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CTRI Number  CTRI/2023/03/050384 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 26/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the effect of Remogliflozin 100 mg or Dapagliflozin 10 mg adding to standard of care treatment for Type II Diabetes patients having chronic kidney disease  
Scientific Title of Study   A Prospective, multicenter, randomized, non-inferior study to evaluate the effect of Remogliflozin 100 mg vs Dapagliflozin 10 mg in addition to standard of care, in patients of Type 2 Diabetes Mellitus (T2DM) with Chronic Kidney Disease (REMO- CKD) 
Trial Acronym  Remo-CKD 
Secondary IDs if Any  
Secondary ID  Identifier 
IIS/2022/03 version 1.0 16 Jan 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Hemant Gupta  
Designation  Physician 
Affiliation  Grant Govt. Medical college and Sir JJ. Group of Hospitals 
Address  Grant Govt. Medical college and Sir JJ. Group of Hospitals, Byculla, Mumbai-400008 MAHARASHTRA

Mumbai
MAHARASHTRA
400008
India 
Phone  9870456888  
Fax    
Email  drhemantgupta@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Hemant Gupta  
Designation  Physician 
Affiliation  Grant Govt. Medical college and Sir JJ. Group of Hospitals 
Address  Grant Govt. Medical college and Sir JJ. Group of Hospitals, Byculla, Mumbai-400008 MAHARASHTRA

Mumbai
MAHARASHTRA
400008
India 
Phone  9870456888  
Fax    
Email  drhemantgupta@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Hemant Gupta  
Designation  Physician 
Affiliation  Grant Govt. Medical college and Sir JJ. Group of Hospitals 
Address  Grant Govt. Medical college and Sir JJ. Group of Hospitals, Byculla, Mumbai-400008 MAHARASHTRA

Mumbai
MAHARASHTRA
400008
India 
Phone  9870456888  
Fax    
Email  drhemantgupta@hotmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Glenmark Pharmaceuticals Limited Glenmark House, HDO Corporate Bldg. A Wing,B.D.Sawant Marg, Off W.E.Highway,Chakala, Andheri (E), Mumbai-400099  
 
Primary Sponsor  
Name  Prof Dr Hemant Gupta 
Address  Grant Govt. Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai 400008 MAHARASHTRA 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chaitanya Sawant  Priyadarshani Nursing Home  OPD 1-3, Dept. of Nephrology, Priyadarshani Nursing Home, M-Baria Estate, Kargil nagar Road, Opp. Manvel Pada, Talav, Virar (East) Dist. Palghar - 401305
Mumbai (Suburban)
MAHARASHTRA 		 8106969477

drchaitanyaswant11@gmail.com 
Dr Aashay Pandya   Shivam Hospital   C-4, Satya Narayan Society, Jashodananagr Chaar Rasta, Mani Nagar (E), Ahmedabad-380008, Gujarat, India
Ahmadabad
GUJARAT 		 7383930812

ashay.pandya@gmail.com 
ProfDr Hemant Gupta  Sir J.J. Group of hospitals   OPD No 20, Department of Medicine, OPD Building, Grant Govt. Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai 400008. Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9870456888

drhemantgupta@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IEC-NHCNH  Approved 
IEC-NHCNH  Approved 
Shivam Ethics Committee  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 
Comparator Agent  Dapagliflozin 10 mg  one tablet once daily for 24 weeks 
Intervention  Remogliflozin Etabonate (RE), 100 mg  one tablet twice daily for 24 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Adults (more than or equal to 18 years) of either gender diagnosed with Type-2 Diabetes Mellitus more than 6 months back
2) Having uncontrolled glycaemia (HbA1c more than 7.0 percent & Less than 9.0 percent) with no change in anti-diabetic treatment therapy since last 8 weeks
3) On stable therapy (more than 6weeks prior to screening) of metformin monotherapy or dual therapy of metformin plus other OHA
4) Patients who are on following concomitant background medications for CKD management: ACEi and ARB if not medically contraindicated -With comorbid chronic kidney disease diagnosed at least 3 months prior to screening
5) Patients with eGFR more than or equal to 25 ml per min per 1.73m2 to Less than or equal to 60 ml per min per 1.73m2 at time of initiation of treatment
6) Evidence of increased albuminuria 3 months or more and UACR more than or equal to 200 and less than or equal to 5000 mg per g at visit 1
7) Patients requiring treatment with SGLT2i for T2DM management as part of routine clinical practice
8) Patients who understand & willing to comply with study requirements and provide written informed consent for participation
 
 
ExclusionCriteria 
Details  1) Female patients who are pregnant or breast feeding
2) Patients with known liver or kidney dysfunction (eGFR less than 25 ml per min per 1.73m2) at time of initiation of treatment.
3) Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
4) Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
5) History of organ transplantation
6) Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
7) New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
8) MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Change in renal parameters (eGFR, Sr Creatinine, BUN and uric acid) at 12 weeks and 24 weeks as compared to baseline.
• Change in UACR at 12 weeks and 24 weeks as compared to baseline.
 		 12 weeks & 24 Weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in FPG, PPG and HBA1C
 		 at 12 weeks and 24 weeks compared to baseline 
Change in Body Weight  at 24 weeks compared to baseline 
Patients achieving HBA1C level less than 7%   Week 24 
Incidence of adverse event and SAEs
Tretament emergent Adverse event and TSAEs 		 Baseline to week 24 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   11/03/2023 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a prospective, multicentre, randomized, open-label, active controlled study to evaluate the effect of Remogliflozin 100 mg vs Dapagliflozin 10 mg in addition to standard of care, in patients of Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease (CKD).

The study would be initiated at each site after review and approval from ethics committee (IRB/IEC). The patients of T2DM with CKD would be screened and written informed consent would be obtained before undertaking any study related procedures. On day of screening (visit 1, Day -7 to 0), basic demographic & clinical characteristics, including age, gender, duration of T2DM, CKD, NYHA and background treatment would be acquired. The physical examination, blood and other laboratory investigations as per Schedule of assessments would be done.

The patients would be followed up for next visit for randomization (visit 2, Day 1). On day of randomization (visit 2, Day 1), full eligibility as per the selection criteria would be ascertained and the eligible patients would be randomized to either of treatment groups (Remogliflozin 100 mg or Dapagliflozin 10 mg) as per randomization plan. At the baseline/randomization visit, further detailed medical history along with changes in medications from screening will be obtained. Within the appropriate range of the therapeutic goal, the participant’s background treatment will be, in principle and if possible, unchanged during the trial interval for at least 6 months for CKD (Chronic Kidney Disease) & anti-diabetic medication. Post-randomization follow-up visits are scheduled at 12 weeks (visit 3) and 24 weeks (visit 4).

The Body Mass Index (BMI), Body weight (BW), waist circumference, vitals & physical examination and details of concomitant medications would be recorded at screening, baseline (visit 2), visit 3 and visit 4. Laboratory assessment of Hemogram, Renal function parameters namely eGFR, UACR, Sr Creatinine, Sr BUN, Sr Uric acid, FPG, PPG, HbA1c would be performed at screening, visit 3 and visit 4.

The safety would be assessed by continuous monitoring of treatment emergent adverse events (including AEs of special interest such as hypoglycemic events, urinary tract infection, genital fungal infection, and excess osmotic diuresis signs), safety laboratory values and vital signs.

Treatment and study duration is of 24 weeks. 
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