treatment with semaglutide was associated with statistically significantly greater reductions in HbA1c compared with placebo at week 26. In addition, patients treated with oral semaglutide achieved statistically significant and superior reductions in body weight vs placebo at week 26.
Using the secondary statistical approach (treatment effect while on treatment without use of rescue medication), results showed that semaglutide-treated patients had a statistically significantly greater HbA1c reduction vs placebo (1.1% vs 0.1%). Regarding body weight, there was a greater reduction with semaglutide vs placebo (3.7kg vs 1.1kg). Among patients who had baseline HbA1c of 8.0%, a greater proportion of semaglutide-treated patients achieved the American Diabetes Association (ADA) target of <7.0% at week 26 compared with those in the placebo arm (64% vs 21%).
The safety profile of oral semaglutide was similar to other GLP-1 based treatments with mild to moderate nausea being the most common adverse event.
“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,” stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Semaglutide is currently available as a subcutaneous injection for the treatment of type 2 diabetes in adults.
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