FDA approves 2 mg semaglutide to lower HbA1c in type 2 diabetes
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The FDA has approved a once-weekly 2 mg semaglutide injection in conjunction with diet and exercise to lower HbA1c and reduce the risk for cardiovascular events for adults with type 2 diabetes, according to a press release.
As Healio previously reported, the FDA previously approved 0.5 mg and 1 mg once-weekly semaglutide injections (Ozempic, Novo Nordisk) to improve glycemic control in adults with type 2 diabetes in 2017. The latest approval now allows for 2 mg of semaglutide to be prescribed for adults whose target HbA1c is not met with lower doses. Novo Nordisk plans to launch 2 mg semaglutide in the U.S. in the near future, according to the company press release.
"Type 2 diabetes is a complex disease that can progress over time even if a person is managing it with medication, diet and exercise," Juan Pablo Frias, MD, FACE, medical director of Velocity Clinical Research in Los Angeles and principal investigator of the SUSTAIN FORTE clinical trial, said in the release. "With its proven safety and efficacy, Ozempic helps deliver on blood glucose control and offers major CV event risk reduction in adults with type 2 diabetes and known heart disease, plus it can help many patients lose some weight. With a 2 mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift."
In findings from the SUSTAIN FORTE phase 3 trial, adults with a mean HbA1c of 8.9% at baseline had a 2.1% reduction in HbA1c at 40 weeks with 2 mg semaglutide compared with a 1.9% reduction for those assigned 1 mg semaglutide. Adults assigned 2 mg semaglutide also had a mean weight loss of 14.1 lb at 40 weeks compared with a mean weight loss of 12.5 lb with 1 mg semaglutide. The weight loss was not significantly different between the two groups.
The most common adverse events for both 2 mg and 1 mg semaglutide were gastrointestinal, occurring in 34% of participants taking 2 mg and 30.8% of those taking 1 mg.
"Ozempic is at the helm of helping Novo Nordisk drive change in diabetes care, with more than one million people with type 2 diabetes in the United States treated with Ozempic," Doug Langa, executive vice president of North America operations and president of Novo Nordisk Inc., said in the release. "With Ozempic now available in a variety of dosing strengths, we are optimistic we can help even more people living with type 2 diabetes who require more blood sugar control experience the benefits of Ozempic."
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