FDA Approves Tradjenta for Treatment of Type 2 Diabetes


The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Tradjenta (linagliptin) as a medication used along with diet and exercise to lower blood sugar in adult patients.

The drug can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes such as metformin, sulfonylurea or pioglitazone.

Tradjenta belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta is a tablet that can be taken with or without food. Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.

Tradjenta 5 mg once daily was approved based on a clinical trial program which included approximately 4,000 adults with type 2 diabetes. Tradjenta showed statistically significant A1c reductions of up to 0.7 percent when used as monotherapy (compared to placebo). When used in combination with metformin, sulfonylurea, and metformin plus sulfonylurea, the addition of Tradjenta resulted in significant A1c reductions of 0.6, 0.5, and 0.6 percent respectively (compared to placebo). In the initial combination of Tradjenta plus pioglitazone, significant reductions in A1c of 0.5 percent were observed compared to placebo.

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