美国食品药品管理局（FDA）日前批准了一个治疗２型糖尿病的新药，即Tradjenta (linagliptin) 片剂。关于该药，请大家注意以下要点：

　　１、该药虽然可以增加胰岛素的分泌，但仅适合于治疗２型糖尿病；

　　２、不宜用于治疗１型糖尿病；

　　３、最常见的副作用为类似上呼吸道感染症状，如流鼻涕、咽喉部不适、肌肉酸痛和头痛等；

FDA approves new treatment for Type 2 diabetes

　　The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.

People 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.

　　"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology 　Products in the FDA’s Center for Drug Evaluation and Research. “It is effective when used alone or when added to existing treatment regimens.”

　　Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. 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 Type 2 diabetes. 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 Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

　　Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.

　　Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.