| CTRI Number |
CTRI/2026/03/105948 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study of Empagliflozin and Dapagliflozin in Treating Diabetes |
|
Scientific Title of Study
|
Open label Randomized Controlled Study comparing the Efficacy of Empagliflozin and Dapagliflozin in Prediabetic patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shoaib Ahmad |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University |
| Address |
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India
Aligarh UTTAR PRADESH 202001 India |
| Phone |
09628390593 |
| Fax |
|
| Email |
ahmadshoaib65786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Farida Ahmad |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University |
| Address |
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India
Aligarh UTTAR PRADESH 202001 India |
| Phone |
7417735300 |
| Fax |
|
| Email |
fahmad32@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Farida Ahmad |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University |
| Address |
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India
Aligarh UTTAR PRADESH 202001 India |
| Phone |
7417735300 |
| Fax |
|
| Email |
fahmad32@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Hospital Aligarh Muslim university Aligarh |
|
|
Primary Sponsor
|
| Name |
Shoaib Ahmad |
| Address |
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India |
| Type of Sponsor |
Other [self] |
|
|
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 Farida Ahmad |
jawaharlal nehru medical college and hospital aligarh muslim university |
OPD number 23 and 13
department of medicine and department of nephrology
Aligarh UTTAR PRADESH |
7417735300
fahmad32@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jawaharlal Nehru Medical College & Hospital Faculty Of Medicine Aligarh Muslim University Aligarh Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E169||Disorder of pancreatic internal secretion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin with Standard of Care |
Tablet Dapagliflozin 5mg once a day for three months |
| Intervention |
Empagliflozin with Standerd of Care |
Tablet Empagliflozin 10mg Once a day for three Months |
| Comparator Agent |
Standard of Care |
Weight loss target 5 to 10 percentage if overweight
Physical activity at least 30 min per day
Sleep 6 to 8 hours
Avoid alcohol tobacco stress management education |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years of either gender
Patients diagnosed with Prediabetes Fasting plasma glucose 100 to 125mg per dl or HbA1c 5.7 to 6.4 percent
Patient willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Patients with Uncontrolled Type 2 Diabetes
Patients with eGFR less than 60ml per min per 1.73 meter square
Patients with Cardiovascular Event in Past 6 Months
Patients with Recurrent Urinary Tract Infection or genital mycotic infection
Pregnant or Lactating Women
Patients Taking Glucose Lowering drugs in Past 3 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in HbA1c from baseline to 6 months |
Mean change in HbA1c from baseline to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Achieving Normoglycemia
Changes in BMI waist circumference body composition
change in lipid profile change in HOMA IR index
incidence of ADRs |
over 6 months |
|
|
Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 an open label randomized controlled clinical
trial designed to compare the effects of empagliflozin and dapagliflozin in
adults with prediabetes These medicines are SGLT2 inhibitors that lower blood
sugar by increasing glucose loss through urine and may also improve insulin
sensitivity and body weight Adults with prediabetes who have not used similar
medicines earlier will be enrolled Participants will be randomly assigned into
three groups one group will receive empagliflozin plus standard care one group
will receive dapagliflozin plus standard care and one group will receive
standard care alone control for a fixed study period The main aim is to
evaluate which approach is more effective in improving glycaemic control and
preventing progression to diabetes The primary outcome is change in HbA1c from baseline
to 6 months HbA1c will be measured at baseline 3 months and 6 months Secondary
assessments include changes in body weight lipid profile blood pressure and
insulin resistance HOMA IR Safety will be monitored throughout the study by
regular follow up visits to record any adverse events
Data will be analysed statistically to identify which
group shows better metabolic improvement with fewer adverse effects The
findings may help guide early management of prediabetes and delay the onset of
diabetes using safe and effective therapy |