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德谷胰岛素:一种新型基础胰岛素类似物。

Insulin degludec: a novel basal insulin analogue.

机构信息

School of Pharmacy-Boston, MCPHS University, Boston, MA, USA.

出版信息

Ann Pharmacother. 2013 Feb;47(2):269-77. doi: 10.1345/aph.1R351. Epub 2013 Feb 5.

Abstract

OBJECTIVE

To review the pharmacology, pharmacokinetics, clinical trial data, adverse effects, and potential role in therapy of insulin degludec.

DATA SOURCES

Articles were identified using the MEDLINE database (January 1996-December 2012). Abstracts and posters were identified from respective congressional websites and published supplements of the American Diabetes Association, the European Association for the Study of Diabetes, and the American Association of Clinical Endocrinologists (January 2008-December 2012). Clinicaltrials.gov was used to identify any ongoing clinical trials or completed trials whose results had not been presented or published.

STUDY SELECTION AND DATA EXTRACTION

All available studies were reviewed for inclusion; pharmacokinetic studies were limited to those reporting human data.

DATA SYNTHESIS

Insulin degludec is a novel, ultra-long-acting basal insulin analogue that has a similar safety and efficacy profile when compared with insulin glargine in patients with type 1 or type 2 diabetes. Clinical trials have indicated that there is less hypoglycemia, particularly nocturnal hypoglycemia, associated with this agent.

CONCLUSIONS

If insulin degludec is approved, it may offer an alternative basal insulin for patients needing more flexible dosing, having a history of nocturnal hypoglycemia, or those with severe insulin resistance needing a higher concentration of basal insulin.

摘要

目的

综述德谷胰岛素的药理学、药代动力学、临床试验数据、不良反应以及在治疗中的潜在作用。

资料来源

使用 MEDLINE 数据库(1996 年 1 月至 2012 年 12 月)检索文章。从各自的国会网站和美国糖尿病协会、欧洲糖尿病研究协会和美国临床内分泌医师协会的出版增刊(2008 年 1 月至 2012 年 12 月)中确定摘要和海报。使用 ClinicalTrials.gov 确定任何正在进行的临床试验或已完成但尚未报告或发表结果的试验。

研究选择和数据提取

所有符合条件的研究均进行了综述;药代动力学研究仅限于报告人体数据的研究。

数据综合

德谷胰岛素是一种新型的超长效基础胰岛素类似物,在 1 型或 2 型糖尿病患者中与甘精胰岛素相比具有相似的安全性和疗效。临床试验表明,该药物与低血糖的发生,尤其是夜间低血糖的发生相关度更低。

结论

如果德谷胰岛素获得批准,它可能为需要更灵活给药、有夜间低血糖史或有严重胰岛素抵抗需要更高浓度基础胰岛素的患者提供一种替代基础胰岛素。

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