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CTRI Number  CTRI/2025/02/080295 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Changes in genetic profile with the use of dapagliflozin in people with type 2 diabetes mellitus  
Scientific Title of Study   Alterations in specific circulating microRNAs levels with sodium-glucose co-transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus and albuminuria 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rimesh Pal 
Designation  Faculty 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER) 
Address  Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087007689  
Fax    
Email  rimesh.ben@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rimesh Pal 
Designation  Faculty 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER) 
Address  Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh


CHANDIGARH
160012
India 
Phone  7087007689  
Fax    
Email  rimesh.ben@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rimesh Pal 
Designation  Faculty 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER) 
Address  Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh


CHANDIGARH
160012
India 
Phone  7087007689  
Fax    
Email  rimesh.ben@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India 
 
Primary Sponsor  
Name  None 
Address  Not applicable 
Type of Sponsor  Other [Not applicable as it is not a drug trial] 
 
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 
Rimesh Pal  Postgraduate Institute of Medical Education and Research (PGIMER)  Department of Endocrinology, Room 007, Nehru Hospital Extension, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
Chandigarh
CHANDIGARH 		 7087007689

rimesh.ben@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dapagliflozin  Tablet Dapagliflozin 10 mg would be used in the intervention arm along with ongoing anti-diabetic medications for 12 weeks 
Comparator Agent  Placebo  Matching placebo would be used along with ongoing anti-diabetic medications for 12 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  1. Men aged 40-75 years, duration of T2D more than 2 years, HbA1c at screening 7-10%
2. Urinary albumin-to-creatinine ratio (ACR) more than 30 mg/g, eGFR more than 45 ml/min/1.73 m2
3. On metformin 2000 mg and/or glimepiride 2-4 mg/gliclazide 60-120 mg and/or stable doses of insulin for the last 3 months
4. Non-hypertensive or controlled hypertension on stable dose of anti-hypertensives for the last 6 month 
 
ExclusionCriteria 
Details  1. Coronary artery disease, heart failure, peripheral vascular disease
2. Severe NPDR or PDR or CSME
3. History of urinary tract infection in the past 6 months
4. Prior history of SLGT2i use
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the change in circulating miR-192, miR-200a/200b and miR-191 levels  At the end of 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change in urinary albumin-to-creatinine ratio (ACR) and flow-mediated dilation (FMD)  12 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   18/02/2025 
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="0"
Months="3"
Days="15" 
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   We propose to study the effect of dapagliflozin (a widely used SGLT2i in routine clinical practice) on certain specific microRNAs levels in T2D patients with albuminuria (suggestive of diabetic nephropathy). We plan to conduct a randomized placebo-controlled investigator blinded clinical trial wherein we would recruit 50 T2D men (age 40-75 years) with albuminuria (urinary albumin-to-creatinine ratio (ACR) more than 30 mg/g) and randomly assign them into 2 groups: Group A to receive dapagliflozin 10 mg and standard of care (25) and Group B to receive placebo and standard of care (25). At baseline, HbA1c, urinary ACR, hsCRP, IL6, TNFalpha, flow-mediated dilation (FMD) of the brachial artery (a measure of endothelial dysfunction), and levels of specific circulating miRNAs (miR-192, miR-200a/200b, miR-191; these miRNAs are associated with either albuminuria progression (miR-192) or hyperglycemia-mediated endothelial dysfunction (miR-200a/200b) or hyperglycemia progression in Asian-Indians (miR-191)) would be measured. After 12 weeks of intervention, the same parameters would be re-estimated and compared with the baseline values. Any change in the measured parameters after 12 weeks of intervention could be attributed to the use of dapagliflozin. 
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