| CTRI Number |
CTRI/2026/01/101076 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Understand the effects of Glimepiride, Dapagliflozin and Metformin Combination Tablets in Indian Diabetic Patients |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
UMBRELLA-2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2505009, Version- 01, Dated- 10/06/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lokesh R V |
| Designation |
General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokesh R V |
| Designation |
General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
GUJARAT
380009
India |
| Phone |
917069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Narendra Chouksey |
| Designation |
Assistant General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917069000413 |
| Fax |
|
| Email |
narendrachouksey@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JIGNESH SHETH |
Sarthi Hospital |
1st Floor, Somya Square, Thaltej Road, near Govardhan Party Plot, Opposite Avalon Hotel, Thaltej
Ahmadabad
GUJARAT |
9824249377
drjigneshsheth@yahoo.com |
| Dr AMIT V PATEL |
Shreeji Medical Nursing Home |
17, Vallabhnagar Society, Odhav Rd, G I D C Industrial Area, Odhav
Ahmadabad
GUJARAT |
9825163863
amitvpatel@yahoo.co.in |
| Dr NITIN PARIKH |
Vraj Hospital |
1st Floor, Maruti Nandan Complex, K K Nagar Cross Road, Ghatlodiya
Ahmadabad
GUJARAT |
9825412828
drncp2007@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who were prescribed FDC of Glimepiride, Dapagliflozin, Metformin ER (any dosage) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Change in HbA1c over different time periods |
Baseline and post 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in FPG, PPPG and body weight |
Baseline and post 3 months |
| 2. Safety and tolerability |
Post 3 months |
|
|
Target Sample Size
|
Total Sample Size="25000"
Sample Size from India="25000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
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 |