FDA approves linagliptin tablets for the treatment of type 2 diabetes

Ingelheim, Germany and Indianapolis, IN, 3 May 2011- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved linagliptin tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. ¹ The FDA has approved linagliptin as a monotherapy or in combination with other commonly prescribed medications for type 2 diabetes—such as metformin, sulphonylurea and pioglitazone — to reduce haemoglobin A1c (HbA1c or A1c) levels by a mean of up to -0.7 percent (compared to placebo). ² HbA1c is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. It is used as a marker of efficacy of antihyperglycaemic therapies.

Linagliptin belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). ¹ With linagliptin, no dose adjustment is recommended for patients with kidney or liver impairment. Linagliptin is a tablet that can be taken with or without food. Linagliptin lowers blood sugar in a glucose-dependent manner by increasing incretin levels (GLP-1), which increase insulin levels after meals and throughout the day. ¹