Jentadueto Label Gets Clinical Trial Data Update
Boehringer Ingelheim and Lilly announced that the U.S. prescribing information for Jentadueto (linagliptin and metformin HCl) now includes new clinical data from a prospective 24-week Phase 4 trial. Jentadueto is a combination of a dipeptidyl peptidase-4 inhibitor and a biguanide indicated as adjunct to diet and exercise in type 2 diabetes.
The randomized, double-blind study evaluated the efficacy and safety of linagliptin 5mg daily in combination with metformin 1500–2000mg daily (n=159) vs. linagliptin 5mg daily (n=157) alone in treatment-naive adults with type 2 diabetes with high baseline A1c (8.5–12%). The primary endpoint was defined as change from baseline in A1c after 24 weeks.
The data showed initial therapy with the combination of linagliptin and metformin reduced A1c levels by 2.9% vs. 2.0% for linagliptin alone. Also, there was a statistically significant mean difference in A1C between the combination and linagliptin alone of -0.84%.
These findings along with key secondary endpoint results have been added to the "Clinical Studies" section of the U.S. prescribing information.
For more information call (800) 243-0127 or visit Jentadueto.com.