| CTRI Number |
CTRI/2026/01/100810 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Compare Empagliflozin and Dapagliflozin in Type 2 Diabetes patients taking Metformin |
|
Scientific Title of Study
|
A Comparison of the effectiveness and safety of Empagliflozin and Dapagliflozin in type 2 Diabetes mellites patients already on Metformin - A Prospective Comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen V |
| Designation |
Post graduate |
| Affiliation |
|
| Address |
Department of pharmacology,pg room,Vinayaka missions kirupananda variyar medical college and hospital,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
7845155416 |
| Fax |
|
| Email |
dr.naveen94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Sivasankari |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Vinayaka missions kirupananda variyar medical college and hospital ,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9443515035 |
| Fax |
|
| Email |
drvsivasankari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen V |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Vinayaka missions kirupananda variyar medical college and hospital sankari road ariyanoor salem
Salem
TAMIL NADU
636308
India |
| Phone |
7845155416 |
| Fax |
|
| Email |
dr.naveen94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Vinayaka missions kirupananda variyar medical college and hospital sankari road ariyanoor salem |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naveen v |
Vinayaka Missions Kirupananda Variyar Medical College Hospital |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Sankari Main Road Salem
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Sankari Main Road Salem
Salem
TAMIL NADU |
7845155416
dr.naveen94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab.Dapagliflozin |
25 mg OD for 1 year |
| Comparator Agent |
Tab.Empagliflozin |
10 mg OD for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
around 40 to 75 years of age with both sexes |
|
| ExclusionCriteria |
| Details |
Type I diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in blood glucose level |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in HbA1C |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/02/2026 |
| 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 Applicable |
| 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 cross sectional ,open lapelled study on changes in bood glucose level, hba1c level,with urinay repord for the presence of bacteria ,pus cells and urinary albumin |