The type 2 diabetes drug Ozempic (generic name semaglutide) is now approved at a higher dosage level in the United States, giving prescribers three different dosage options for this weekly injectable drug, according to a press release from manufacturer Novo Nordisk.
Ozempic was first approved as a treatment for type 2 diabetes by the U.S. Food and Drug Administration (FDA) in 2017. Two different dosages were approved at that time for weekly injection — 0.5 milligrams (mg) or 1 mg, depending on a person’s needs for blood glucose control. In the original clinical trial that led to its approval, taking Ozempic was also linked to substantial weight loss — an average of 9.5 pounds in participants who took 0.5 mg, and 13.5 pounds in those who took 1 mg. Further studies showing the drug’s potential as a treatment for weight loss led to a higher dose of 2.4 mg being approved as a standalone weight-loss treatment, under the new brand name Wegovy. But until now, any dose of semaglutide higher than 1 mg has been approved only for weight loss — not as a treatment for type 2 diabetes — due to the lack of evidence showing that a higher dose may be beneficial for blood glucose control.
To get cutting-edge diabetes news, strategies for blood glucose management, nutrition tips, healthy recipes, and more delivered straight to your inbox, sign up for our free newsletters!
Higher dose of Ozempic linked to A1C reductions
But that all changed when new data was presented to the FDA, leading to the latest approval for Ozempic at a higher dose. In a clinical trial called SUSTAIN FORTE, participants with an average starting A1C level (a measure of long-term blood glucose control) of 8.9% who took 2 mg of Ozempic weekly experienced an average A1C reduction of 2.1% after 40 weeks, compared with an A1C reduction of 1.9% for those who took 1 mg of Ozempic weekly. While this doesn’t look like a huge difference in outcomes between the two dosage levels, this difference was found to be statistically significant — meaning it wasn’t due to chance or the influence of factors other than the drug treatment. And even a further A1C reduction of 0.2% may turn out to be important in the long run, when it comes to the risk of developing complications of diabetes.
Participants who took the higher dose of Ozempic also experienced slightly more weight loss after 40 weeks, although this difference was not statistically significant — an average loss of 14.1 pounds in the 2-mg group compared with 12.5 pounds in the 1-mg group, from a starting average body weight of 219 pounds. There were no new indications of safety risks linked to the higher dose of Ozempic, although participants who took this dose were slightly more likely to experience gastrointestinal adverse reactions — something that happened in 34.0% of those who took 2 mg, and in 30.8% of those who took 1 mg weekly.
“Type 2 diabetes is a complex disease that can progress over time even if a person is managing it with medication, diet, and exercise,” said study author Juan Pablo Frias, MD, medical director at Velocity Clinical Research in Los Angeles, in the press release. “We have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift.”
“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,” added Doug Langa, executive vice president of North America operations and president of Novo Nordisk Inc., in the press 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.”
Want to learn more about GLP-1 agonists (the class of medicine to which Ozempic belongs)? Read “GLP-1 Agonists: Getting to Know These Diabetes Drugs Better.”