The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for an investigational triple combination tablet for the treatment of adults with type 2 diabetes.
The product combines empagliflozin, a sodium glucose co-transporter-2 (SLGT-2) inhibitor, linagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4), and metformin, a biguanide. The NDA includes data from 2 randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin XR combination tablets and their individual components in healthy adults. Results from the trials will be presented at a medical congress later this year.
“If approved by the FDA, the combination tablet would be one of the first single-pill options with 3 complementary mechanisms of action to help manage blood glucose in adults with type 2 diabetes who could benefit from having empagliflozin and linagliptin as part of their treatment regimen, in addition to metformin.”
Empagliflozin works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels. Linagliptin increases the concentration of active incretin hormones, which stimulates the release of insulin in a glucose-dependent manner and decreases the levels of glucagon in the circulation. Metformin improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial glucose.