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CTRI Number  CTRI/2022/09/045148 [Registered on: 01/09/2022] Trial Registered Prospectively
Last Modified On: 10/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to assess the efficacy and safety of combination of Vildagliptin plus Pioglitazone Tablets in patients with diabetes. 
Scientific Title of Study   “A Phase III, Prospective, Randomized, Double Blind, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Vildagliptin SR 100 mg plus Pioglitazone 15 mg Tablets Versus FDC of Teneligliptin 20 mg plus Pioglitazone 15 mg Tablets in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRPL/CT/20/004, Version No.: 01 and Dated Apr 11, 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajasekhara Reddy Tamma 
Designation  Managing Director 
Affiliation  Clinwave Research Pvt. Ltd. 
Address  Clinwave Research Pvt. Ltd., Plot No.: 38, Kamala Prasanna Nagar, Near Ramalayam Temple, Kukatpally.

Hyderabad
TELANGANA
500072
India 
Phone  7989233379  
Fax    
Email  dr.sekhar@clinwave.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajasekhara Reddy Tamma 
Designation  Managing Director 
Affiliation  Clinwave Research Pvt. Ltd. 
Address  Clinwave Research Pvt. Ltd., Plot No.: 38, Kamala Prasanna Nagar, Near Ramalayam Temple, Kukatpally.

Hyderabad
TELANGANA
500072
India 
Phone  7989233379  
Fax    
Email  dr.sekhar@clinwave.co.in  
 
Details of Contact Person
Public Query
 
Name  Mr Surender Kumar Arora 
Designation  President - Drug Regulatory Affairs 
Affiliation  Synokem Pharmaceuticals Ltd. 
Address  Synokem Pharmaceuticals Ltd., 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi.

New Delhi
DELHI
110087
India 
Phone  9811015684  
Fax    
Email  ska@synokempharma.com  
 
Source of Monetary or Material Support  
Synokem Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  Synokem Pharmaceuticals Ltd 
Address  14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. 
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 Chintan B Patel  Aatman Hospital  Clinical Research Room, 5, Anveshan Row House, Bopal Gam BRTS, Bopal-Ghuma Road, Bopal, Ahmedabad-380058.
Ahmadabad
GUJARAT 
9825182251

cr.aatman@gmail.com 
Dr Arindam Naskar  Calcutta School of Tropical Medicine  Department of Endocrinology, Government of West Bengal, 108, Chittranjan Avenue, Calcutta-700073.
Kolkata
WEST BENGAL 
9874749626

dr.arindam83@gmail.com 
Dr Jilla Naganna  Gandhi Medical College and Hospital  In Patient Block, 3rd Floor, Department of General Medicine, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA 
9666345120

nagan99@gmail.com 
Dr Lalit Kumar  GSVM Medical College  Post Graduate Department of Medicine, LLR Hospital, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH 
9889264230

lalit85gsvm@gmail.com 
Dr Sanjiv Maheshwari  Jawahar Lal Nehru (J.L.N) Medical College  Department of Medicine, KalaBagh, Ajmer-305001.
Ajmer
RAJASTHAN 
9460479888

doctor.sanjiv@gmail.com 
Dr Prabhat Kumar Sharma  Maharaja Agrasen Superspeciality Hospital  Room No. 109, Basement, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN 
9983995050

pksharma.clinical@gmail.com 
Dr Raja Bhattacharya  Medical College and Hospital, Kolkata  Department of Medicine, MCH Building, 4th Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL 
9477305539

rbrbhattacharya@gmail.com 
Dr Vijaykumar Bhagwan Barge  Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital  Department of Medicine, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002.
Kolhapur
MAHARASHTRA 
8080328480

rcsmgmc.research@gmail.com 
Dr Sagar Vivek Redkar  Redkar Hospital and Research Centre  Research Room, Mumbai-Goa Highway, Oshalbag, Village-Dhargal, Tal-Pernem, Goa-403513.
North Goa
GOA 
9158592177

redkar.research@gmail.com 
Dr Mohan Kumar Singh  W Pratiksha Hospital  Research Room, Basement-2, Golf Course Ext. Road, Sushant Lok II, Sector 56, Gurugram-122011.
Gurgaon
HARYANA 
9910431665

drmksingh2012@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, Calcutta School of Tropical Medicine  Approved 
Ethics Committee, GSVM Medical College  Approved 
Institutional Ethics Committee for Human Research, Medical College and Hospital  Approved 
Institutional Ethics Committee, Aatman Hospital  Approved 
Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital  Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital  Approved 
North East Healthcare Private Limited, W Pratiksha Hospital  Approved 
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)  Approved 
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre  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  FDC of Teneligliptin 20 mg plus Pioglitazone 15 mg Tablets  Patients will be advised to take one tablet orally, swallowed as a whole with water in the morning after breakfast around same time every day for 16 weeks. 
Intervention  FDC of Vildagliptin SR 100 mg plus Pioglitazone 15 mg Tablets  Patients will be advised to take one tablet orally, swallowed as a whole with water in the morning after breakfast around same time every day for 16 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 received stable dose of Metformin ≥ 1500 mg/day as monotherapy for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥ 8.0% to ≤ 11.0%.
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. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
3. Patients with a history of bariatric surgery or lap-band procedure within 12 months prior to screening.
4. Patients with Fasting Plasma Glucose (FPG) > 270 mg/dL at screening (If FPG is > 270 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 270 mg/dL, patient will be excluded from the study).
5. Patients with the Body Mass Index (BMI) ≥ 45.0 kg/m2 at screening.
6. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
7. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
8. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
9. 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.
10. Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
11. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
12. Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes.
13. Patients who are accepting treatments of arrhythmias.
14. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
15. Patients with known history of acute pancreatitis.
16. Patients with a history of treatment with estrogens and other medications known to affect bone.
17. Patients with history of clinically significant peripheral edema in past 6 months.
18. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other DPP4 inhibitors or thiazolidinediones.
19. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
20. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
21. Patients with history of any malignancy.
22. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
23. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
24. 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.
25. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
26. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
27. Suspected inability or unwillingness to comply with the study procedures.
28. 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   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (16 weeks).  At Screening / baseline visit,
Visit 5 (Week 12 / Day 84±2) and
Visit 6 (Week 16 / Day 112±2). 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (16 weeks).  At Screening / baseline visit,
Visit 3 (Week 2 / Day 14±2)
Visit 4 (Week 6 / Day 42±2)
Visit 5 (Week 12 / Day 84±2) and
Visit 6 (Week 16 / Day 112±2). 
Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (16 weeks).  At Screening / baseline visit,
Visit 3 (Week 2 / Day 14±2)
Visit 4 (Week 6 / Day 42±2)
Visit 5 (Week 12 / Day 84±2) and
Visit 6 (Week 16 / Day 112±2). 
Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (16 weeks).  At Visit 6 (Week 16 / Day 112±2). 
Mean change in body weight from baseline to end of the study visit (16 weeks).  At Screening / baseline visit,
Visit 3 (Week 2 / Day 14±2)
Visit 4 (Week 6 / Day 42±2)
Visit 5 (Week 12 / Day 84±2) and
Visit 6 (Week 16 / Day 112±2). 
Hypoglycemic episodes during the study  During the treatment period.
From Visit 2 (Day 1) to Visit 6 (Day 112)
Visit 3 (Week 2 / Day 14±2)
Visit 4 (Week 6 / Day 42±2)
Visit 5 (Week 12 / Day 84±2) and
Visit 6 (Week 16 / Day 112±2). 
Adverse events / serious adverse events reported during the
study. 
During the treatment period.
From Visit 2 (Day 1) to Visit 6 (Day 112)
Visit 3 (Week 2 / Day 14±2)
Visit 4 (Week 6 / Day 42±2)
Visit 5 (Week 12 / Day 84±2) and
Visit 6 (Week 16 / Day 112±2). 
Changes in clinical laboratory parameters from baseline to end of the study visit (16 weeks).  At Screening / baseline visit and
Visit 6 (Week 16 / Day 112±2). 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/09/2022 
Date of Study Completion (India) 23/03/2023 
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  

This trial is a phase III, prospective, randomized, double blind, comparative, parallel group, multicenter clinical study to evaluate the efficacy, safety and tolerability of FDC of Vildagliptin SR 100 mg + Pioglitazone 15 mg Tablets versus FDC of Teneligliptin 20 mg + Pioglitazone 15 mg Tablets in patients with type 2 diabetes mellitus inadequately controlled on Metformin monotherapy.

 

Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged between 18 to 65 years (both inclusive), who are on the treatment with Metformin Tablets ≥1500 mg/day for at least 3 months prior to screening and having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of ≥ 8.0% to ≤ 11.0%] will be considered for the study.

 

After confirming the inclusion/exclusion criteria the subject will be randomized and provided with study medication at randomization visit. Subjects will be provided with diary at randomization visit, which need to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on week 2/day 14(±3), week 6/day 42(±3), week 12/day 84(±3) and week 16/day 112(±3) (Final Visit) of treatment to assess efficacy, safety and tolerability.

 

Patients will be assigned to either of the two arms i.e., Arm A or Arm B consisting of FDC of Vildagliptin SR 100 mg + Pioglitazone 15 mg Tablets or FDC of Teneligliptin 20 mg + Pioglitazone 15 mg Tablets. Patients will be given the study medication once daily for 16 weeks. In addition, subjects will continue to receive Metformin at stable doses of ≥1500 mg/day, throughout the study period in an open label manner (16 weeks).

 
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