An extension trial comparing safety and efficacy of NN5401 with insulin glargine in subjects with type 2 diabetes (BOOST START 1)

Novo Nordisk AS7 个研究点分布在 1 个国家目标入组 360 人开始时间: 2010年8月14日最近更新: 2018年11月13日

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk AS
入组人数: 360
试验地点: 7
主要终点: Number of treatment emergent adverse events (AEs)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The first enrollement of patients in India is 19 Aug 2010 The number of patients to be recruited in India is 38 Duration of the trial is 28 weeks Duration of treatment with trial product is 26 weeks This is an extension of trial of NN5401-3590 Trial ( Ref: CTRI/2010/091/000044).The study is completed.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Informed consent obtained before any trial-related activities.
•Minimum 18years of age -Must have completed the 26-week treatment period (Visit 28) in trial NN5401-3590.

排除标准

•Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors-Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)-Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements.

结局指标

主要结局

Number of treatment emergent adverse events (AEs)

时间窗: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension)

次要结局

Number of severe and minor treatment emergent hypoglycaemic episodes(after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension))

研究者

发起方

Novo Nordisk AS

申办方类型

Pharmaceutical industry-Global

研究点 (7)

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