FDA Approves Ozempic for Type 2 Diabetes

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The U.S. Food and Drug Administration (FDA) has approved a new medication that promises not only to control blood sugar in people with diabetes but also to help them lose weight.

The drug, called Ozempic (semaglutide), is manufactured by Novo Nordisk and is designed to promote the production of insulin in the body while simultaneously suppressing appetite. The FDA approval is based on a global trial program comprised of eight clinical trials involving more than 8,000 adults with Type 2 diabetes. The program also evaluated participants for cardiovascular safety and found no risk.

According to the manufacturer, the results of the trials showed “clinically meaningful and statistically significant reductions” in blood glucose as measured by A1C tests (a test that provides information about a person’s average levels of blood glucose over the preceding three months). In addition, treatment with Ozempic resulted in reductions in body weight.

Ozempic comes in two dose sizes — 0.5 mg (milligrams) and 1 mg. In one of the trials, participants who received a lower dose lost an average of 9.5 pounds while those who received the higher dose lost an average of 13.5 pounds.

Ozempic is injected once a week on the same day each week and to be combined with diet and exercise. It can be used at any time of day with or without meals. Users administer the injection themselves by means of a pre-filled pen. The manufacturer recommends that it be injected under the skin of either the stomach, the thigh, or the upper arm, and the injection site be rotated with each weekly dose. The cost is about the same as other once-daily injection medications.

According to Helena Rodbard, MD, a former president of the American Association of Clinical Endocrinologists, “The approval of semaglutide offers healthcare professionals an important new treatment option to help adults with Type 2 diabetes meet their A1C goals.” Next up is a trial of the drug on patients under 18.

Want to learn more about diabetes drugs? Read the “Diabetes Medicines” series from certified diabetes educator Amy Campbell, covering metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors, SGLT2 inhibitors, alpha-glucosidase inhibitors, bile acid sequestrants and dopamine receptor agonists, and non-insulin injectable diabetes medications.

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