Boehringer Ingelheim and Eli Lilly announced that the FDA has approved Tradjenta (linagliptin tablets), a dipeptidyl peptidase-4 (DPP-4) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This approval was based on data from a clinical trial program that included approximately 4,000 adults with type 2 diabetes. Tradjenta showed statistically significant HbA1c reductions of up to 0.7% when used as monotherapy, compared with placebo. When used in combination with metformin, a sulfonylurea, and metformin + a sulfonylurea, the addition of Tradjenta resulted in significant HbA1c reductions of 0.6%, 0.5%, and 0.6%, respectively, compared with placebo. In the initial combination of Tradjenta + pioglitazone, significant reductions in A1C of 0.5% were observed, compared with placebo. 

Tradjenta also produced significant reductions in fasting plasma glucose (FPG) and two-hour post-prandial glucose (PPG) levels compared with placebo, when used as monotherapy or in combination with other antidiabetic agents (eg, metformin, sulfonylurea or pioglitazone). In controlled studies, change from baseline in body weight did not differ significantly between groups when Tradjenta was administered as monotherapy, in combination with metformin or in combination with metformin + a sulfonylurea. Patients treated with Tradjenta exhibited a significant mean decrease from baseline body weight compared to a significant weight gain in patients administered a sulfonylurea (-1.1kg vs. +1.4kg. P<0.0001). Patient weight increased in both the Tradjenta + pioglitazone and placebo + pioglitazone groups during the study with an adjusted mean change from baseline of 2.3kg and 1.2kg, respectively (P=0.0141).

Tradjenta is expected to be available in May 2011 in a 5mg dosage strength.

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