From the Journals

Oral semaglutide achieves outcomes similar to those of subcutaneous semaglutide

 

Key clinical point: Oral semaglutide achieves similar glucose control in patients with type 2 diabetes when compared with subcutaneous semaglutide.

Major finding: The estimated treatment difference in HbA1c compared with placebo ranged from –0.4% to –1.6% in the oral semaglutide group, and –1.6% for the subcutaneous group

Data source: A phase 2, randomized, parallel-group, dosage-finding trial of 632 patients with type 2 diabetes.

Disclosures: Semaglutide manufacturer Novo Nordisk provided editorial support. Three authors declared board membership and consultancy fees from the company, as well as institutional grants, lecture fees and other funding from other pharmaceutical companies. Two authors declared shares in Novo Nordisk. One author declared a patent relating to semaglutide, and two authors declared funding from pharmaceutical companies including Novo Nordisk.


 

FROM JAMA

 

Oral semaglutide can achieve levels of glycemic control and weight loss similar to those of subcutaneous semaglutide, according to a phase 2, placebo-controlled trial published in the Oct. 17 edition of JAMA.

Dr. Melanie Davies, professor of diabetes medicine at the University of Leicester, England
Dr. Melanie Davies
The study set a treatment target of an HbA1c level of less than 7%. This was achieved by 44% of patients in the 2.5-mg group, 81% of those in the 5-mg group, 84% of those in the 10-mg group, 86% of those in the 20-mg group, and 90% of those in the 40-mg standard escalation groups. It was achieved by 93% of those in the subcutaneous group and 28% of those in the placebo group.

Researchers also saw a dose-dependent decrease in mean body weight from baseline to 26 weeks, ranging from –0.9 kg in the 2.5-mg group to –5.7 kg in the 40-mg standard escalation group, compared with –1.2 kg in the placebo group. The difference between treatment and placebo was significant only for doses at or above 10 mg.

The most common adverse events reported were mild to moderate gastrointestinal problems, mostly associated with oral and subcutaneous semaglutide, which are a known side effect of GLP-1 receptor agonists. There was also a higher rate of premature discontinuation of treatment due to gastrointestinal effects in the semaglutide-treated patients.

However, the overall rate of hypoglycemic episodes was low, and was similar in both semaglutide groups and the placebo group.

There were three cases of acute pancreatitis in patients treated with semaglutide, and the treatment was also associated with a significant increase in heart rate, compared with placebo.

“A longer study duration may have demonstrated the maximum HbA1c level and weight reductions in the groups administered the higher doses of the medication,” wrote Melanie Davies, MD, professor of diabetes medicine at the University of Leicester, England, and her coauthors. “Future trials should assess the efficacy of oral semaglutide in patients with a high baseline HbA1c level to explore its potential in patients who are less well controlled, and in combination with other glucose-lowering agents.”

Semaglutide manufacturer Novo Nordisk provided editorial support. Three authors declared board membership and consultancy fees from the company, as well as institutional grants, lecture fees, and other funding from other pharmaceutical companies. Two authors declared shares in Novo Nordisk. One author declared a patent relating to semaglutide, and two authors declared funding from pharmaceutical companies including Novo Nordisk.

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