Higher Dose Ozempic Helps Lower A1C and Improves Weight Loss
By Matthew Garza
The FDA approved Ozempic for a 2.0 mg dose, which was based on clinical trial data showing the higher dose led to a better A1C and to weight loss.
The FDA recently approved Novo Nordisk’s 2.0 mg dose of the once-weekly injectable Ozempic (semaglutide) based on results from the SUSTAIN FORTE clinical trial. Ozempic 2.0 mg, a GLP-1 receptor agonist, previously only available at the 0.5 mg and 1.0 mg doses, is now approved for type 2 diabetes and to reduce the risk of heart attack, stroke, or cardiac death in adults with type 2 diabetes and with heart disease.
The SUSTAIN FORTE clinical trial showed better outcomes over 40 weeks for the 2.0 mg dose compared to the 1.0 mg dose. However, negative gastrointestinal side effects did occur more frequently among patients receiving the higher dose (34% compared to 30.8%).
|
|
2.0 mg dose group |
1.0 mg dose group |
|
Average A1C at the start of the Trial |
8.9% |
8.8% |
|
Average A1C at 40 weeks |
6.7% |
6.9% |
|
Average reduction in A1C |
2.2 percentage points |
1.9 percentage points |
|
Percent of group achieving an A1C of 6.5% or lower |
52% |
39% |
|
Percent of group who had at least 5% weight reduction |
59% |
51% |
|
Percent of group who had at least 10% weight reduction |
28% |
23% |
Two other drugs, Rybelsus or Wegovy, are similar to Ozempic; all three of these medications are different forms of semaglutide. Rybelsus is a daily pill for people with type 2 diabetes while Wegovy is a 2.4 mg once-weekly injection for treating obesity.
Having an additional dosing option for Ozempic will give healthcare providers and people with diabetes an additional alternative to personalize treatment based on their health goals.
In addition, not all health insurance plans cover obesity treatment, so people with diabetes and excess weight or obesity may not have been able to access Wegovy with the higher dose of semaglutide. Because Ozempic is already an established diabetes medication covered by most insurance plans and Medicare, access to a higher dose may not be a problem.
Novo Nordisk has said that it hopes to make the 2.0 mg dose of Ozempic available in the US in the next few months. This dosing option is also approved in Canada, Switzerland, and Europe.
