2011年5月2日，美国食品与药物管理局（FDA）发布公告，批准Tradjenta（活性成分linagliptin）片剂结合运动与饮食控制一起，用于改善成人2型糖尿病患者的血糖控制。
2型糖尿病患者体内不产生胰岛素或对胰岛素失去正常反应。胰岛素是一种调节血液中葡萄糖含量的激素。随着时间推移，高血糖水平会增加严重并发症的风险，包括心脏病、失明、神经和肾脏受损。
2型糖尿病是糖尿病最常见的一种类型，在美国2400万糖尿病患者中占到90%—95%。Tradjenta可增加激素水平，通过阻断二肽基肽酶-4（DPP-4）刺激饭后胰岛素释放，从而使血糖得到更好的控制。

制造商：
勃林格殷格翰公司和礼来公司

类药物：
二肽基肽酶4抑制剂（DPP - 4）。

活性成分（S）：
Linagliptin毫克;选项卡。

指示（S）：
兼任作为单一疗法或联合疗法在2型糖尿病的饮食和运动。

药理学：
Linagliptin是DPP - 4抑制剂，酶，降解肠促胰岛素激素，胰高血糖素样肽1（GLP - 1）和葡萄糖依赖性促胰岛素多肽（GIP）。因此，linagliptin增加活跃的肠促胰岛素激素的浓度，刺激葡萄糖依赖性胰岛素释放和减少胰高血糖素的水平，在流通。

临床试验：
在约3800 8双盲，安慰剂对照的安全性和有效性试验与2型糖尿病患者进行了研究Linagliptin。

共有730名病人参加了两项研究，18周和24周时间，以评估linagliptin单药治疗的疗效和安全性。每日linagliptin毫克治疗提供了显着改善糖化血红蛋白，空腹血糖，2小时PPG与安慰剂相比。

共有701例患者参加了一个24周的研究，旨在评估linagliptin疗效与二甲双胍联合。与二甲双胍结合，linagliptin提供显着改善糖化血红蛋白，空腹血糖，2小时PPG与安慰剂相比。

linagliptin的疗效正在评估一项为期104周双盲，格列美脲控制非劣尽管二甲双胍治疗血糖控制不足的2型糖尿病患者的研究中。后52周，linagliptin和格列美脲都在糖化血红蛋白（linagliptin为-0.4％，-0.6％，为格列美脲）从基线，从基线减少，平均为7.7％。

共有389例患者参加了一个为期24周的研究，旨在评估linagliptin疗效与吡格列酮组合。在最初的组合与吡格列酮30毫克，linagliptin毫克提供了显着改善糖化血红蛋白和空腹血糖相比，吡格列酮的安慰剂。

共有245例患者参加了为期18周的研究旨在评估linagliptin疗效与磺脲类结合。在与磺脲类相结合，linagliptin提供糖化血红蛋白显着改善，与安慰剂18周的治疗后相比，linagliptin观察台塑的改善，与安慰剂相比无显着性。

共有1058例患者参加了一个24周的研究旨在评估linagliptin疗效与磺脲类和二甲双胍结合。磺脲类和二甲双胍的组合，linagliptin提供糖化血红蛋白和空腹血糖显着改善，与安慰剂相比。

法律分类：
接收

成人：
5毫克，每日一次。

儿童：
不推荐。

警告/注意事项：
不适用于治疗1型糖尿病或糖尿病酮症酸中毒。怀孕（乙部件）。哺乳的母亲。

相互作用（S）：
拮抗强大的P -糖蛋白或CYP3A4诱导剂（如利福平）;考虑到linagliptin的替代品，如果结合使用。伴随磺脲类：可能需要低剂量磺脲类，以减少低血糖的风险。伴随胰岛素：没有研究过。

不良反应（S）：
鼻咽炎，低血糖，关节痛，腰背痛，头痛，过敏反应（如荨麻疹，血管神经性水肿，局部皮肤剥脱，支气管高反应性），肌痛，胰腺炎。

如何提供：
标签- 30，90，1000

最后更新：
2011年6月16日

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。
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。

Linagliptin联合二甲双胍具有多重疗效优势

日前，勃林格殷格翰公司与礼来公司共同宣布了linagliptin(将以Trajenta为商品名在欧洲上市)的临床研究结果：该药应用于血糖未获满意控制的成年2型糖尿病(T2D)治疗，可改善患者的血糖控制情况。

一项超过两年的Ⅲ期临床研究，目的在于评估在接受稳定的二甲双胍治疗(给药剂量至少为1500mg/d，治疗时间至少达到10周)但血糖水平未获满意控制的成年2型糖尿病患者中，加用linagliptin或格列美脲的长期疗效和安全性。其疗效终点是糖化血红蛋白(HbA1c)相较基线水平的改变；关键性的次要终点评估了低血糖事件发生率和体重随时间的变化；另一个安全性终点评估了事先设定的、前瞻性、经研究者判定的心血管(CV)事件。研究中，HbA1c检测显示，linagliptin在降糖疗效方面与格列美脲相当。此外，相较格列美脲治疗组，linagliptin治疗组出现体重下降(-1.4kgvs. +1.5kg，调整后的平均差异为-2.9kg；p<0.0001)、更低的低血糖发生率(7.5% vs. 36.1%；p<0.0001)和更少的心血管事件(1.7% vs. 3.4%；相对危险度为0.46 [0.23-0.91] p=0.02)。

“linagliptin加二甲双胍的联合治疗与磺脲类药物加二甲双胍的联合治疗相比，能够产生相似的具有临床意义的降糖效果。所获得的额外受益是，与磺脲类药物不同，linagliptin治疗不增加体重，而且linagliptin治疗本身不增加低血糖的发生。”勃林格殷格翰公司总部高级医学副总裁Klaus Dugi教授说，“此项研究还证实，与磺脲类药物格列美脲相比，linagliptin治疗还可降低54%的心血管事件相对危险度，这也是迄今为止观察到的linagliptin在心血管安全性潜在优势方面的又一亮点，我们正在通过CAROLINA研究对此进行进一步证实。”

另一项为期24周的linagliptin研究显示，linagliptin 2.5mg每日两次联合二甲双胍1000mg每日两次应用于血糖水平未获满意控制的成年2型糖尿病患者时，安慰剂校正后的HbA1c均值出现相较基线水平达1.7%的下降。Linagliptin联合二甲双胍相较两种药物单独使用，具有良好的耐受性和更为优化的血糖控制效果。在此项研究中，linagliptin加二甲双胍的联合治疗组未观察到体重增加，而且低血糖发生风险极低(5例，占患者总数的1.8%)。在一项针对血糖控制不佳(基线HbA1c>11%)患者的开放标记研究中，linagliptin 2.5mg每日两次联合二甲双胍1000mg每日两次，可使患者的HbA1c水平下降3.7%。

在伴有不同肾功能水平的成年2型糖尿病患者应用Linagliptin的评估方面，一项基于三项随机、安慰剂对照Ⅲ期临床研究(n=2141)的大型汇总分析显示，在接受linagliptin治疗的不同肾功能水平的成年2型糖尿病患者患者中，观察到稳定可靠的安慰剂校正后HbA1c平均降幅，而且不依赖于肾功能水平：在肾功能正常患者中为-0.63%(p<0.0001)，在伴有轻度和中度肾功能受损的患者中为-0.69%(p<0.0001，p=0.0174)。在另外一项针对伴有重度肾功能受损(RI)、血糖水平未获满意控制的成年2型糖尿病的研究中，为期12周的linagliptin治疗可产生具有临床意义的安慰剂校正后HbA1c降幅，降幅为-0.6%(p<0.0001)。在两个治疗组中，患者的肾功能均保持稳定；在高风险患者中，CV死亡发生率较低，每组仅发生1例。

“肾功能下降是与2型糖尿病相关的常见并发症，也是限制降糖药物使用的主要因素。”澳大利亚Baker IDI心脏病和糖尿病研究所副主任、首席科学家Mark Cooper博士评价道，“在此项研究中，linagliptin显示了优异的肾脏安全性，并能有效降低HbA1c，甚至在伴有肾脏并发症的晚期2型糖尿病患者中也是如此。

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 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). With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta is a tablet that can be taken with or without food. Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day
Tradjenta Patient Information
Read this Patient Information before you start taking Tradjenta and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Tradjenta?
•Tradjenta is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
•Tradjenta is not for people with type 1 diabetes.
•Tradjenta is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
•It is not known if Tradjenta is safe and effective when used with insulin.
•It is not known if Tradjenta is safe and effective in children.
Home › Drugs by Condition › D › Diabetes, Type 2 › Tradjenta Consumer Information
   Print | Save or Share 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

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FDA Approves Tradjenta
Related Video
 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 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). With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta is a tablet that can be taken with or without food. Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.

Tradjenta Patient Information
Read this Patient Information before you start taking Tradjenta and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Tradjenta?
•Tradjenta is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
•Tradjenta is not for people with type 1 diabetes.
•Tradjenta is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
•It is not known if Tradjenta is safe and effective when used with insulin.
•It is not known if Tradjenta is safe and effective in children.
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Who should not take Tradjenta?
Do not take Tradjenta if you:

•are allergic to linagliptin or any of the ingredients in Tradjenta. See the end of this leaflet for a complete list of ingredients in Tradjenta.
Symptoms of a serious allergic reaction to Tradjenta are:

◦rash
◦raised red patches on your skin (hives)
◦swelling of your face, lips, and throat that may cause difficulty breathing or swallowing
Before using Tradjenta
Before you take Tradjenta, tell your doctor if you:

•have any other medical conditions
•are pregnant or planning to become pregnant. It is not known if Tradjenta will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
•are breastfeeding or plan to breastfeed. It is not known if Tradjenta passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Tradjenta.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tradjenta may affect the way other medicines work, and other medicines may affect how Tradjenta works.

Especially tell your doctor if you take

•other medicines that can lower your blood sugar
•rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis
Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Tradjenta?
•Take Tradjenta one time each day exactly as your doctor tells you to take it.
•Talk with your doctor if you do not understand how to take Tradjenta.
•Your doctor will tell you when to take Tradjenta.
•Take Tradjenta with or without food.
•If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
•Do not take two doses of Tradjenta at the same time.
•Your doctor may tell you to take Tradjenta along with other diabetes medicines. Low blood sugar can happen more often when Tradjenta is taken with certain other diabetes medicines. See Tradjenta side effects
•If you take too much Tradjenta, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
•When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
•Check your blood sugar as your doctor tells you to.
•Stay on your prescribed diet and exercise program while taking Tradjenta.
•Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
•Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
Tradjenta side effects
Tradjenta may cause serious side effects, including:

•low blood sugar (hypoglycemia). If you take Tradjenta with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take Tradjenta.
Signs and symptoms of low blood sugar may include:

◦headache
◦drowsiness
◦weakness
◦dizziness
◦confusion
◦irritability
◦hunger
◦fast heart beat
◦sweating
◦feeling jittery
The most common side effects of Tradjenta include:

•stuffy or runny nose and sore throat
Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tradjenta. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Tradjenta?
•Store Tradjenta at 59°F to 86°F (15°C to 30°C).
Keep Tradjenta and all medicines out of the reach of children.

General information about the safe and effective use of Tradjenta.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Tradjenta for a condition for which it was not prescribed. Do not give Tradjenta to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes the most important information about Tradjenta. If you would like more information, talk with your doctor.

You can ask your pharmacist or doctor for information about Tradjenta that is written for health professionals.

For more information, go to www.tradjenta.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in Tradjenta?
Active Ingredient: linagliptin

Inactive Ingredients: mannitol, pregelatinized starch, corn starch, copovidone, and magnesium stearate. The film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and red ferric oxide.

What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and or the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar to a normal level. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.