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)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Torrent Pharmaceuticals Ltd.
- Enrollment
- 25,000
- Locations
- 3
- Primary Endpoint
- 1. Change in HbA1c over different time periods
Overview
Brief Summary
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who were prescribed FDC of Glimepiride, Dapagliflozin, Metformin ER (any dosage).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
1. Change in HbA1c over different time periods
Time Frame: Baseline and post 3 months
Secondary Outcomes
- 1. Change in FPG, PPPG and body weight(Baseline and post 3 months)
- 2. Safety and tolerability(Post 3 months)
Investigators
Dr Lokesh R V
Torrent Pharmaceuticals Ltd.