FDA approves supplemental NDA for Tradjenta (Boehringer/Eli Lilly) for patients with Type 2 Diabetes

The FDA has approved a supplemental new drug application (sNDA) for Tradjenta (linagliptin), from Boehringer Ingelheim and Eli Lilly, for use as add-on therapy to insulin in patients with Type 2 Diabetes. The FDA's decision is based on data from a 52-week, Phase III trial demonstrating the efficacy of Tradjenta in combination with insulin (with or without metformin and/or pioglitazone). The trial results showed adding Tradjenta to insulin produced better glucose control than insulin alone, with similar incidence of hypoglycemia (low blood sugar) in both treatment groups. Additionally, the FDA-approved label includes a clinical study in people with severe chronic renal impairment. Data from a 52-week, double-blind, randomized, placebo-controlled trial showed that use of Tradjenta 5 mg plus other glucose-lowering therapies in this patient population provided a statistically significant improvement in glycated hemoglobin (HbA1c or A1C) compared to placebo (placebo-adjusted reduction of 0.7 percent).