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CTRI Number  CTRI/2020/02/023120 [Registered on: 05/02/2020] Trial Registered Prospectively
Last Modified On: 08/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Remogliflozin with vildagliptin in the treatment of diabetes 
Scientific Title of Study   Efficacy and Safety of Vildagliptin and Remogliflozin as add on therapy to Metformin in patients of Type 2 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Chawla 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Dept of Pharmacology Maulana azad medical college delhi

New Delhi
DELHI
110002
India 
Phone    
Fax    
Email  drshalinichawla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhupinder singh 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College 
Address  Dept of Pharmacology Maulana azad medical college delhi
Bahadur shah zafar marg delhi
New Delhi
DELHI
110002
India 
Phone  9810785004  
Fax    
Email  drbskalra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhupinder singh 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College 
Address  Dept of Pharmacology Maulana azad medical college delhi
Bahadur shah zafar marg delhi
New Delhi
DELHI
110002
India 
Phone  9810785004  
Fax    
Email  drbskalra@gmail.com  
 
Source of Monetary or Material Support  
Maulana azad medical college, bahadur shah zafar marg, Delhi 110002 
 
Primary Sponsor  
Name  Maulana azad medical college 
Address  Bahadur shah zafar marg, Delhi 110002 
Type of Sponsor  Government medical college 
 
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 Vikram Sharma  lok Nayak Hospital  Room no. 325,326, Diabetic clinic, OPD block, Lok nayak hospital
Central
DELHI 
8826012309

vikramsharma161@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
maulana azad medical college and associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Remogliflozin  Patients will receive tablet Remogliflozin 100mg twice daily with tablet Metformin 1000-3000mg daily dosage. 
Comparator Agent  Vildagliptin  Will receive tablet Vildagliptin 50mg twice daily with tablet Metformin 1000-3000mg daily dosage. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with age between 35 to 70 years of all sexes.
2.Patients with diagnosis of type 2 diabetes mellitus with uncontrolled glycaemia on taking metformin alone. 
 
ExclusionCriteria 
Details  1.Patients on any other anti-diabetic medications other than metformin.
2. Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase ≥2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL).
3.Patient with renal dysfunction (with estimated glomerular filtration rate [eGFR] as per MDRD formula < 45 ml/min/1.73 m2.
4.Patients with genitourinary tract infections.
5.Patients with lower limb cellulitis, ulcer and amputations.
6.Patients with osteoporosis and bone fractures.
7.Patients with acute pancreatitis.
8.Patients with comorbid serious illness such as tuberculosis, HIV, malignancy.
9.Patients allergic to the study medications.
10. Pregnant female patients and nursing mothers will also be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment.  Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in lipid profile.
2.Change in weight.
3.Frequency of hypoglycemic episodes.
4.Safety profile of both groups. 
Change in from baseline to 12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/02/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes mellitus is one of the most common chronic diseases globally responsible for increased morbidity and mortality. The global prevalence of diabetes among adults is estimated to be 6.4%, affecting 285 million people, in 2010, and is expected to increase to 7.7%, affecting 439 million people by 2030.

The position statement of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) recommends the use of one of six commonly used antihyperglycemic agents i.e. 1) sulfonylurea (SU), 2) thiazolidinedione, 3) dipeptidyl peptidase-4 (DPP4) inhibitor, 4) sodium-glucose cotransporter-2 (SGLT2) inhibitor, 5) glucagon-like peptide-1 (GLP-1) receptor agonist, or 6) basal insulin analogue, as an add-on therapy when the individualized HbA1c target is not achieved after 3 months of treatment with metformin alone.

 Vildagliptin, a potent and selective inhibitor of dipeptidyl peptidase-4 (DPP-4), improves glycemic control by increasing the availability of endogenous incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Remogliflozin, a selective inhibitor of sodium-glucose cotransporter subtype 2 (SGLT2), which is to be administered as Remogliflozin Etabonate, the prodrug for Remogliflozin. Inhibition of SGLT2 (which is selectively expressed in the proximal convoluted tubules of kidney) leads to increased excretion of glucose in urine, resulting in reduced blood glucose concentrations and has therapeutic benefit in T2DM. Remogliflozin is available relatively at lower cost than the existing medications of same class being marketed in india. Remogliflozin thus can prove to be a cost-effective drug in treatment of type 2 diabetes mellitus in developing country like India.

This study is proposed with the hypothesis that remogliflozin may be non-inferior to vildagliptin in the treatment of type 2 diabetes mellitus.

 

 


 
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