Novo Nordisk says trial data show an oral formulation of its GLP-1 analogue semaglutide provided superior HbA1c and weight reductions versus placebo in people with type II diabetes and renal impairment.
The PIONEER 5 study looked at the efficacy and safety of 14mg oral semaglutide versus placebo in 324 people with type II 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.
Two distinct statistical approaches to assessing the effects of the drug were applied in trial; a primary statistical approach required by recent regulatory guidance evaluating the effect regardless of discontinuation of treatment and use of rescue medication, and a secondary statistical approach, describing the effect while on treatment and without use of rescue medication.
The study met its key objective according to the primary statistical approach, showing significant and superior reductions in HbA1c with oral semaglutide compared to placebo at week 26. Furthermore, people treated with oral semaglutide achieved significant and superior reductions in body weight compared to placebo.
When applying the secondary statistical approach, people given oral semaglutide experienced a significantly greater reduction in HbA1c of 1.1 percent compared to 0.1 percent with placebo. Reduction in body weight was also significantly greater with a reduction of 3.7 kg compared to 1.1 kg with placebo.
During the trial, oral semaglutide was well-tolerated in people with moderate renal impairment, with a profile consistent with GLP-1-based therapies, Novo said.
Some 19 percent in the treatment arm experienced nausea, compared to 8 percent of people given a placebo, while the proportion of people who discontinued treatment due to adverse events was 15 percent versus 6 percent, respectively.
“The results from PIONEER 5 showed that oral semaglutide is efficacious and has a solid safety profile in people with type II diabetes and moderate renal impairment, thereby further expanding the solid clinical profile of oral semaglutide,” said Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer.
“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.”
Back in June, the firm released data from the PIONEER 3 trial showing oral semaglutide was better at reducing blood sugar than MSD’s DPP-4 inhibitor Januvia (sitagliptin) in patients with type II diabetes, which followed results of PIONEER 2 showing an greater improvement in HbA1c reduction than Boehringer Ingelheim's Jardiance (empagliflozin).