FDA Approves Steglatro for Type 2 Diabetes

One of the newest weapons in the war against Type 2 diabetes[1] is what’s known as an SGLT2 inhibitor[2]. SGLT2 stand for sodium-glucose co-transporter 2, which is a protein that facilitates the reabsorption of glucose, or blood sugar, in the kidneys. That’s fine for most people, but not so great for people with Type 2 diabetes, who don’t need their glucose to be reabsorbed — they need to get rid of excess glucose. Accordingly, SGLT2 inhibitors block the reabsorption of glucose in the kidneys. This increases the excretion of glucose and thus lowers blood glucose levels.

At the most recent meeting of the European Association for the Study of Diabetes, it was announced that a new SGLT2 inhibitor called ertugliflozin (brand name Steglatro) had successfully passed its final trials. The drug companies Merck and Pfizer collaborated on its development, and it had been tested in nine trials involving nearly 13,000 people with Type 2 diabetes. Now, three months later, the U.S. Food and Drug Administration (FDA) has approved ertugliflozin[3] for use in the United States. James Rusnak, MD, PhD, senior vice president and chief development officer, Internal Medicine, Pfizer Global Product Development, said the result of the trials “underscore the potential of ertugliflozin as an important therapeutic option” for adults with Type 2 diabetes. Ertugliflozin comes in two dose sizes, 5 mg (milligrams) and 15 mg, and is meant to be taken once a day, and it is also available in a fixed-dose combination with the medicine sitagliptin (Januvia) under the brand name Steglujan, combining 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin. Steglatro is also approved for use in combination with other drugs, such as metformin[4], a medication widely used to help lower blood sugar, in which case it might be taken twice a day.

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Ertugliflozin is the fourth SGLT2 inhibitor approved for use in the United States. The others are canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance). Evidence additionally exists that SGLT2 inhibitors also benefit heart health[5], and the possibility that ertugliflozin might be effective in Type 1 diabetes[6] is currently being investigated.

Want to learn more about this class of diabetes drug? Read “Diabetes Medicine: SGLT2 Inhibitors.”[7]

Endnotes:
  1. Type 2 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-2-diabetes/
  2. SGLT2 inhibitor: https://www.diabetesselfmanagement.com/blog/diabetes-medicine-sglt2-inhibitors/
  3. has approved ertugliflozin: https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_sglt2_inhibitor_steglatro_ertugliflozin_and_fixed_dose_combination_steglujan_ertugliflozin_and_sitagliptin_for_adults_with_type_2_diabetes
  4. metformin: https://www.diabetesselfmanagement.com/blog/diabetes-medicine-metformin/
  5. heart health: https://www.diabetesselfmanagement.com/managing-diabetes/complications-prevention/fda-oks-two-medicines-cardiovascular-disease-type-2-diabetes/
  6. Type 1 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-1-diabetes/
  7. “Diabetes Medicine: SGLT2 Inhibitors.”: https://www.diabetesselfmanagement.com/blog/diabetes-medicine-sglt2-inhibitors/

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Joseph Gustaitis: Joseph Gustaitis is a freelance writer and editor based in the Chicago area. (Joseph Gustaitis is not a medical professional.)

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