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CTRI Number  CTRI/2026/01/101066 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Common Diabetes Medicine Combinations to See Which Controls Blood Sugar Better in Type 2 Diabetes Patients 
Scientific Title of Study   To Compare the Efficacy of Vildagliptin-Metformin Versus Dapagliflozin-Metformin in Achieving Glycemic Control Among Patients with Type 2 Diabetes Mellitus 
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 Shubhseerat Kaur 
Designation  Junior Resident 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143501 
Address  VPO Chhajjalwadi Tehsil Baba Bakala Amritsar,143149

Amritsar
PUNJAB
143149
India 
Phone  9872872601  
Fax    
Email  kaurshubhseerat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avtar Singh Dhanju  
Designation  Professor  
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143001  
Address  306 Greenfield Avenue, Majitha Road Amritsar Punjab 143001 India

Amritsar
PUNJAB
143001
India 
Phone  7009067238  
Fax    
Email  AVTAR.DHANJU.AD@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  Dr Shubhseerat Kaur  
Designation  Junior Resident  
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143501  
Address  VPO Chhajjalwadi Tehsil Baba Bakala Amritsar,143149

Amritsar
PUNJAB
143149
India 
Phone  9872872601  
Fax    
Email  Kaurshubhseerat@gmail.com  
 
Source of Monetary or Material Support  
Department of Medicine Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143501  
 
Primary Sponsor  
Name  Department of Medicine  
Address  Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143501  
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 AVTAR SINGH DHANJU   DEPARTMENT OF MEDICINE  Sri Guru Ram Das Institute of Medical Sciences and Research AMRITSAR
Amritsar
PUNJAB 		 7009067238

AVTAR.DHANJU.AD@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Group A Vildagliptin + Metformin Vildagliptin 50 mg Metformin in standard dose Frequency: As per standard prescription Duration: 12 weeks  
Comparator Agent  Group B  Group B Dapagliflozin + Metformin Dapagliflozin 10 mg Metformin in standard dose Frequency: As per standard prescription Duration: 12 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults above 30 years of age.


2. Patients with HbA1c greater than 7%.


3. Patients who are newly diagnosed (treatment-naive) OR inadequately controlled on Metformin monotherapy.


4. Patients willing to participate and provide written informed consent. 
 
ExclusionCriteria 
Details  1. Type 1 Diabetes Mellitus or Gestational Diabetes.


2. Severe renal impairment (eGFR less than 45 mL/min/1.73 m²) or significant hepatic dysfunction.


3. Patients currently on insulin or other OHAs (except prior Metformin).


4. Known contraindication to Vildagliptin, Dapagliflozin, or Metformin. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the change in HbA1c from baseline to 12 weeks between patients receiving vildagliptin–metformin and dapagliflozin–metformin  Baseline
6 weeks follow-up
12 weeks follow-up
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   25/01/2026 
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   This prospective randomized comparative study will evaluate the efficacy and safety of two antidiabetic drug combinations—vildagliptin-metformin versus dapagliflozin-metformin—in adult patients with Type 2 Diabetes Mellitus inadequately controlled on metformin monotherapy or treatment-naive. A total of 100 participants will be randomized into two equal groups. Glycemic parameters (FBS, PPBS, HbA1c), body weight, blood pressure, and adverse events will be assessed at baseline, 6 weeks, and 12 weeks. The study aims to generate comparative evidence to guide optimal combination therapy in Type 2 Diabetes Mellitus. 
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