Global healthcare company Novo Nordisk A/S (CPH:NOVOB) reported on Monday the headline results from PIONEER 5, a phase 3a trial with oral semaglutide in adults with type 2 diabetes and moderate renal impairment.

Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. This 26-week trial investigated the efficacy and safety of 14 mg oral semaglutide compared with placebo in 324 people 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.

Reportedly, two distinct statistical approaches to evaluating the effects of oral semaglutide were applied in the PIONEER 5 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.

According to the company, this trial achieved its primary objective according to the primary statistical approach by demonstrating statistically significant and superior reductions in HbA1c with oral semaglutide, as compared to placebo at week 26. In addition, people treated with oral semaglutide achieved statistically significant and superior reductions in body weight compared to placebo at week 26.

When applying the secondary statistical approach, people treated with oral semaglutide experienced a statistically significantly greater reduction in HbA1c of 1.1% compared to 0.1% with placebo. Reduction in body weight was statistically significantly greater with oral semaglutide at week 26, with a reduction of 3.7 kg (kilograms), as compared to 1.1 kg with placebo. From a baseline HbA1c of 8.0%, the proportion of people achieving the American Diabetes Association (ADA) target of HbA1c below 7.0% was statistically significantly greater with 14 mg oral semaglutide, with 64% achieving the target at week 26, compared to 21% with placebo.

In conclusion, 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.

PIONEER 5 was a 26-week, randomised, double-blind, placebo-controlled, parallel-group, multicentre, multinational trial with two arms comparing the efficacy and safety of 14 mg oral semaglutide with placebo in people 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. PIONEER 5 randomised 324 people in a 1:1 manner to receive either a dose of 14 mg oral semaglutide or placebo once daily. The primary endpoint was change from baseline to week 26 in HbA1c. Key secondary endpoints included change in body weight, change in fasting plasma glucose from baseline to week 26 and proportion of people achieving HbA1c below 7.0% at 26 weeks.

The PIONEER phase 3a clinical development programme for oral semaglutide is a global development programme with enrolment of 8,845 people with type 2 diabetes across 10 clinical trials, which are all expected to complete in 2018.