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News from The Endocrine Society on Oral Semaglutide

If you talk to researchers and clinicians deeply involved in the future of obesity treatment, you will find quite a buzz about a type 2 diabetes drug called semaglutide. It’s a cousin of the most successful new drug for treating obesity – liraglutide. Right now, both of these drugs are sold only as an injection. But oral semaglutide is receiving an expedited review at FDA for diabetes. Now, at the annual meeting of the Endocrine Society, it’s making news.

Better Diabetes Control and Weight Outcomes

Investigators published results of the PIONEER 3 study in New Orleans on Saturday and simultaneously published the full results in JAMA. This study compared three doses of oral semaglutide to sitagliptin in patients with type 2 diabetes. These were patients for whom metformin was not enough to control their diabetes. Some, but not all of them, were also receiving sulfonylureas.

The lowest dose of semaglutide (3 mg daily) was no more effective than sitagliptin. In fact, it might even be less effective.

But at the higher doses (7 and 14 mg daily), oral semaglutide gave better control of blood sugar and better weight outcomes compared to sitagliptin. After a year, 36% of patients on the 14 mg dose of semaglutide lost at least three percent of their initial body weight and achieved significant reductions in A1C.

On a Fast Track for Diabetes

Oral semaglutide is on a fast track for review at FDA. Last week, Novo Nordisk announced their submission with a priority review voucher that should result in a review time of only six months at FDA.

Semaglutide is presently available as a weekly injection under the brand name of Ozempic. On separate tracks, Novo Nordisk has also requested labeling for both the oral and injectable forms to say that it can prevent heart attacks, strokes, and death in patients with both diabetes and heart disease.

Obesity Indication a Few Years Away

In diabetes treatment, any weight loss with semaglutide is a bonus. That’s because a obesity treatment requires a higher dose than diabetes. The pivotal studies of semaglutide are underway for obesity and will be complete in 2020. Early stage study results were quite encouraging. But for the definitive data, we’ll have to wait and see.

Click here for the full study results in JAMA and here for reporting from the Endocrine Society meeting.

New Orleans Window, photograph © rulenumberone2 / flickr

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March 26, 2019