The FDA ( Food and Drug Administration ) has approved Tradjenta ( Linagliptin ) tablets, used with diet and exercise, to improve blood glucose control in adults with diabetes mellitus type 2.
Patients with type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase 4 or DPP-4, which leads to better blood glucose control.
Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with diabetes mellitus type 2. The studies showed improvement in blood glucose control compared with placebo.
Tradjenta has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including Metformin, Glimepiride, and Pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with diabetes mellitus type 1 or in those who have increased ketones in their blood or urine ( diabetic ketoacidosis ).
The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.
Source: FDA, 2011
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