First Triple Fixed-dose Combination Pill Approved for T2D

The FDA on Monday, January 27, 2020, approved the first oral treatment for type 2 diabetes (T2D) to combine 3 antihyperglycemic agents: the SGLT2 inhibitor empagliflozin, the DPP-IV inhibitor linagliptin, and metformin hydrochloride extended release. The announcement was made in a joint press release from Boehringer Ingelheim and Eli Lilly and Co.

The 3-in-1 pill, called Trijardy XR, is approved to reduce blood sugar in adults with T2D in combination with changes in diet and exercise.

Approval of the combination pill is based on 2 randomized open-label trials that evaluated in healthy adults the bioequivalence of the 3 components taken in a single pill vs their individual components. The safety profile of  the empagliflozin/linagliptin/metformin HCl XR tablets was found to be consistent with its individual components.

“Many adults living with type 2 diabetes who are already on a treatment plan including multiple medications still struggle to keep their blood sugar under control, and may require additional agents to reach their A1C targets,” said Ralph DeFronzo, MD, professor and diabetes division chief, UT Health San Antonio, in the press release.

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“Having three different diabetes medications in a single tablet, is an important advance in diabetes treatment.” _____________________________________

DeFronzo points out that treatment options that can help patients reach treatment goals without added treatment burden encourage treatment adherence. Optimal T2D  treatment most often requires multiple agents. “Having three different diabetes medications in a single tablet, DeFronzo adds, “is an important advance in diabetes treatment.”

Trijardy XR is contraindicated in individuals with type 1 diabetes or who have end stage renal disease, or are on dialysis, have diabetic ketoacidosis or are allergic to empagliflozin, linagliptin, metformin, or any of the ingredients in Trijardy XR.

“We developed Trijardy XR because many people with type 2 diabetes need help managing this complex condition without adding more pills to their treatment plan. We look forward to making this new option available soon,” said Jeffrey Emmick, MD, PhD, vice president of product development at Lilly, in the press release.

Trijardy XR will be available in four dosages:

• 5 mg empagliflozin/2.5 mg linagliptin/1,000 mg metformin hydrochloride ER

• 10 mg empagliflozin/5 mg linagliptin/1,000 mg metformin hydrochloride ER

• 12.5 mg empagliflozin/2.5 mg linagliptin/1,000 mg metformin hydrochloride ER

• 25 mg empagliflozin/5 mg linagliptin/1,000 mg metformin hydrochloride ER

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