The Food and Drug Administration (FDA) has approved Trijardy™ XR (Boehringer Ingelheim and Lilly) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Trijardy™ XR is a once-daily treatment option that combines empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide.
The approval was based on 2 randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin hydrochloride extended-release fixed-dose combination tablets and their individual components in healthy adults. The Company plans to present full data from the open-label trials at an upcoming medical meeting.
Additionally, the approval is supported by a phase 3, randomized, double-blind study that compared the efficacy and safety of empagliflozin plus linagliptin to the individual components as add-on therapy in 686 adult patients with type 2 diabetes who are inadequately controlled on metformin. Patients were randomized 1:1:1:1:1 to receive one of 5 active-treatment arms of empagliflozin 10mg or 25mg, linagliptin 5mg, or linagliptin 5mg in combination with 10mg or 25mg empagliflozin as a fixed-dose combination tablet.
Findings from the study showed that empagliflozin 10mg or 25mg + linagliptin 5mg demonstrated a statistically significant improvement in HbA1c (P <.0001) and fasting plasma glucose (P <.001) compared with the individual components at Week 24. Additionally, a statistically significant reduction in body weight was observed with empagliflozin 10mg or 25mg + linagliptin 5mg compared with linagliptin 5mg alone (P <.0001). No statistically significant difference was observed in body weight compared to empagliflozin alone.
The safety profile of Trijardy™ XR was consistent with its individual components. The most common adverse reactions include upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis. It also carries a Boxed Warning for lactic acidosis.
Ralph DeFronzo, MD, professor and diabetes division chief, UT Health San Antonio commented, “Adding new medicines to an individual’s plan can be challenging for some, which is why new treatment options that can help improve blood sugar without the burden of an increased pill count are important. In addition, type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having 3 different diabetes medications in a single tablet is an important advance in diabetes treatment.”
Trijardy™ XR will be supplied in 4 strengths: 5mg empagliflozin/2.5mg linagliptin/1000mg metformin HCl extended-release; 10mg/5mg/1000mg; 12.5mg/2.5mg/1000mg; and 25mg/5mg/1000mg tablets.