| 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
|
|
|
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
|
|
|
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. |