Global health care company Novo Nordisk A/S (CPH:NOVOB) reported on Thursday headline results from PIONEER 10, a phase 3a trial with oral semaglutide vs once-weekly subcutaneous dulaglutide, both in combination with one oral antidiabetic drug in Japanese adults with type 2 diabetes.

Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. This trial investigated the safety, tolerability and efficacy of 3, 7 and 14 mg oral semaglutide, as compared with 0.75 mg once-weekly dulaglutide in 458 Japanese people with type 2 diabetes. Prior to enrolment, participants were inadequately controlled on one oral antidiabetic drug.

According to the company, this trial achieved its primary objective by demonstrating a comparable number of adverse events with oral semaglutide compared to 0.75 mg dulaglutide. The proportion of people treated with 3, 7 and 14 mg oral semaglutide who experienced gastro-intestinal adverse events were 31%, 39% and 54%, respectively, compared to 40% with dulaglutide; the most frequently reported events being constipation and nausea.

The proportion of people who discontinued treatment due to adverse events was between 3% and 6% of people treated with oral semaglutide, as compared to 3% of people treated with dulaglutide.

PIONEER 10 was a 57-week, randomised, open-label, active-controlled, parallel-group, multi-centre, single country trial with four treatment arms, comparing the safety, tolerability and efficacy of 3, 7 and 14 mg oral semaglutide with 0.75 mg dulaglutide (the approved dose by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan) in Japanese people with type 2 diabetes inadequately controlled with one oral antidiabetic drug (sulfonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or sodium glucose cotransporter-2 inhibitor).

PIONEER 10 randomised 458 people in a 2:2:2:1 manner to receive either a dose of oral semaglutide 3, 7 or 14 mg once daily or 0.75 mg dulaglutide once weekly. The primary endpoint was the number of adverse events during exposure to the drug, assessed up to 57 weeks. Key secondary endpoints included the change from baseline to week 26 and 52 in HbA1c and change from baseline to week 26 and 52 in body weight.

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.