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Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

2017年9月1日 更新者:Novo Nordisk A/S

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.

研究概览

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice

描述

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
  • The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
  • Male or female, age at least 18 years at the time of signing the informed consent
  • Patients diagnosed with type 2 diabetes mellitus
  • Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician

Exclusion Criteria:

  • Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
  • Previous participation in this study. Participation is defined as signed informed consent
  • Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
  • Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
  • Patients who are participating in other studies or clinical trials.
  • Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Insulin degludec /liraglutide
Patients will be treated with commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of treatment emergent Adverse Events (AEs)
大体时间:Year 0-1
Count and % of events
Year 0-1

次要结果测量

结果测量
措施说明
大体时间
Number of Serious Adverse Events (SAEs)
大体时间:Year 0-1
Count and % of events
Year 0-1
Number of Serious Adverse Drug Reactions (SADRs)
大体时间:Year 0-1
Count and % of events
Year 0-1
Number of Adverse Drug Reactions (ADRs)
大体时间:Year 0-1
Count and % of events
Year 0-1
Number of confirmed hypoglycaemic episodes
大体时间:Year 0-1
Count of episodes
Year 0-1
Change from baseline in the level of glycosylated haemoglobin (HbA1c)
大体时间:Year 0, Year 1
Measured in %
Year 0, Year 1
Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline
大体时间:Year 0, Year 1
Measured in mg/dl or other equivalent SI units
Year 0, Year 1
Percentage of patients achieving the target level of HbA1c below 7%
大体时间:Year 1
Measured in %
Year 1
Change in body weight
大体时间:Year 0, Year 1
Measured in kg and/or %
Year 0, Year 1
Number of patients withdrawn due to ineffective therapy
大体时间:Year 1
Count of withdrawals
Year 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2017年8月16日

初级完成 (预期的)

2019年3月1日

研究完成 (预期的)

2019年8月16日

研究注册日期

首次提交

2017年2月24日

首先提交符合 QC 标准的

2017年2月28日

首次发布 (实际的)

2017年3月3日

研究记录更新

最后更新发布 (实际的)

2017年9月5日

上次提交的符合 QC 标准的更新

2017年9月1日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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