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CTRI Number  CTRI/2026/01/100048 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 31/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Safe and Effective Are Vildagliptin and Remogliflozin with Metformin in People with Type 2 Diabetes 
Scientific Title of Study   A study of the safety and effectiveness of Vildagliptin and Remogliflozin when added to Metformin in Type 2 Diabetes patients in Kanpur 
Trial Acronym  T2DM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nilam Nigam 
Designation  Professor 
Affiliation  Rama Medical College Hospital and Research Centre, Kanpur 
Address  Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana Kanpur,Uttar Pradesh.
Rama Medical College Hospital and Research Centre, Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India 
Phone  9140190479  
Fax    
Email  drnilamnigam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nilam Nigam 
Designation  Professor 
Affiliation  Rama Medical College Hospital and Research Centre, Kanpur 
Address  Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana Kanpur,Uttar Pradesh.
Rama Medical College Hospital and Research Centre, Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India 
Phone  9140190479  
Fax    
Email  drnilamnigam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Kumar 
Designation  Junior Resident 
Affiliation  Rama Medical College Hospital and Research Centre, Kanpur 
Address  Department of Pharmacology and Therapeutic, 3rd floor, room number 03154, Rama Medical College, Mandhana ,Kanpur , Uttar Pradesh, India
Department of Pharmacology and Therapeutic, 3rd floor, room number 03154, Rama Medical College, Mandhana ,Kanpur , Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
209217
India 
Phone  08303434055  
Fax    
Email  ravikumar17jul@gmail.com  
 
Source of Monetary or Material Support  
Department of Pharmacology and Department of Medicine Infrastructural support by Rama medical college hospital and research centre, madhana Kanpur,uttar pradesh, India-209217 
 
Primary Sponsor  
Name  Rama Medical College Hospital and research centre  
Address  Department of Pharmacology and Therapeutic, 3rd floor, room number 03154, Rama Medical College, Mandhana ,Kanpur , Uttar Pradesh, India -209217 
Type of Sponsor  Private 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 Ravi Kumar  Rama medical college and Hospital  Department of pharmacology room number 03154 and Department of medicine Room Number 1, Rama medical College Hospital and Research Centre, Mandhana Kanpur, Uttar Pradesh, India -209217
Kanpur Nagar
UTTAR PRADESH 
08303434055

ravikumar17jul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Rama medical College Hospital and Research Centre,Kanpur   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  TABLET REMOGLIFLOZIN 100 MG TWICE A DAY PERORAL FOR 3 MONTHS 
Comparator Agent  Vildagliptin  TABLET VILDAGLIPTIN 50 MG TWICE A DAY PERORAL FOR 3 MONTHS 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age between 35 and 70 years all sexes
2.Diagnosed with T2DM with HbA1c more than 6.5 percentage
3.Currently taking a stable dose of metformin (more than equal to 1500 mg per day or maximum tolerated dose) for
more than equal to months.
 
 
ExclusionCriteria 
Details  Use of other anti-diabetic medications besides metformin

Hepatic dysfunction (ALT and AST more than equal to 2.5 UNL or Bilirubin more than 2x UNL)

Renal dysfunction (eGFR less than 45 ml per min per 1.73 m²)

Active genitourinary tract infections and lower limb cellulitis or ulcers

Known case of osteoporosis

Known allergy to study medications

Pregnant or nursing patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Detailed medical history
Systemic examination
blood sugar profile
others biochemical examination

 
Baseline Visit (Day 0) and Follow-up Visit (Day 90):  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   20/01/2026 
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="1"
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  

Background and Rationale Type 2 Diabetes Mellitus is a progressive chronic disease requiring treatment intensification over time to maintain glycemic control

While Metformin is the established Firstline therapy its efficacy diminishes as insulin resistance and beta cell dysfunction worsen

This necessitates add on therapies 

The American Diabetes Association recommends several classes of drugs, including Dipeptidyl Peptidase 4 inhibitors and Sodium-Glucose Cotransporter2 inhibitors, for second line treatment.

        Vildagliptin a DPP4 inhibitor is a well established weight neutral agent with a good safety profile

       Remogliflozin etabonate is a newer SGLT2 inhibitor that not only improves glycemic control but also offers the additional benefits of weight loss and blood   pressure reduction

       Its availability at a lower cost in India makes it a potentially attractive and cost-effective option for a large patient population

 

While both drug classes are effective there is a lack of direct head to head comparative data between the established DPP4 inhibitor Vildagliptin and the newer more affordable SGLT2 inhibitor Remogliflozin especially within the Indian population

 This study aims to address this gap by directly comparing their efficacy and safety as add on therapy in patients with T2DM inadequately controlled with metformin

 

Objectives 

Primary Objective To compare the efficacy of vildagliptin and remogliflozin as add on therapy to metformin in patients with type 2 diabetes mellitus in terms of their effect on HbA1c levels

 

Secondary Objectives To compare the safety of vildagliptin and remogliflozin as add on therapy to metformin

 To compare the effect of vildagliptin and remogliflozin on lipid profile and body weight


 
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