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Trajenta for treatment of diabetes mellitus type 2 approved in Europe

Eli Lilly and Boehringer Ingelheim have received marketing authorization from the European Commission for Linagliptin 5 mg film-coated tablets ( Trajenta ) for the treatment of adults with 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.

In the U.S., Linagliptin 5 mg is marketed under the trade name Tradjenta tablets and was approved by the FDA ( Food and Drug Administration ) in May 2011 to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. It has not been studied in combination with Insulin.

Linagliptin has a demonstrated efficacy and safety profile, reducing hemoglobin A1C ( HbA1C or A1C ) levels by a mean of -0.6 to -0.7% ( 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%.
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%.
The incidence of hypoglycemia was similar to placebo and weight did not change significantly from baseline.

In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to that seen with Linagliptin ( 53.8% versus 55.0% ).

The most frequently reported adverse reaction was hypoglycemia observed with the triple combination of Linagliptin plus Metformin plus sulfonylurea.

Source: Eli Lilly, Boehringer Ingelheim, 2011