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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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


 
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