Ozempic (Semaglutide): An FDA-Approved GLP-1 Agonist

Could this option be the next blockbuster drug for diabetes?

ozempic pen
Ozempic/Novo Nordisk

The U.S. Food and Drug Administration (FDA) approved the use of a new GLP-1 agonist, Novo Nordisk's Ozempic (semaglutide), as an adjunct to diet and exercise for the treatment of type 2 diabetes in adults. It is expected to be available within the first three months of 2018.

This is encouraging, particularly given that the American Diabetes Association recently published about the benefits of certain GLP-1 agonists in the 2018 Standards of Diabetes Care. They noted the drug's ability to reduce the risk of major adverse cardiovascular events, including heart attack, stroke, and cardiovascular death, in adults with type 2 diabetes and established cardiovascular disease.

How Does Ozempic Work?

Semaglutide is the seventh GLP-1 agonist to be approved in the United States and the fourth once-weekly injectable to receive approval (Tanzeum is soon to be discontinued). Clinical trials have shown that it will be quite effective.

In a recently reported “head-to-head” trial, Ozempic showed greater A1c reduction than Trulicity (1.8 percent versus 1.4 percent) and significantly more than Bydureon (AstraZeneca), another once weekly GLP-1 agonist. Semaglutide has also proven to yield a greater weight loss than its counterparts (approximately 10 to 14 pounds versus five to seven pounds when using Victoza).

GLP-1 agonists, like semaglutide, work to reduce blood sugar by targeting specific parts of the body, including the brain, muscle, pancreas, liver, and stomach. Perhaps part of the efficacy lies in that semaglutide has a 94 percent homology to human GLP-1. Many people with type 2 diabetes have lower levels of GLP-1, which can result in elevated blood sugar levels.

When injected, the GLP-1 agonist sends a signal to the brain to reduce intake of food and water; in doing so, people with type 2 diabetes are more likely to consume fewer calories, lose weight, and reduce their blood sugars.

While the brain is being told to stay full, GLP-1 agonists also work on the stomach to reduce acid secretion and decrease gastric emptying, which slows down how quickly food leaves your stomach, increasing fullness and reducing how fast blood sugars rise, which often causes nausea.

Additionally, GLP-1 agonists help to reduce after-meal blood sugars by stimulating the pancreas to make insulin when it comes in contact with food and lowering hepatic (liver) glucose output (a process medically known as gluconeogenesis).

Side Effects

Like all medications, there is a risk for potential side effects. The most common side effect reported was mild to moderate nausea, which was typically observed to diminish over time. Other common adverse reactions, reported in at least five percent of patients treated with Ozempic, were vomiting, diarrhea, abdominal pain, and constipation.

There are solutions to these side effects that you can discuss with your doctor to make sure that the medication isn't disrupting your day-to-day. Remember, it's meant to help you, not cause additional issues.

Contraindications

Ozempic has many benefits, but it isn't for everyone. It should not be used by people with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. This is because in mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas). Therefore, it is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

Additionally, people who have a history of diabetic retinopathy (eye disease) are discouraged from using this medication as it can worsen symptoms and cause complications. It was reported that the risk of diabetic retinopathy and it's complications is higher in those using Ozempic who also have established diabetic retinopathy versus those who do not. The slightly higher retinopathy risk may be linked to very rapid reductions in A1c when starting the medication. Many insulins feature a similar warning.

Lastly, for those people who have a history of pancreatitis, this medication is not recommended. Studies have shown that those people taking Ozempic have reported acute and chronic pancreatitis. It is suggested that people who decide to take this medication are observed carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back with or without vomiting. If pancreatitis is suspected the medication should be stopped and if it is diagnosed, it should not be restarted.

If you fall into one of these groups, don't feel discouraged about finding treatment. There are other options your doctor can recommend that fits you better.

Administration and Dosing

Ozempic comes in a prefilled, disposable FlexTouch pen and is injected subcutaneously into fatty tissue once per week. The starting dose is 0.25 mg for initiation and after four weeks the dose is increased to 0.5 mg once weekly. If after at least four weeks additional blood glucose control is needed, your physician may increase the dose to 1 mg once weekly.

You can take this medication at any time of day, with or without food. Your physician or certified diabetes educator will educate you on proper injection technique and dosing.

Cost and Health Insurance Coverage

Most of the time, newer medications tend to be a bit more pricey as compared to those that have been around for a long time. However, Novo Nordisk has indicated that Ozempic will be priced “on par” with other once-weekly GLP-1 agonists. It is anticipated that those with insurance coverage should pay a similar amount to other drugs in this class.

Oftentimes, copay savings cards are available for those without insurance coverage. If you have specific questions about payment you can speak to a Novo Nordisk customer representative.

Future Developments

GLP-1 receptor agonists have proven to be an extremely beneficial adjunct to diet and exercise for those people with type 2 diabetes. And while they are still not indicated as a first line drug treatment, they are being used more often as a second line agent. Because they increase the likelihood of weight loss and can potentially have benefits for heart health, they will most likely be a preferred add-on agent to Metformin.

Interestingly, Novo Nordisk is also working towards two more possible developments for this drug. They are conducting studies to assess whether Ozempic has benefits for heart health as well as the use of Ozempic specifically as a weight-loss therapy for obesity.

Additionally, a pill version of Ozempic is also in clinical trials; this could very likely be the first GLP-1 agonist not to require any injections at all. That could be a total game changer for people with diabetes—to be able to have the same benefits without injection would be extremely appealing.

A Word From Verywell

So far, research suggests that Ozempic may yield greater blood sugar control and more weight loss.

Of course, there are some drawbacks—injecting the medication, common side effects, increased risk of retinopathy, and potential cost, to name a few. But, you should weigh the pros and cons with your health care provider and determine if the potential weight loss, improved blood sugar control, and potential heart health benefits outweigh these risks.

Stay tuned for more information on its effect on heart health as well as new developments brewing, such as the approval of a pill form.

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