A retrospective multicenter observational study to assess the effectiveness and tolerability of fixed dose combination of glimepiride, dapagliflozin and metformin in type 2 Diabetes mellitus in Indian patients (UMBRELLA-2)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25,000
- 试验地点
- 3
- 主要终点
- 1. Change in HbA1c over different time periods
研究概览
简要总结
This is a Real world, retrospective, multicentric, observational study wherein data of patients visiting to various clinics across India are collected in suitably designed Data Collection Form (DCF).
The objective of the study is to retrospectively understand the efficacy and tolerability of Glimepiride, Dapagliflozin, Metformin ER FDCs in the management of T2DM, in real world outpatient settings of India.
- Patients who were prescribed FDC of Glimepiride, Dapagliflozin, Metformin ER (any dosage) will be included for the study.
The endpoints of the study are as follows-
- Primary Endpoints:
- Change in HbA1c over different time periods
- Secondary Endpoints:
-
Change in FPG, PPPG and body weight
-
Safety and tolerability
The present study is a retrospective data collection study. Basic statistical analysis will be performed on all collected data. The data will be compiled, and subjected to analysis
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who were prescribed FDC of Glimepiride, Dapagliflozin, Metformin ER (any dosage).
排除标准
- 未提供
结局指标
主要结局
1. Change in HbA1c over different time periods
时间窗: Baseline and post 3 months
次要结局
- 1. Change in FPG, PPPG and body weight(Baseline and post 3 months)
- 2. Safety and tolerability(Post 3 months)
研究者
Dr Lokesh R V
Torrent Pharmaceuticals Ltd.