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CTRI Number  CTRI/2022/07/044440 [Registered on: 28/07/2022] Trial Registered Prospectively
Last Modified On: 15/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Phase III Randomized Open Label Parallel Multicentric clinical study 
Scientific Title of Study   A Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination of Dapagliflozin + Vildagliptin and Metformin Tablets (5/50/500)mg USV Private Limited, as compared to Reference Products, concomitant administration of Forxiga® (Dapagliflozin Tablets 5mg) + GlycoMet® Metformin 500 mg and Fixed dose combination of Galvus-Met® (Vildagliptin 50mgMetformin HCl 500mg) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin dual therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SB-IND-CT-006 Amendment 1.0 Dated 10 Dec 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sridhar SB 
Designation  Head Clinical Research 
Affiliation  USV Pvt Ltd 
Address  USV Pvt Ltd Clinical Research Department Arvind Vithal Gandhi Chowk BSD marg Station Road Gowandi East Mumbai Maharashtra 400088 India

Mumbai
MAHARASHTRA
400088
India 
Phone  9739180005  
Fax    
Email  sridhar.sb@usv.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Neel Lahoti 
Designation  CEO Synergen Bio 
Affiliation  Synergen Bio Private Limited 
Address  Synergen Bio Private Limited Unit Nos.101 to 104 Sai Chambers 302 Old Mumbai-Pune Highway Wakdewadi Shivajinagar Pune Maharashtra

Pune
MAHARASHTRA
411003
India 
Phone  9028000444   
Fax    
Email  Neel@synergenbio.com  
 
Source of Monetary or Material Support  
USV Pvt Ltd. Arvind Vithal Gandhi Chowk BSD Marg Station Road Govandi East Mumbai-400088 Maharashtra India 
 
Primary Sponsor  
Name  USV Pvt Ltd  
Address  Govandi East Mumbai 400088 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karishma Manwani   Amrut Hospital  Amrut hospital A/4, Bhagwati Park, Neartube company, opposite gajanan complex, old padra road, gujarat
Vadodara
GUJARAT 		 9925529932

karishma.manwaninm@gmail.com 
Dr Ashok Shetty  Belgavi Institute of Medical Science   BIMS 3rd Floor Research room BIMS building Dr B R Ambedkar road karnataka 590001
Belgaum
KARNATAKA 		 9448266972

drashokshetty@gmail.com 
Dr Prabhatkumar Agrawal  Care Hospital  27/144, ashok nagar, Panchkuiyan Near Mathur Vaishya Seva Sadan, Agra , UP-282001 India
Agra
UTTAR PRADESH 		 9319250485

ppagrawal120@gmail.com 
Dr Sumankumar Roy  College Of Medicine & JNM Hospital  Department of community medicine College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal 741235
Nadia
WEST BENGAL 		 9433011051

sumanroy1970@gmail.com 
Dr Maulesh Tailor  Divine Multispeciality Hospital  2nd & 3rd floor Shikshapatri sky court Near Swagat Flamingo Sargasan Gandhinagar 382421 Gujarat India
Gandhinagar
GUJARAT 		 9979867922

drmauleshtailor@yahoo.com 
Dr Manjunath Goroshi  Goroshi Clinic  Flat No. 202 Clssic Appartments P Bunglow Near Kolhapur circle road Belgaum
Belgaum
KARNATAKA 		 9930270424

Manjunath.r.goroshi@gmail.com 
Dr Jigar Modia  Jupiter Hospital  9 Suryavilas society Near Gotri Police station Vadodara Gujarat 390021
Vadodara
GUJARAT 		 9913041639

drjigarmodianm@gmail.com 
Dr Ambrish C  Medstar Speciality Hospital  641 17 13 Medstar Speciality Hospital Kodegehalli Main road Sahakarnagar Bangalore 560092 Karnataka India
Bangalore
KARNATAKA 		 9845895911

drambrishmedstar@gmail.com 
Dr Mohan Magdum  Poona Hospital & Research Centre  27 L B Shastri road Near Alka Theatre Sadashiv Peth, Pune 411030
Pune
MAHARASHTRA 		 9822217243

mohanmagdum@hotmail.com 
Dr Praveenkumar Devarbhavi  Subbaiah Institute of Medical Sciences   NH-13 Road Purle Shivamagga, Karnataka 577202
Shimoga
KARNATAKA 		 9986108182

praveen.devarbhavi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Anand Institutional Ethics Committee  Approved 
Care Hospital Ethics Committee  Approved 
Ethiclin Private Limited  Approved 
Ethics Committee Of Poona Hospital & Research Centre  Submittted/Under Review 
Ethics Committee Subbaiah Institute Of Medical Sciences  Approved 
IEC of College Of Medicine & JNM hospital  Approved 
Institutional ethics committee BIMS  Submittted/Under Review 
Medstar Speciality Hospital Ethics Commitee  Approved 
Pagarav Ethics Committee  Approved 
Raneshwar Multispeciality Hospital IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  FDC of Dapagliflozin 5mg Vildagliptin 50 mg and Metformin 500 mg   Morning & Evening for 12 weeks (BID) 
Comparator Agent  Reference 1- Concomitant administration of Forxiga® Tablet containing Dapagliflozin (5mg) of AstraZeneca & Glycomet® Tablet containing Metformin (500mg) of USV Pvt. Ltd Reference 2 – FDC GalvusMet® Tablet containing Vildagliptin (50mg) Metformin (500mg) of Novartis India Ltd.  Morning & Evening for 12 Weeks (BID) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of
Type 2 diabetes mellitus at the time of informed consent.
2. Patients who are presently on Metformin dual therapy (i.e. a combination of Metformin
500mg with Vildagliptin 50 mg or Dapaglifloxin 5 mg BID, for at least 12 weeks prior
to screening and having HbA1c levels of ≥ 7.5 % to ≤ 10% at screening/baseline.
3. Women of childbearing potential (WOCBP) must be using an acceptable method of
contraception to avoid pregnancy throughout the study. WOCBP must have a negative
urine pregnancy test at screening / baseline visit.
4. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
5. Patient with ability to understand and provide written informed consent form, which must
have been obtained prior to screening.
6. Patients willing to comply with the protocol requirements 
 
ExclusionCriteria 
Details  1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or
diabetes insipidus.
2. Subjects with symptomatic urinary tract infection or mycotic genital infection at
screening or history of a recent symptomatic infection within 4 weeks prior to screening
3. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
4. Patients with the Body Mass Index (BMI) ≥ 45.0 kg/m2 at screening
5. Patients with Fasting Plasma Glucose (FPG) > 240 mg/dL at screening or randomization
6. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using
the Modification of Diet in Renal Disease (MDRD) equation] or serum creatinine level
of 1.5 mg/dL for male subjects and 1.4 mg/dL for female subjects at screening.
7. Patients with significant cardiovascular history defined as: myocardial infarction,
unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed
arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts),
or cerebrovascular accident.
8. Intolerance, contraindication or potential allergy/hypersensitivity to any of the
ingredients of study medication or any other SGLT2 or DPP4 inhibitors
9. Subjects with symptomatic urinary tract infection or mycotic genital infection at
screening or history of a recent symptomatic infection within 4 weeks prior to screening
10. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL
for men; haemoglobin < 9 g/dL for women at screening.
11. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the
study.
12. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
13. Patients with a history of substance abuse or dependence that in the opinion of the
Investigator is considered to interfere with the patient’s participation in the study.
14. Patients with concurrent participation in another clinical trial or any investigational
therapy within 90 days prior to signing informed consent.
15. Suspected inability or unwillingness to comply with the study procedures
16. Patient with any condition which, in the judgment of the Investigator, may render the
patient unable to complete the study or which may pose a significant risk to the patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study
visit (12 Weeks) 		 SCREENING / BASELINE VISIT [V1](Day -7) Randomization visit [V2] (Day1) Follow up visit [V3] Week 2 / Day 14(±2) Follow up visit [V4] Week 6 / Day 42(±2) FINAL VISIT [V5]
Week 12/Day 84 (±2)
 
 
Secondary Outcome  
Outcome  TimePoints 
• Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit
(12 Weeks).
• Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of
the study visit (12 Weeks).
• Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (12 Weeks) 		 Follow up visit [V3] Week 2 / Day 14(±2) Follow up visit [V4] Week 6 / Day 42(±2) FINAL VISIT [V5]
Week 12/Day 84 (±2) 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="202" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/08/2022 
Date of Study Completion (India) 14/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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)?  

Response - NO
Brief Summary
Modification(s)  		 It is a  Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study.
Study comprises of 3 Arms .
For this study, test product will  be FDC of Dapagliflozin 5mg + Vildagliptin 50 mg and Metformin 500 mg tablets of USV Pvt. Ltd., administered in morning and evening (BID).
Reference products will be â€¢ Reference 1 - Concomitant administration of Forxiga® Tablet containing Dapagliflozin (5mg) of AstraZeneca + Glycomet® Tablet containing Metformin (500mg) of USV Pvt. Ltd
 â€¢ Reference 2 – FDC GalvusMet® Tablet containing Vildagliptin (50mg) + Metformin (500mg) of Novartis India Ltd (BID).
Total duration of the study is 12 weeks and there will be total 5 Visits.
 
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