Victoza

诺和诺德公司（普林斯顿，新泽西州）

适应症：
美国食品药物管理局最近批准了Victoza（liraglutide获得[rDNA来源]注射液）的新药申请，第一个也是唯一一次，每天人胰高血糖素样肽1（的GLP - 1）模拟，其中97％的同源性天然的GLP - 1，对2型糖尿病的治疗。 Victoza指示作为辅助饮食和运动改善血液与成人2型糖尿病血糖控制。 Victoza可以单独使用（单一），以及与其他口服抗糖尿病药物的组合。 Victoza工程通过刺激β细胞释放胰岛素只有当血糖水平高，正因为如此，Victoza是一种低血糖低的比率。 Victoza提供每天一次的剂量，不重，在促进广大患者的增益。

剂型：
解皮下注射，预充式，多剂量笔，提供剂量为0.6，1.2或1.8 mg（6毫克/毫升，3毫升）。两个贸易套票数量：2笔调剂1.2毫克剂量的治疗方案，及3笔调剂1.8毫克剂量的治疗方案。

VICTOZA

Indication(s):

As adjunct to diet and exercise, to improve glycemic control in type 2 diabetes.

Pharmacology:

Liraglutide is an analogue of human GLP-1 that acts as an agonist at GLP-1 receptors. Its properties differ from those of the native protein in that it has a longer half-life, enabling it to be dosed once-daily. Its actions include increasing intracellular cAMP, resulting in insulin release in the presence of increased glucose concentrations. This insulin secretion subsides as glucose levels normalize. Liraglutide also decreases glucagon secretion and delays gastric emptying, both of which contribute to its therapeutic effect. It has been shown to reduce fasting, premeal, and postprandial glucose throughout the day.

Clinical Trials:

Five double-blind, randomized, controlled clinical trials were conducted to assess the efficacy of liraglutide in the management of type 2 diabetes. In a 52-week monotherapy trial, 746 patients were randomized to liraglutide 1.2mg or 1.8mg or glimepiride 8mg. Treatment with liraglutide resulted in significant reductions in HbA1c compared to glimepiride.

A 26-week study involving 1091 patients compared three doses of liraglutide (0.6mg, 1.2mg, and 1.8mg), glimepiride 4mg, and placebo as add-on therapy to metformin. The addition of liraglutide 1.2mg and 1.8mg resulted in a significant mean HbA1c reduction compared to placebo and a similar mean HbA1c reduction compared to glimepiride.

In a 26-week study in 1041 patients that compared three doses of liraglutide (0.6mg, 1.2mg, and 1.8mg), rosiglitazone 4mg, and placebo as add-on therapy to glimepiride, treatment with liraglutide 1.2mg and 1.8mg resulted in a significant reduction in mean HbA1c , compared to placebo as add-on to glimepiride.

A 26-week study in 581 patients compared liraglutide 1.8mg, placebo, and insulin glargine as add-on therapy to metformin and glimepiride. Treatment with liraglutide, as add-on to metformin and glimepiride, resulted in significant mean reduction in HbA1c compared to placebo add-on to metformin and glimepiride.

Lastly, a 26-week trial compared liraglutide 1.2mg, liraglutide1.8mg, and placebo as add-on therapy to metformin 2g and rosiglitazone 8mg. Treatment with liraglutide as add-on to metformin plus rosiglitazone resulted in a significant reduction in mean HbA1c , compared to placebo.

Legal Classification:

Rx

Adults:

Give by SC inj in abdomen, thigh, or upper arm once daily. Initially 0.6mg/day for 1 week, then 1.2mg/day; may increase to 1.8mg/day.

Children:

<18yrs: not recommended.

Contraindication(s):

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

Warnings/Precautions:

Not for treating type 1 diabetes or ketoacidosis. Not recommended for first-line treatment in patients inadequately controlled on diet and exercise. Pancreatitis; monitor for signs/symptoms. Renal or hepatic dysfunction. Gastroparesis. Inform patients of thyroid cancer risk and symptoms. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interaction(s):

Concomitant insulin (insufficient data). Hypoglycemia with insulin secretagogues (consider reducing their doses). May affect absorption of other drugs (delayed gastric emptying). Monitor digoxin.

Adverse Reaction(s):

Headache, GI upset, antibody formation, immunogenicity reactions (eg, urticaria), constipation, anorexia; rare: pancreatitis (discontinue if occurs), papillary thyroid carcinoma.

How Supplied:

Multi-dose, prefilled pen (3mL)—2, 3

Last Updated:

3/11/2010

临床实验数据显示，诺和诺德新型糖尿病药Victoza的疗效优于美国默克公司同类产品Januvia，该药是首个每日使用一次的胰高血糖素样肽-1（GLP-1）类似物糖尿病药。
上述临床实验为期26周，共有665位受试者参加。结果表明，2型糖尿病患者用药后，在减少糖化血红蛋白（HbA1C）水平、空腹血糖水平和体重方面效果要比Januvia更胜一筹，后者属二肽基肽酶-4（DPP-4）抑制剂。此外，两相比较，Victoza受试者用药后HbA1C水平降至7%以下的人数几乎是Januvia受试者的两倍。
相关专家表示，大多数患者刚开始使用Victoza时，以1.2毫克作为起始剂量更为合适，但同时他们也指出Januvia价格更为低廉，用药后肠胃副作用也更少，而且Januvia为口服制剂，Victoza则为注射剂，前者使用起来更为方便。
诺和诺德负责人汤姆森表示，目前该公司正将Victoza与各种口服型或注射型糖尿病药进行比较，其中包括礼来/ Amylin的同类产品Byetta。Victoza分别在2009年7月份和今年1月份相继在欧洲和美国获准上市。

注册证号 S20110020
原注册证号 
产品名称（中文） 利拉鲁肽注射液
产品名称（英文） Liraglutide Injection
商品名（中文） 诺和力
商品名（英文） Victoza
剂型（中文） 注射液
规格（中文） 3ml:18mg（预填充注射笔）
注册证号备注 
包装规格（中文） 1支/盒，2支/盒
生产厂商（中文） 丹麦诺和诺德公司
生产厂商（英文） Novo Nordisk A/S
厂商地址（中文） 
厂商地址（英文） Novo Alle, DK-2880 Bagsvaerd, Denmark
厂商国家（中文） 丹麦
厂商国家（英文） Denmark
分包装批准文号 
发证日期 2011-03-04
有效期截止日 2016-03-03
分包装企业名称 
分包装企业地址 
分包装文号批准日期 
分包装文号有效期截止日 
产品类别 生物制品
药品本位码 86978997002256
药品本位码备注 
公司名称（中文） 丹麦诺和诺德公司
公司名称（英文） Novo Nordisk A/S
地址（中文） 
地址（英文） Novo Alle, DK-2880 Bagsvaerd, Denmark
国家（中文） 丹麦
国家（英文） Denmark