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临床试验/NCT01400971
NCT01400971已完成不适用

A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 4,299 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,299
试验地点
1
主要终点
Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy

研究概览

简要总结

The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have been diagnosed with type 2 diabetes
  • Have presented within the normal course of care
  • Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications)
  • Are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
  • Have been fully informed and have given written consent for the use of their data
  • Have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
  • Have not initiated basal bolus therapy (three mealtime insulin injections)

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy

时间窗: Baseline through 24 months

Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey \[IPC\] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.

次要结局

  • Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study(Baseline through 24 months)
  • Number of Hypoglycemic and Severe Hypoglycemic Episodes(Baseline through 24 months)
  • Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)(Baseline through 24 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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