Tradjenta Approved for Type 2 Diabetes
Tradjenta (linagliptin tablets), a dipeptidyl peptidase-4 (DPP-4) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This approval was based on data from a clinical trial program that included approximately 4,000 adults with type 2 diabetes. Tradjenta showed statistically significant HbA1c reductions of up to 0.7% when used as monotherapy, compared with placebo. When used in combination with metformin, a sulfonylurea, and metformin + a sulfonylurea, the addition of Tradjenta resulted in significant HbA1c reductions of 0.6%, 0.5%, and 0.6%, respectively, compared with placebo. In the initial combination of Tradjenta + pioglitazone, significant reductions in A1C of 0.5% were observed, compared with placebo. 

Tradjenta also produced significant reductions in fasting plasma glucose (FPG) and two-hour post-prandial glucose (PPG) levels compared with placebo, when used as monotherapy or in combination with other antidiabetic agents (eg, metformin, sulfonylurea or pioglitazone). In controlled studies, change from baseline in body weight did not differ significantly between groups when Tradjenta was administered as monotherapy, in combination with metformin or in combination with metformin + a sulfonylurea. Patients treated with Tradjenta exhibited a significant mean decrease from baseline body weight compared to a significant weight gain in patients administered a sulfonylurea (-1.1kg vs. +1.4kg. P<0.0001). Patient weight increased in both the Tradjenta + pioglitazone and placebo + pioglitazone groups during the study with an adjusted mean change from baseline of 2.3kg and 1.2kg, respectively (P=0.0141).
Tradjenta is expected to be available in May 2011 in a 5mg dosage strength.

美国批准一种治疗Ⅱ型糖尿病口服药片Tradjenta上市
美国药管局表示，在约3800名Ⅱ型糖尿病患者参与的8项双盲临床试验中，这种药物的安全性和有效性得到展现，其主要副作用包括上呼吸道感染、流鼻涕、喉咙痛、肌肉痛和头痛等。
美国食品和药物管理局2日批准一种治疗Ⅱ型糖尿病的口服药片Tradjenta（通用名“利拉利汀”）上市，利拉利汀可用于改善Ⅱ型糖尿病患者血糖控制能力。
Ⅱ型糖尿病又称成年发病型糖尿病，是最常见的糖尿病，其特点是胰岛素抵抗，即自体能够产生胰岛素，但体内组织对胰岛素的作用不敏感，正常量的胰岛素起不到正常的降血糖作用。利拉利汀通过抑制二肽基肽酶－4，提高一种激素的水平，而这种激素可刺激胰岛素释放，进而改善服用者的血糖控制。
美国药管局表示，在约3800名Ⅱ型糖尿病患者参与的8项双盲临床试验中，这种药物的安全性和有效性得到展现，其主要副作用包括上呼吸道感染、流鼻涕、喉咙痛、肌肉痛和头痛等。
利拉利汀由位于美国康涅狄格州的勃林格殷格翰制药公司出品，可单独服用，也可与其他现有药物联合使用。

Tradjenta
Generic Name: linagliptin
Date of Approval: May 2, 2011
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company
Treatment for: Type 2 Diabetes
Why managing blood sugar is so important.
.The U.S. Food and Drug Administration (FDA) has approved Tradjenta (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Tradjenta can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. Tradjenta 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.
Tradjenta belongs to a class of prescription medications called d