The FDA’s approval of Ozempic came after an in-depth analysis of eight large-scale clinical trials. These studies enrolled over 8,000 adults managing type II diabetes. A key part of this research was a two-year cardiovascular outcomes trial, which assessed the safety of Ozempic for adults with type II diabetes who are at high risk for cardiovascular complications. This focus on heart health was essential, given the increased cardiovascular risks often seen in people with diabetes.
In these trials, Ozempic consistently demonstrated significant and clinically meaningful reductions in A1c levels—a primary measure for managing blood glucose. Ozempic outperformed several comparison treatments, including a placebo, sitagliptin, and extended-release exenatide. These reductions in A1c mean that Ozempic could help many patients reach healthier blood sugar targets more effectively.
As a secondary benefit, many participants taking Ozempic also experienced reductions in body weight. This is a valuable outcome for people with type II diabetes, where weight management often plays a critical role in overall health. The weight loss, combined with the improved blood glucose control, positions Ozempic as a highly beneficial treatment option for people looking to manage type II diabetes and reduce associated health risks.
FDA CENTER WATCH, December 2017
General Information
Ozempic (semaglutide) is a glucagon-like peptide 1 (GLP-1) receptor agonist.
Ozempic is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Ozempic is supplied as a solution for subcutaneous injection into the abdomen, thigh or upper arm. The recommended starting dose is 0.25 mg once weekly. After 4 weeks, the dose should be increased to 0.5 mg once weekly. If after at least 4 weeks additional glycemic control is needed, increase the dose to 1 mg once weekly. Ozempic should be administered once weekly at any time of day, with or without meals. If a dose is missed administer within 5 days of missed dose.
Clinical Results
The FDA approval of Ozempic was based on the results from a global Phase IIIa clinical trial comprised eight clinical trials involving more than 8,000 adults with type II diabetes, including a two-year cardiovascular outcomes trial that evaluated safety in adults with type II diabetes at high risk of cardiovascular events.
Ozempic showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release. As a secondary endpoint in the trials, treatment with Ozempic resulted in reductions in body weight.
Side Effects
Adverse effects associated with the use of Ozempic may include, but are not, limited to, the following:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Constipation