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(利拉利汀[linagliptin])片
Manufacturer:
Boehringer Ingelheim and Lilly
Pharmacological Class:
Dipeptidyl peptidase-4 inhibitor (DPP-4).
Active Ingredient(s):
Linagliptin 5mg; tabs.
Indication(s):
Adjunct to diet and exercise in type 2 diabetes mellitus, as monotherapy or combination therapy.
Pharmacology:
Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation.
Clinical Trials:
Linagliptin was studied in approximately 3800 patients with type 2 diabetes in 8 double-blind, placebo-controlled safety and efficacy trials.
A total of 730 patients participated in two studies, one of 18-week and another of 24-week duration, to evaluate the efficacy and safety of linagliptin monotherapy. Treatment with linagliptin 5mg daily provided statistically significant improvements in A1C, FPG, and 2-hour PPG compared with placebo.
A total of 701 patients participated in a 24-week study designed to assess the efficacy of linagliptin in combination with metformin. In combination with metformin, linagliptin provided statistically significant improvements in A1C, FPG, and 2-hour PPG compared with placebo.
The efficacy of linagliptin is being evaluated in a 104-week double-blind, glimepiride-controlled non-inferiority study in type 2 diabetic patients with insufficient glycemic control despite metformin therapy. After 52 weeks, linagliptin and glimepiride both had reductions from baseline in A1C (-0.4% for linagliptin, -0.6% for glimepiride) from a baseline mean of 7.7%.
A total of 389 patients participated in a 24-week study designed to assess the efficacy of linagliptin in combination with pioglitazone. In initial combination with pioglitazone 30mg, linagliptin 5mg provided statistically significant improvements in A1C and FPG compared to placebo with pioglitazone.
A total of 245 patients participated in an 18-week study designed to assess the efficacy of linagliptin in combination with a sulfonylurea. In combination with a sulfonylurea, linagliptin provided statistically significant improvements in A1C compared with placebo following 18 weeks treatment; the improvements in FPG observed with linagliptin were not statistically significant compared with placebo.
A total of 1058 patients participated in a 24-week study designed to assess the efficacy of linagliptin in combination with a sulfonylurea and metformin. In combination with a sulfonylurea and metformin, linagliptin provided statistically significant improvements in A1C and FPG compared with placebo.
Legal Classification:
Rx
Adults:
5mg once daily.
Children:
Not recommended.
Warnings/Precautions:
Not for the treatment of type 1 diabetes or diabetic ketoacidosis. Pregnancy (Cat. B). Nursing mothers.
Interaction(s):
Antagonized by strong P-gp or CYP3A4 inducers (eg, rifampin); consider alternatives to linagliptin if used in combination. Concomitant sulfonylurea: may need lower dose of sulfonylurea to reduce risk of hypoglycemia. Concomitant insulin: not studied.
Adverse Reaction(s):
Nasopharyngitis, hypoglycemia, arthralgia, back pain, headache; hypersensitivity reactions (eg, urticaria, angioedema, localized skin exfoliation, bronchial hyperreactivity), myalgia, pancreatitis.
How Supplied:
Tabs—30, 90, 1000