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FDA Approves First Oral GLP-1 Treatment for Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes, affecting more than 28 million people in the US.1 It occurs when the pancreas can’t make the insulin needed to maintain normal blood sugar levels.2 GLP-1, or glucagon-like peptide, is a naturally-occurring protein in the body that is often lowered in those with type 2 diabetes.2 GLP-1 helps keep excess sugar from being made by the liver, aids in slowing digestion, and helps the pancreas produce insulin if needed.2 GLP-1 receptor agonists are non-insulin drugs that are effective for people with type 2 diabetes, but their use has been limited because until now, they’ve only been available as injections.

A new drug, Rybelsus (semaglutide), is a GLP-1 drug that is taken orally and has just received approval from the FDA.

How was Rybelsus studied?

The results of 10 PIONEER clinical trials were a factor in the approval of Rybelsus. These trials had over 9,500 participants and the effectiveness of Rybelsus was studied against other drugs like sitagliptin, empagliflozin, and liraglutide, as well as placebo.1 Rybelsus reduced blood sugar (A1C) and was also associated with reduced body weight.1

What is Rybelsus?

Rybelsus is a non-insulin GLP-1 analog in pill form that can be taken orally once daily. It comes in two doses; 7 mg or 14 mg.1 It should be taken at least 30 minutes before the first meal, drink, or medication of the day, with no more of 4 oz of plain water.2 It acts like GLP-1, helping to slow down digestion and maintain normal blood sugar levels.

The most common side effects were nausea, stomach pain, reduced appetite, vomiting, diarrhea, and constipation.1 There is a possible increased risk of thyroid c-cell tumors, and this is not a first-line treatment option.2 This medication is for patients with type 2 diabetes whose blood sugar is not well controlled on their current medications.

If a person has a personal or family history of medullary thyroid carcinoma (MTC), they should not take Rybelsus, along with those who have a history of multiple endocrine neoplasia syndrome type 2 (MEN2).2 There are also potential warnings for pancreatitis, diabetic retinopathy, low blood sugar, and acute kidney injury.

Things to keep in mind

If a person is pregnant or planning to become pregnant, or breastfeeding or planning to breastfeed, the safety of Rybelsus is not known. Those who want to become pregnant should stop taking Rybelsus at least 2 months before trying to get pregnant, and women should not breastfeed while taking the medication.1 If you take any other medications, tell your doctor about medications, vitamins, and any supplements that you take, as Rybelsus may interfere with these.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. FDA Approves Rybelsus (semaglutide), the First GLP-1 Analog Treatment Available Available in a Pill for Adults With Type 2 Diabetes. NovoNordisk. Published September 20, 2019. Accessed September 21, 2019.
  2. FDA Approves First Oral GLP-1 Treatment for Type 2 Diabetes. U.S. Food and Drug Administration. Published September 20, 2019. Accessed September 21, 2019.