Semaglutide 2 mg Approved for Additional Glycemic Control in T2D
The FDA approved a 2-mg dose of semaglutide (Ozempic) for additional glycemic control in people with type 2 diabetes. Semaglutide is indicated along with diet and exercise to improve glycemic control in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
In a phase 3 clinical trial of semaglutide injection, up to 73% of people with type 2 diabetes treated with the 1-mg dose of the medication lowered their blood sugar and reached the American Diabetes Association target of <7%. The 2-mg dose of semaglutide injection helps those who have not reached their blood sugar target with the 1-mg dose and who need additional glycemic control and is an important option for patients and providers in the ongoing treatment of type 2 diabetes, according to Novo Nordisk, the maker of semaglutide injection.
The 2-mg dose of semaglutide injection was shown in the SUSTAIN FORTE trial to be associated with a 2.1% blood glucose reduction at week 40 in people with an average starting A1C of 8.9%, compared with 1.9% with semaglutide injection 1 mg (P<.01). The same study showed the 2-mg dose of semaglutide injection was also associated with weight loss: people with an average starting weight of 219 lb treated with semaglutide injection 2 mg experienced a weight loss of 14.1 lb, compared with a weight loss of 12.5 lb with semaglutide injection 1 mg. The difference was not statistically significant.
The most common adverse events were gastrointestinal. Gastrointestinal adverse reactions occurred more frequently among patients receiving the 2-mg dose of semaglutide injection (34.0%) than the 1-mg dose (30.8%). For both doses of semaglutide injection, no new safety signals were identified.
Semaglutide injection will be available in three therapeutic doses (0.5 mg, 1 mg, and 2 mg) to help people with type 2 diabetes reach their blood sugar (A1C) goal, now including those with a higher A1C who have been unable to meet their A1C target.
Healthcare providers can access full prescribing information about semaglutide injection at the manufacturer’s website.