Eli Lilly Updates Jentadueto Label To Include Phase 4 Data

Eli Lilly announced that it has successfully updated the label of its Type 2 diabetes drug Jentadueto to include the latest data from a Phase IV trial showing significant blood glucose reductions.

Jentadueto (linagliptin and metformin hydrochloride) is a combination tablet indicated for adults with Type 2 diabetes for improvement of glycemic control when treatment with the two drugs is appropriate. The drug can be used in conjunction with proper diet and exercise to control blood sugar in T2D patients.

The label expansion was based on the positive results of a prospective 24-week, double blind, randomized Phase IV trial in which Jentadueto reduced levels in A1C from baseline compared with linagliptin monotherapy. Secondary findings showed that the combo treatment also significantly decreased fasting plasma glucose (FPG) in participants — a key measure in the study.

Dr. Christophe Arbet-Engels, VP of metabolic clinical development and medical affairs at BIPI, said that they are pleased with the expanded Jentadueto label. “These data support the use of Jentadueto as an initial type 2 diabetes treatment option in an important patient population - treatment-naive adults who have high baseline A1C levels. In addition, these data reinforce the use of Jentadueto, as an adjunct to diet and exercise, in helping adults with type 2 diabetes improve glycemic control.”

The new data was added to the ‘Clinical Studies’ section of Jentadueto’s U.S. prescribing information.

The company also recently announced the U.S. regulatory approval of another diabetes drug it has developed with collaborator Boehringer Ingelheim. Jardiance (empagliflozin) tablets were approved by the Food and Drug Administration (FDA) to control blood sugar as an adjunct to exercise and proper diet in adult patients with Type 2 diabetes.

Diabetes affects approximately 382 million people around the world and an estimated 29 million in the U.S. Type 2 diabetes accounts for 85 to 95 percent of all diabetes cases and results from the body’s inadequacy to produce or use the hormone insulin.