Skip to main content

FDA approves Trijardy XR for type 2 diabetes

Good news for adults with type 2 diabetes: You have a new treatment option available to lower blood sugar. The U.S. Food and Drug Administration (FDA) announced approval for Trijardy XR. The new triple-combination pill incorporates three diabetes medications in a once-daily prescription:

This pill is not actually a new medication—it’s just a repackaging of three existing therapies, notes Dr. Marie Bellantoni, a board-certified endocrinologist in The Center for Endocrinology at Mercy Medical Center in Baltimore, Maryland.

However, the convenience factor could be very appealing.

“To the extent that anything improves patient adherence to medications is good—the pills don’t work if they don’t get into the patient—then this is helpful,” says Dr. Bellantoni. “Some people feel less overwhelmed if they are taking fewer pills.”

What is Trijardy XR?

Some of the medications contained in Trijardy XR may sound familiar to you, if you or a loved one have type 2 diabetes. You may have taken one or all of these at some point.

Metformin is typically prescribed as a first-line treatment for people with type 2 diabetes. It helps lower blood sugar levels by decreasing your body’s insulin resistance. It also reduces the amount of glucose produced by your liver and your body’s absorption of sugar. Some people take metformin alone, but others must take it along with other diabetes medications.

Tradjenta is designed to help people with type 2 diabetes manage blood sugar levels, along with exercise and diet. It helps to lower blood sugar levels by decreasing the amount of glucose released by the liver and increasing the amount of insulin produced by the pancreas. It’s often prescribed for people who are already taking diabetes medications and making lifestyle changes but still need help to achieve their target A1C. (A1C measures a person’s average blood sugar levels over a three-month span.) It’s also available in a once-daily tablet.

Jardiance is another drug that can help people lower their blood sugar levels along with diet and exercise, but it can also reduce the risk of cardiovascular death in people with type 2 diabetes and heart disease. It’s a once-daily tablet that comes in two formulations (10 mg and 25 mg) and can be taken along with many other medications, including metformin, insulin, beta blockers, ACE inhibitors, and statins.

Trijardy XR dosages

Trijardy XR, marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, will be available in four dosages:

  • 5 mg empagliflozin, 2.5 mg linagliptin, 1000 mg metformin HCl extended-release
  • 10 mg empagliflozin, 5 mg linagliptin, 1000 mg metformin HCl extended-release
  • 12.5 mg empagliflozin, 2.5 mg linagliptin, 1000 mg metformin HCl extended-release
  • 25 mg empagliflozin, 5 mg linagliptin, 1000 mg metformin HCl extended-release

According to the manufacturers, Trijardy XR is the first triple-combination pill to incorporate Jardiance. Jardiance was originally approved by the FDA in 2014, but its approval was expanded in late 2016 to acknowledge its use to reduce the risk of cardiovascular death.

Trijardy XR warnings

Trijardy XR is not intended for people with type 1 diabetes or for people with diabetic ketoacidosis. The manufacturer warns that the drug was not studied in people with pancreatitis, so it’s not recommended for people with that condition. The manufacturer also cautions people who develop signs of metformin-associated lactic acidosis to stop taking the drug immediately. It should also not be used in those with severe kidney issues, end-stage renal disease, or those who are on dialysis. 

 One potential downside of a triple-combination med is it may be more difficult to determine which medication is responsible if you experience an adverse reaction, says Dr. Bellantoni.

“The rational use of a three-drug combination would be after the patient shows efficacy and toleration of the drugs given separately,” she says, “then they really appreciate decreasing the number of prescription refill copays that they have to make.” 

Still, it’s a promising new treatment option. “We believe Trijardy XR has the potential to help adults with type 2 diabetes conveniently manage their treatment, especially those who are taking other medications and working on the necessary lifestyle changes,” Dr. Mohamed Eid, vice president for Clinical Development and Medical Affairs, Cardio-Metabolism and Respiratory Medicine for Boehringer Ingelheim Pharmaceuticals, Inc. said in a statement announcing the approval.