Ozempic: Sugar Coated Success or the Best of Its Kind?

By Candis Morello and Parisa Karimian

In December 2017, Ozempic (semaglutide) received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with type 2 diabetes (T2D).

Combined with eating healthy meals and regular activity, Ozempic may be used alone or with other diabetes medications. Ozempic is the 4th once-weekly glucagon like peptide-1 receptor agonist (GLP-1 RA) medication to enter the market after Bydureon (exenatide extended release), Trulicity (dulaglutide), and Tanzeum (albiglutide). Ozempic is expected to be launched in the U.S. by the spring, shortly before Tanzeum’s discontinuation from the market due to issues with sales. Ozempic sets itself apart from other once-weekly GLP-1 RAs by demonstrating the quickest and greatest effect in reducing blood glucose and body weight in studies. In addition, a pill version of Ozempic is now under evaluation in clinical trials.

How Does Ozempic Work?

Similar to the other once-weekly products, Ozempic is a GLP-1 RA. Even though it is synthetic, it acts similarly to the hormone GLP-1 naturally produced by the body that is deficient in people with T2D. It promotes the pancreas to release insulin (only when glucose values are elevated), makes people feel fuller faster so they tend to eat less, and reduces the amount of glucose made by the liver. Overall glucose concentrations are better controlled throughout the day and after meals, and most people lose some weight.

How is Ozempic Used?

Ozempic comes in easy-to-use prefilled disposable injector pens of either 0.5mg or 1 mg strengths. Since Ozempic has a long half-life (about seven days), it only needs to be given once per week. Select one day of the week (like Sunday, as an example) and make that your Ozempic day. To help you remember, you can mark your calendar or set a reminder alarm in your phone.

If you miss your day and remember within five days, administer it as soon as possible and set that day of the week as your NEW Ozempic day. If it is less than two days away from your next dose, wait the two days to administer.

Choose an administration site on your stomach (at least two inches away from your belly button), thigh, or upper arm. After uncapping the pen place the pen tip against your skin. Now, you are ready to press the injection button. Keep the button pressed down for 5-10 seconds to ensure complete dose delivery. Each week use a different injection site or rotate within that side. Each pen only contains four doses. Once empty, dispose the pen in a sharps container. New pens should be stored in a refrigerator, away from light in the original box.

 What Can You Expect?

Ozempic improves both fasting and post-prandial (after meal) blood glucose concentrations; however, based on its long-acting formulation, it has a stronger effect on fasting plasma glucose. You can expect your A1c to reduce by about 1.2- 1.8%, depending on the weekly dosage used. Ozempic, like other GLP-1 RAs, is associated with low risk of low blood glucose (hypoglycemia). One benefit of Ozempic is weight loss up to 13 lbs, which is considerably greater than reports from other GLP-1 RAs on the market.

Additionally, data from the clinical studies suggest that Ozempic reduces risk of cardiovascular problems including stroke and heart attack. Longer-term trials will confirm these benefits.

Like other GLP-1 RAs, a common side-effect of Ozempic is the slowing down of stomach emptying. In addition, mild to moderate stomach upset and nausea may occur. These symptoms usually go away within a few weeks from starting Ozempic. To reduce the indigestion symptoms, eat smaller food portions throughout the day.

Is Ozempic Right for You?

Before starting Ozempic, you and your provider will want to discuss your medical and family history. Specifically discuss if you have problems with your pancreas or kidneys, have a history of diabetic retinopathy, are pregnant or planning to become pregnant, have any history of severe gastrointestinal (GI) disease, thyroid cancer, or family history of thyroid cancer. Getting an annual dilated eye exam is also recommended. Also, be sure to inform your provider of all prescriptions, over-the-counter, and herbal medications that you are taking, to avoid any interactions.

The Bottom Line:

Compared with other GLP-1 RAs, Ozempic is a strong A1c reducer with the added benefits of moderate weight loss and possible cardiovascular protection. The results of future studies will provide clinicians with more insightful information of which once-weekly GLP-1 RA is best for each individual patient. Consult with your provider to see if adding Ozempic is the next beneficial step to reach your personal glucose goals.


About the Authors:

 Parisa Karimian, 4th Year Student Pharmacist at UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.

Candis M. Morello, Pharm D, CDE, FCSHP, FASHP, Associate Dean for Student Affairs at UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, Clinical Pharmacist Specialist at VASDHS.

Two New Combo Drugs Help Blood Sugar Control for Type 2s

by Juan Pablo Frias, MD

Achieving glucose goals is a critical part of overall diabetes management. The better the glucose control the lower the risk of long-term complications . Taking two or more glucose-lowering medications is usually needed in people with type 2 diabetes to achieve normal or near-normal glucose control.

This often means adding a long-acting basal insulin (for example, Lantus, Toujeo or Tresiba) to oral medication(s). Basal insulin primarily lowers fasting glucose and glucose levels before meals. If basal insulin and oral medications do not adequately lower overall glucose control, a commonly accepted next step in treatment is to add an injectable GLP-1 receptor agonist (RA) such as Byetta or Bydurion, Victoza, Trulicity, Tanzeum or Adlyxin. These medications primarily lower glucose values after meals and may also have effects on fasting glucose. Important to people with type 2 diabetes, the GLP-1 RAs often lead to weight loss. Treatment with a basal insulin and a GLP-1 RA makes a lot of sense since both fasting and post-meal glucose are addressed, helping to lower blood sugar levels further.

“Both new fixed-ratio combination products provide people with type 2 diabetes and their providers with a treatment option that is convenient, easy-to-use, and works to safely improve glucose control by combining two medications with different mechanisms of action in one pen device.” –Dr. Juan Frias

Until recently, people using basal insulin and a GLP-1 RA had to do so by administering each medication separately, therefore needing two separate injections.  The FDA recently approved two products that combine basal insulin with a GLP-1 RA in one pen device. The two so-called “fixed ratio combination” products are Soliqua 100/33 and Xultophy 100/3.6. In published clinical trials, both combination medications were shown to result in better glucose control than basal insulin or a GLP-1 RA alone and with the added benefit of weight loss (rather than weight gain seen with insulin alone). Both medications did so without increasing the risk of hypoglycemia, and with fewer gastrointestinal side effects (e.g., nausea, vomiting, diarrhea) than with a GLP-1 RA alone. So, basically, these combinations offer better glucose control with lower risk of adverse effects than the individual components alone.

Soliqua 100/33 is approved for people with type 2 diabetes who are not achieving glucose goals on less than 60 units of basal insulin or lixisenatide. Xultophy 100/3.6 is approved for people with type 2 diabetes who are not achieving glucose goals on less than 50 units of basal insulin or liraglutide. Both Soliqua 100/33 and Xultophy 100/3.6 are administered once daily and come in a pen that is similar to an insulin pen. Like basal insulin, blood glucose levels should be monitored at least once daily in the morning (fasting) and the dose of the medication should be adjusted, if needed, based on fasting glucose values. The exact timing and amount of dose adjustment should be discussed with a healthcare provider.  Precautions and contraindications should also be discussed with a healthcare provider, but in general, both medications have been shown to be very safe and well tolerated in appropriate people with type 2 diabetes.

Soliqua 100/33 is now available in the US and Sanofi, the manufacturer, provides a $0 co-pay card for qualifying commercially insured people as well as a COACH Program that provides support to people using the medication. Information on both programs can be found at soliqua100-33.com.  Xultophy 100/3.6 should be available in the US very soon and the manufacturer, Novo Nordisk, will likely have programs to support its use. Both new fixed-ratio combination products provide people with type 2 diabetes and their providers with a treatment option that is convenient, easy-to-use, and works to safely improve glucose control by combining two medications with different mechanisms of action in one pen device.