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CTRI Number  CTRI/2024/09/073221 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Phase 3 study will assess the efficacy, safety, and tolerability of a fixed-dose combination (FDC) of dapagliflozin 10mg and pioglitazone 15mg tablets versus separate doses of Forxiga 10mg and Pioglit® 15mg in Type 2 diabetes patients inadequately controlled on metformin monotherapy. 
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 and Pioglitazone Tablets 10mg/15mg of USV Private Limited., India as compared to Concomitant Administration of Reference Product Forxiga 10 mg (Dapagliflozin) of AstraZeneca Pharma India limited., along with Pioglit® 15 mg (Pioglitazone) tablets of Sun Pharma Laboratories India Ltd., in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin containing mono therapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SB-IND-CT-043 Version 1.0, dated 31 Mar 2022  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 Shridhar S B 
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

Mumbai
MAHARASHTRA
400088
India 
Phone  9739180005   
Fax    
Email  sridhar.sb@usv.in  
 
Details of Contact Person
Public Query  
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

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  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Keshao B Nagpure  All India Institute of Medical Sciences Hospital   Plot No 2 Sector 20 Mihan Nagpur 441108 MH India
Nagpur
MAHARASHTRA 		 9822086848

kartikmed@rediffmail.com 
Dr Ritesh Agarwal  AMRI Hospital  Plot No 1 Near jaydev vatika park Khandagiri Bhubaneswar Khordha Odisha 751019
Khordha
ORISSA 		 9861336985

drritesh.agrawal@amribbsr.in 
Dr Chinmoy Barik  College of Medicine and JNM Hospital  College of Medicine and JNM Hospital, Kalyani. Nadia, West Bengal- 741235
Nadia
WEST BENGAL 		 9830290854

chinmoybk@gmail.com 
Dr Asif Qureshi  Cresent Hospital and Heart Center  Near lokmat square near dhantoli Nagpur 440012
Nagpur
MAHARASHTRA 		 9226151571

drmaq@rediffmail.com 
Dr Ajaykumar Ajmani   Dr B L Kapur Memorial Hospital  Pusa road New Delhi 110005 India
New Delhi
DELHI 		 9818270890

drajaykajmani@blkhospital.com 
Dr Manjunath Goroshi  Goroshi Clinic  1st Floor, Forum Builders, SP Office Road, Belgaum, 590010
Belgaum
KARNATAKA 		 9930270424

manjunath.r.goroshi@gmail.com 
Dr Jigar Modia  Jupiter Hospital  Ataldara sun pharma road Vadodara 390012
Vadodara
GUJARAT 		 9913041639

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

drambrishmedstar@gmail.com 
Dr Shrikanth Metri  Metri Clinic  Second floor block no 30 Gandhi Bhawan Behind Sanman Hotel Belgavi Karnataka
Belgaum
KARNATAKA 		 9986539415

shrikanthmetri@gmail.com 
Dr Mohan Magdum  Poona Hospital and Research Centre  Poona Hospital and Research Centre, 27, L B Shastri Road, Sadashiv Peth, Near Alka Theatre, Pune, India 411030
Pune
MAHARASHTRA 		 9822217243

mohanmagdum@gmail.com 
Dr Pravin Chavan  Premier Hospital  House No. 778, In front of Amrut Siddhi hall, Trimurti Colony, Kalamba, Kolhapur 416007
Kolhapur
MAHARASHTRA 		 8087045046

pravinchavan.crd@rediffmail.com 
Dr Prabhat Kumar Agrawal  SN Medical College  Raja mandi near Agra college agra Central Library, Moti Katra, Mantola, Agra, Uttar Pradesh 282003
Agra
UTTAR PRADESH 		 9319250485

ppagrawal120@gmail.com 
Dr Praveenkumar Devarbhavi  Subbaiah Institute Of Medical Sciences  NH-13 , HH Road , Purale Shivamoga, Karnataka 577222
Shimoga
KARNATAKA 		 9986108182

devarbhavi.endocrine@gmail.com 
Dr Mukulesh Gupta  Udyaan Healthcare Hospital  730, Udyan 1 Eldeco, Opp. AWHO, Near Bangla Bazar, Lucknow – 226002
Lucknow
UTTAR PRADESH 		 8401325512

drmukulesh@yahoo.com 
Dr Kapil Borawake  Vishwaraj Hospital  Solapur Highway, Loni Kalbhor Road, Loni Railway Station, kadamvakvasti, Pune - 412201
Pune
MAHARASHTRA 		 9765634036

drkapilb@gmail.com 
Dr Namdev Jagtap  Vishwaraj Hospital  Gate no 499, kadamvakvasti, solapur road, loni kalbhor, Pune, Maharashtra, 4122001, India
Pune
MAHARASHTRA 		 8007874541

drjagtapdev@gmail.com 
Dr Adarshkumar Bellad  Vishwaratna Hospital  Near Kolhapur circle, SP office road, Ayodhya nagar, Belgaum 590016
Belgaum
KARNATAKA 		 9483946447

adarshbellad@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee of Poona Hospital and Research Centre  Submittted/Under Review 
Ethics Committee of Subabaiah Institute of Medical Science  Approved 
IEC College of Medicine and JNM Hospital  Approved 
Independent Ethics Committee of Zest Ethics LLP  Approved 
Independent Ethics Committee of Zest Ethics LLP   Approved 
Institutional Ethics Committee of MAEERS Vishwaraj Hospital   Approved 
Institutional Ethics Committee S N Medical College  Approved 
Medstar Speciality Hospital Ethics Committee  Approved 
Om Sai Onco Institutional Ethics Committee  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 
Comparator Agent  Fixed Dose Combination of Dapagliflozin + Pioglitazon Tablets   Fixed Dose Combination of Dapagliflozin + Pioglitazon Tablets 10mg/15mg USV Private Limited., India in Patients with Type 2 Diabetes Mellitus and Patients will be advised to take one tablet orally once a day, swallowed as a whole with water in the morning after meal around same time every day for 12 Weeks 
Intervention  Forxiga 10mg tablets (Dapagliflozin) and Pioglit 15 mg tablets (Piolglitazone Hydrochloride)   Concomitant Administration of Reference Products, Forxiga® 10mg tablets (Dapagliflozin) of AstraZeneca Pharma India limited., and Pioglit® 15 mg tablets (Piolglitazone Hydrochloride) of Sun Pharma Laboratories India Ltd., India in Patients with Type 2 Diabetes Mellitus and Patients will be advised to take one tablet orally once a day, swallowed as a whole with water in the morning after meal around same time every day for 12 Weeks  
 
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.
2. Patients who have ongoing mono therapy - to be enrolled and continue them with dual therapy. i.e Patients with HbA1C level ≥ 7.5% to 10%.and who are presently on ≥1000 mg/day Metformin for at least 3 months prior to screening
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 7.5% at the 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) 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3 
Date of First Enrollment (India)   18/09/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study

 

Test Product: Fixed Dose Combination of Dapagliflozin and pioglitazone Tablets 10mg/15mg of USV Private Limited., India administered in morning (OD).

 Reference Products: Concomitant administration of Forxiga 10   mg (Dapagliflozin) tablets of AstraZeneca Pharma India limited  and Pioglit®    15 mg (Pioglitazone) tablets, of Sunpharma Laboratories Pharmaceuticals, administered in morning (OD).
  
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