A retrosPective Descriptive Analysis Assessing the trEatment peRsistence to baSal InSulin in Type 2 diabEtes patieNTs in a Structured Patient Education Program in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 47,885
- 试验地点
- 1
- 主要终点
- Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month
研究概览
简要总结
The aim of this study is to analyze data from an existing database named SAATH-7 Star, in order to assess the treatment persistence to basal insulin in Type 2 diabetes patients who had been enrolled in the SAATH-7 Star structured patient education program in India.
详细描述
This retrospective study will involve secondary analysis of already existing data of Indian T2DM patients who were administered subcutaneous injectable solutions of insulin glargine (Lantus® or Toujeo®), as per routine clinical practice and who were enrolled in a structured educational program named SAATH-7 Star. Six-months data for eligible patients, who were enrolled in the SAATH-7 Star Program during the index period of March 2019-August 2019, collected from the SAATH-7 Star database will be analyzed for the defined objectives. The index date is defined as the date of enrollment in SAATH-7 Star program i.e. 1st month, which will also be considered as the 'Baseline'
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18 years
- •T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019
排除标准
- •Type 1 diabetes patients
- •Patients with gestational diabetes
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month
时间窗: Month 6
次要结局
- Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month(Month 3)
- Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months(Month 3 and 6)
- Change in Lantus® dose at the end of 3rd and 6th months(Month 3 and 6)
- Change in Toujeo® dose at the end of 3rd and 6th months(Month 3 and 6)
- Proportion of patients on Lantus® who switched to other therapy at the end of 6th month(Month 6)
- Proportion of patients persisting on Lantus® at the end of 3rd and 6th months(Month 3 and 6)
- Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month(Month 6)