诺和诺德称，日本厚生劳动省（MHLW）批准Tresiba用于治疗I型和II型糖尿病。诺和诺德计划定价后将Tresiba在日本上市。这种长效胰岛素类似物的药物申请在美国，欧洲和加拿大也处于审评中。7月，诺和诺德公司称FDA暂定于11月8日召开会议，由内分泌和代谢药物顾问委员会讨论degludec和其复方制剂degludec/门冬胰岛素用于治疗I型和II型糖尿病的新药申请。该复方制剂由70％的degludec和30％的NovoLog（门冬胰岛素）组成。

トレシーバ注 ペンフィル

商標名
TRESIBA Penfill 
 一般名
インスリン デグルデク（遺伝子組換え）［命名法：JAN］
Insulin Degludec (Genetical Recombination)［命名法：JAN］
2. 分子式
C274H411N65O81S6
分子量
6,103.97
構造式

性状
它是一种白色粉末或近白色。
剂量效应和/或使用功效
可用于糖尿病，胰岛素疗法
剂量和用法
通常，在成人中，初始皮下注射一次4-20个单位每天。不断从每天的注射时间。所述剂量适当增加，或根据调查结果和患者的状况下降。会有的胰岛素制剂的组合，虽然其他的维持剂量，包括剂量的胰岛素制剂，而另一个是4到80个单位通常每日。但是，也可使用超出剂量如果必要的。
完整资料附件：http://www.info.pmda.go.jp/go/pack/2492419G1021_1_03/
Tresiba is a once-daily basal insulin analogue with a duration of action beyond 42 hours. It is indicated for use in type 1 and type 2 diabetes.
PHARMACOLOGY
Insulin degludec forms soluble multi-hexamers upon subcutaneous injection, which act as a depot from which insulin monomers are gradually released. These monomers bind to the insulin receptor, resulting in the same pharmacological effects as human insulin.1
The glucose-lowering effect of insulin degludec lasts over 42 hours, allowing flexibility in the time of administration.1
CLINICAL STUDIES
Two phase III, randomised, treat-to-target non-inferiority studies evaluated the safety and efficacy of once-daily insulin degludec in comparison with once-daily insulin glargine, both in combination with mealtime short-acting insulin aspart: BEGIN Basal–Bolus Type 1 trial in patients with type I diabetes and BEGIN Basal–Bolus Type 2 trial in patients with type II diabetes. Participants in the second study also received metformin and/or pioglitazone.2,3
The primary outcome measure was the change from baseline in HbA1c, with a non-inferiority limit of -0.4% for the treatment difference after 52 weeks.2,3
Non-inferior to insulin glargine
The first study recruited patients (n=629) with type I diabetes who had been on a treatment regimen of basal–bolus insulin for at least a year and had an HbA1c ≤10%. After 52 weeks, patients treated with insulin degludec (n=472) experienced a reduction in HbA1c similar to that seen in patients who received insulin glargine (-0.40% vs -0.39%). The treatment difference of -0.01% (95% CI -0.14—0.11) met the prespecified non-inferiority criterion.2
Patients in the second study (n=1,006) had type II diabetes and had received insulin for at least three months before study entry, with an HbA1c of 7.0—10%. Insulin degludec produced a reduction in HbA1c of -1.06%, compared with a reduction of -1.19% with insulin glargine. The treatment difference was 0.08% (95% CI -0.05—0.21), meeting the pre-specified limit for non-inferiority.3
Safety profile
The most frequently reported adverse events in patients receiving insulin degludec were hypoglycaemia and injection site reactions. However, a pre-planned meta-analysis of the safety data from both studies showed that insulin degludec was associated with a lower rate than insulin glargine of overall hypoglycaemia in type II diabetes (estimated risk ratio 0.83) and nocturnal hypoglycaemia in both type I and type II diabetes (estimated risk ratio 0.74).1
No loss of efficacy after 12 months of treatment
A further one-year study, BEGIN Once Long, also compared the efficacy of insulin degludec with insulin glargine, this time both in combination with metformin, in 1,030 insulin-naïve patients with type II diabetes inadequately controlled on oral antidiabetic drugs.4
Insulin degludec was non-inferior to insulin glargine in improving glycaemic control, as indicated by similar reductions in HbA1c (1.06% vs 1.19%), with a treatment difference of 0.09% (95% CI -0.04—0.22). The number of episodes of hypoglycaemia per patient per year was similar in the two groups (1.52 with insulin degludec vs 1.85 with insulin glargine).4
Available in two strengths
Two strengths of Tresiba are available: 100 units/ml and 200 units/ml. These are delivered in two distinct 3ml FlexTouch pen devices: the light green 100 units/ml pen, which delivers insulin in steps of one unit (max 80 units per injection) and is supplied in a five-pen pack; and the dark green 200 units/ml pen, which delivers insulin in steps of two units (max 160 units per injection) and is supplied in a three-pen pack. Both pens have a dose-counter window that shows the exact dose dialled (ie, the number of units that will be injected regardless of strength).
Prescribers should always specify the strength of Tresiba on the prescription and patients should visually identify the strength of Tresiba they are dispensed. Patients should be advised to seek medical advice immediately if they administer an incorrect dose.
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注：以下产品不同规格和价格，详细以咨询为准！
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产地国家: 日本
原产地英文商品名:
Tresiba Flex Touch 100UI/3ml 2kits (cold-storage)
原产地英文药品名:
Insulin degludec
中文参考商品译名:
Tresiba Flex Touch 100UI/3ml 2套 （冷藏）
中文参考药品译名:
胰岛素
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
----------------------------------------------------
产地国家: 日本
原产地英文商品名:
Tresiba Penfil 100UI/3ml 2pens (cold-storage)
原产地英文药品名:
Insulin degludec
中文参考商品译名:
Tresiba Penfil 100UI/3ml 2筆裝（冷藏）
中文参考药品译名:
胰岛素
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
NOVO Nodisk
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产地国家: 日本
原产地英文商品名:
Tresiba Penfil 100mg/ml 3ml 5unit (cold-storage)
原产地英文药品名:
Insulin degludec
中文参考商品译名:
Tresiba Penfil 100毫克/毫升 3毫升 5支（冷藏）
中文参考药品译名:
胰岛素
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
NOVO Nodisk
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产地国家: 日本
原产地英文商品名:
Tresiba injection 100mg/ml 3ml 5 units (cold-storage)
原产地英文药品名:
Insulin degludec
中文参考商品译名:
Tresiba 注射剂 100毫克/毫升 3毫升 5支（冷藏）
中文参考药品译名:
胰岛素
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
NOVO Nodisk
----------------------------------------------------
产地国家: 日本
原产地英文商品名:
Tresiba injection 200mg/ml 3ml 5 units (cold-storage)
原产地英文药品名:
Insulin degludec
中文参考商品译名:
Tresiba 注射剂 200毫克/毫升 3毫升 5支（冷藏）
中文参考药品译名:
胰岛素
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
NOVO Nodisk