August 20, 2012
Boehringer and Lilly Announce sNDA Approval for Tradjenta
The FDA's approval is based on data from a 52-week, Phase 3 trial demonstrating the efficacy of Tradjenta in combination with insulin (with or without metformin and/or pioglitazone). At 24 weeks, Tradjenta plus basal insulin demonstrated a placebo-adjusted reduction in hemoglobin A1C of 0.65% from a baseline A1C of 8.3%. The rate of hypoglycemia also was similar in both groups (21.4% in Tradjenta vs. 22.9% in placebo).
Tradjenta was also studied in people with severe chronic renal impairment. Data from a 52-week, double-blind, randomized, placebo-controlled trial showed that use of Tradjenta 5mg plus other glucose-lowering therapies in this patient population after 12 weeks of treatment showed statistically significant improvements in A1C with an adjusted mean change of -0.6%, compared to placebo. Efficacy was
maintained for 52 weeks with an adjusted mean change from baseline in A1C of -0.7%, compared to placebo.
Tradjenta, a dipeptidyl peptidase-4 inhibitor, is already indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus as monotherapy or combination with
metformin, sulfonylurea, or pioglitazone. Tradjenta acts by increasing incretin levels, stimulating the release of insulin in a glucose-dependent manner.
For more information call (800) 542-6257 or visit www.tradjenta.com.