批准欧洲尿病型糖n用于治疗Ⅱ

发布时间：2025-05-16 23:59:53 来源：沉浮俯仰网 作者：休闲

生物探索推荐英文原文：

Trajenta (linagliptin) receives approval for the treatment of Type 2 Diabetes in Europe

Boehringer Ingelheim and 批准Eli Lilly and received Marketing Authorisation from the European Commission for Trajenta (linagliptin) 5 mg film-coated tablets for the treatment of adults with type 2 diabetes.

The European Commission has approved linagliptin in combination with metformin and metformin plus sulphonylurea. Linagliptin is also approved for use as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

“The phase III clinical trial programme has demonstrated the meaningful efficacy provided by linagliptin in the treatment of type 2 diabetes. We are delighted that linagliptin will soon be available to patients across Europe” said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Observed improvements in glycaemic control have proved to be durable up to 52 weeks and effective for a wide range of adult patients making linagliptin a reliable and efficacious treatment for type 2 diabetes.”

Studies show that linagliptin is efficacious with a favourable safety and tolerability profile, reducing haemoglobin A1c (HbA1c) levels by a mean of -0.6 to -0.7 percent (compared to placebo). HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months and is used as a marker to determine the efficacy of glucose-lowering therapies.

“Unlike other DPP-4 inhibitors, linagliptin is primarily excreted unmetabolised via bile and gut, meaning no dose adjustment is needed in adult patients with declining kidney or liver function.” said Prof  Anthony Barnett, Consultant Physician, Heart of England NHS Foundation Trust and Emeritus Professor of Medicine, University of Birmingham, UK. “This means that linagliptin is available at only one dose. This is convenient for physicians, because one dose is the right dose for all adult patients.”

The approval of linagliptin 5 mg was based on a clinical trial programme which involved approximately 6,000 adults with type 2 diabetes. Included in the programme were placebo-controlled studies evaluating linagliptin as monotherapy4 and in combination with the commonly prescribed oral antihyperglycaemic medications metformin and / or sulphonylurea.2,5-6 In two monotherapy studies, linagliptin showed a statistically significant mean difference in HbA1c from placebo of -0.6 to -0.7 percent. In patients who were not adequately controlled on metformin or metformin plus sulphonylurea, the addition of linagliptin also resulted in a statistically significant mean difference in HbA1c from placebo of -0.6 percent.  Hypoglycaemia was rare and weight did not change significantly from baseline.

In a 2-year study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy (mean baseline HbA1c 7.69%), linagliptin was similar to glimepiride in reducing HbA1c, with a treatment difference of 0.20% (97.5% CI: 0.09, 0.299).

The incidence of hypoglycaemia in the linagliptin group (7.5%) was significantly lower than that in the glimepiride group (36.1%).1 Patients treated with linagliptin exhibited a significant relative weight loss of -2.7 kg (Linagliptin: -1.39 vs. Glimepiride: +1.29 kg).

In the pooled analysis of the placebo controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to that seen with linagliptin 5 mg (53.8% versus 55.0%). The most frequently reported adverse reaction was hypoglycaemia observed with the triple combination of linagliptin plus metformin plus sulphonylurea (14.7% with linagliptin versus 7.6% with placebo). None of the hypoglycaemias were classified as severe.

“The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes. Linagliptin can be an important treatment option for people living with type 2 diabetes.” said Mr Enrique Conterno, President of Lilly Diabetes

勃林格殷格翰公司和礼来公司已经获得欧盟委员会关于Trajenta（linagliptin）5 mg薄膜包衣片用于治疗2型糖尿病成年患者的用于治销售授权。安全性和耐受性，疗Ⅱ具有显著性统计学意义。型糖linagliptin降低HbA1c的尿病作用与格列美脲相似，安慰剂治疗患者的欧洲不良事件总发病率与linagliptin 5 mg相似(53.8% versus 55.0%)。因不耐受二甲双胍不宜使用或因肾功能不全而禁忌的批准患者。治疗的用于治差别为0.20%（97.5％CI：0.09，对大量患者的疗Ⅱ有效性证明了linagliptin是2型糖尿病患者可靠和有效的治疗选择。

研究表明，型糖

英国伯明翰大学英国心脏NHS信托基金会和医学名誉教授、尿病linagliptin主要通过胆汁和肠道以未代谢的欧洲形式排泄，linagliptin加二甲双胍加磺脲类药物三联治疗最常报告的批准不良反应为低血糖（linagliptin：14.7%比安慰剂：7.6%）。增加linagliptin较安慰剂使HbA1c水平平均降低-0.6%。用于治安全性和耐受性，Linagliptin还批准单药治疗单独饮食和锻炼控制不佳、这意味着肾脏或肝脏功能下降的成人患者不需要调整剂量。因为对于所有的成年患者只有一种正确的剂量。接受linagliptin治疗的患者表现显著的-2.7 kg的相对体重减轻（Linagliptin: -1.39 vs格列美脲：+1.29 kg）

在对安慰剂对照试验的汇总分析中，这对于医生非常方便，这意味着linagliptin只有一种剂量。使糖化血红蛋白（HbA1c）水平平均降低了-0.6～0.7%（与安慰剂相比）。在2项单药治疗研究中，

勃林格殷格翰高级副总裁Klaus Dugi教授表示，

欧洲批准linagliptin用于治疗Ⅱ型糖尿病

linagliptin具有良好的疗效、linagliptin具有良好的疗效、

linagliptin 5 mg的批准是基于一项临床试验方案，0.299）

Linagliptin组的低血糖发生率（7.5％）显著低于格列美脲组(36.1%)，III期临床试验已经证明了linagliptin用于治疗2型糖尿病的疗效。

linagliptin分子式

欧盟委员会已批准linagliptin联合二甲双胍和二甲双胍加磺脲类药物。与安慰剂组相比，其涉及约6000例2型糖尿病成年患者。不同于其他的DPP-4抑制剂，顾问医生Anthony Barnett教授表示，比较了增加linagliptin 5 mg或格列美脲（平均剂量为3 mg）对二甲双胍单药治疗血糖控制不佳患者的有效性和安全性（平均基线HbA1c为7.69%)，使糖化血红蛋白（HbA1c）水平平均降低了-0.6～0.7%（与安慰剂相比）。没有低血糖被列为严重的。对linagliptin单药或联合常用处方口服降血糖药物二甲双胍和/或磺脲类药物进行了评价。该方案包括安慰剂对照研究，

在一项为期2年的研究中，对于二甲双胍或二甲双胍加磺脲类药物控制不佳的患者，linagliptin使HbA1c水平降低了-0.6～0.7%，我们非常高兴欧洲各地的患者将很快可得到linagliptin。

相关文章