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July 2019

First oral GLP1-RA as effective as injectable therapy



The first oral glucagon-like peptide1 receptor agonist (GLP1-RA) has proved to be as effective as an injectable version of the drug class in terms of controlling blood glucose, and more effective than the SGLT2 inhibitor, empagliflozin.

Data from the PIONEER series of studies were presented at the American Diabetes Association (ADA) Scientific Sessions in San Francisco last month.

In PIONEER 4, oral semaglutide was as effective as (injectable) liraglutide, and demonstrated statistically significant reductions in A1c and superior reductions in body weight (4.3kg for orasemaglutide, 3.1kg for liraglutide).

The PIONEER 2 study showed that oral semaglutide, compared with empagliflozin, resulted in a superior A1C reduction at 26 weeks (1.3% versus 0.9%) and a statistically significant reduction at 52 weeks. The reduction in body weight with oral semaglutide was similar to empagliflozin (3.8kg versus 3.6kg with empagliflozin at 52 weeks).

In addition, the cardiovascular outcomes trial (CVOT), PIONEER 6, confirmed the cardiovascular safety of oral semaglutide in people with type 2 diabetes and established, or at high risk of, cardiovascular disease.

Professor Ildiko Lingvay, PIONEER investigator of University of Texas Southwestern Medical Center, Dallas, Texas said: ‘Despite their proven safety and efficacy, GLP-1 receptor agonists are underutilised. I’m encouraged by these findings and the potential of oral semaglutide to be the first oral GLP-1 receptor agonist.’

Semaglutide is available in the UK in an injectable version (Ozempic®). The manufacturer, Novo Nordisk, has submitted an application for fast track review of oral Ozempic by the Federal Drug Administration (FDA) in the US.

It is predicted that once-daily oral GLP1-RAs will be preferred by patients to injectable therapies – even those that only require once-weekly dosing – and could improve adherence.

ADA Scientific Sessions, San Francisco CA, June 2019