Lilly’s New Type 2 Diabetes Drug Receives EU Approval

August 26, 2011

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The  new type 2 diabetes drug Trajenta (linagliptin 5 mg film-coated tablets) received Marketing Authorization from the European Commission for the treatment of type 2 diabetes. The European Commission has approved linagliptin in combination with metformin and metformin plus sulfonylurea. Linagliptin is also approved for use as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.The drug, made by Boehringer Ingelheim and Eli Lilly, was approved by the FDA in May 2011and is marketed in the US under the name Tradjenta.
 
Studies show linagliptin has a demonstrated efficacy and safety profile, reducing hemoglobin A1c (HbA1c or A1c) levels by a mean of -0.6 to -0.7 percent (compared to placebo). A1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months and is used as a marker to determine the efficacy of glucose-lowering therapies.
 
The approval of linagliptin in Europe was based on a clinical trial program which involved approximately 6,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating linagliptin as monotherapy and in combination with the commonly prescribed oral antihyperglycemic medications metformin and/or sulfonylurea. In two monotherapy studies, linagliptin showed a statistically significant mean difference in A1C from placebo of -0.6 to -0.7 percent. In patients who were not adequately controlled on metformin or metformin plus sulfonylurea, the addition of linagliptin also resulted in a statistically significant mean difference in A1c from placebo of -0.6 percent. The incidence of hypoglycemia was similar to placebo and weight did not change significantly from baseline.
 
Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.
 

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