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CTRI Number  CTRI/2024/02/063292 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessment of effectiveness of Empagliflozin in the management of Anemia in diabetes patients 
Scientific Title of Study   Assessment of Effectiveness of Empagliflozin in the Management of Anemia in Type 2 Diabetes Patients with Early Stage of Chronic Kidney Disease- A Prospective Randomised COntrol 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 Kumar J S 
Designation  Physician 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of General Medicine,Room no.4 Diabetic Clinic SRM Medical College Hospital and Research Centre, Potheri SRM Nagar, Kattankulathur Chengalpattu

Kancheepuram
TAMIL NADU
603203
India 
Phone  7397353836  
Fax    
Email  hod.genmed.ktr@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Jagadeesan 
Designation  Assistant Professor 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Pharmacy Practice SRM college Of Pharmacy SRM Institute of Science and Technology, Kattankulathur, Chengalpattu

Kancheepuram
TAMIL NADU
603203
India 
Phone  7449277556  
Fax    
Email  jagadeem1@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Arunshankar P 
Designation  Student 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Pharmacy Practice, SRM College of Pharmacy, SRMIST, Potheri, SRM Nagar Kattankulathur, Chengalpattu

Chennai
TAMIL NADU
603203
India 
Phone  7397353836  
Fax    
Email  p.arunshankar818@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology 
 
Primary Sponsor  
Name  SRM Insitute of Science and Technology 
Address  Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203 
Type of Sponsor  Research institution and hospital 
 
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 
Arunshankar P  SRM Medical College Hospital and Research Centre   Department of General Medicine, Room no.4 Diabetic Clinic, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203
Kancheepuram
TAMIL NADU 
7397353836

p.arunshankar818@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre SMR Nagar Potheri Kattankulathur  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  Empagliflozin   25mg tablet orally given once daily for a duration of 3 months 
Comparator Agent  Standard treatment for type 2 diabetes mellitus.  standard treatment prescribed for the patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Estimated glomerular filtration rate 45 to 90 ml per minute .
Diabetic patients HbA1C greater than 6.5 percent
Patients with haemoglobin less than 13.0 g per dL in males.
Haemoglobin less than 12.0 g per dL in females.
 
 
ExclusionCriteria 
Details  End Stage Renal Disease patients Stage 4
Patients with hereditary iron metabolism disorders.
Patients with Type 1 Diabetes mellitus.
Patients with pre-existing Urinary tract or Genital infections and patients who develop this complication during the study.
Patient with pyelonephritis.
Patients already taking diuretics.
Pregnant and Lactating women.
Treatment with any other investigational drug within the previous 30 days of inclusion in the study.
Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
Difficulty in Socio Culture Communication.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Serum erythropoietin, ferritin and transferrin saturation will be assessed at baseline and after 3months.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   11/03/2024 
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="6"
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  

The inclusion of Empagliflozin could be a superior idea in treating patients with both diabetes and CKD in the early stages compared with other counterparts oral hypoglycemic agents like gliptins (DPP-4 inhibitors), owing to its potential ability to stimulate erythropoiesis and prevent the occurrence or progression of anaemia. The considerations that need to be considered while using Empagliflozin are genital infections and urinary tract infections. This has been a well-studied drug for many years and the results of various meta-analysis studies are a testament to the safety of this drug. The drug also prevents the progression of albuminuria and keeps serum creatinine levels in check and is also effective in treating diabetes in early-stage CKD patients. The multidimensional action of this drug in treating diabetes and its associated co-morbidity of anaemia in patients belonging to the described study population strongly indicates that the benefits of including this drug in their treatment could outweigh the risks associated with it. Instead of using antidiabetic drugs and oral iron supplements along with the therapy, using this could reduce the “pill burden” on the patient thus improving medication adherence. The potential of the drug to prevent renal damage and address other major complications associated with CKD as a package justifies why this study could be beneficial, which could give way to a more optimized therapy.

 
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