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CTRI Number  CTRI/2022/10/046453 [Registered on: 13/10/2022] Trial Registered Prospectively
Last Modified On: 19/10/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Post Marketing Observational Study to Assess Safety and suitability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients 
Scientific Title of Study   A Multicentric Active Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
VILD-521-0190 4.0 dated 27-July-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Bhadada  
Designation  Professor and Head 
Affiliation  PGIMER 
Address  Nehru Extension Block,Ground Floor,Room number 004 Madhya Marg,Sector12, Chandigarh,160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9876602448  
Fax    
Email  bhadadask@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Ashwini Pawar 
Designation  Director Medical Affairs 
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E), Mumbai, MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
4000051
India 
Phone  8454041733  
Fax    
Email  ashwini.pawar@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director Clinical Development & Operation 
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E), Mumbai, MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
4000051
India 
Phone  8657552543  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Private Limited 
 
Primary Sponsor  
Name  Abbott Healthcare Pvt Ltd 
Address  Floor 16, Godrej BKC, Plot No. C-68, BKC, NearMCA Club, Bandra (E), Mumbai – 400051." 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asirvatham A J  Arthur Asirvatham Hospital  Ground Floor 42-a, Kuruvikaran Salai, Anna bus Stand, Madurai-625020, Tamil Nadu
Madurai
TAMIL NADU 		 9443751977

drajasirvatham@yahoo.co.in 
Dr Anirban Majumdar  Diabetes-Obesity-Thyroid and Hormone clinic  Ground Floor, room no.26A, Gariahat Road (South), Dhakuria, Kolkata,-700031 India.
Kolkata
WEST BENGAL 		 9830078837

dranirbanmazumdar@gmail.com 
Dr Govardhan Rao  Excel Hospital  1st floor 1-5-56-29, Old Alwal RD, Beside Bharat petroleum, Near IG statue, Banda Basti, Old Alwal, Alwal, Secunderabad, Telangana-500010
Hyderabad
TELANGANA 		 7731030321

doctorresearch1212@gmail.com 
Dr Surabhi Jindal  Jindal Super Speciality Hospital  1st Floor Mathura bypass Road, SPM Nagar,U.I.T. Colony, Bharatpur-321001, Rajasthan.
Bharatpur
RAJASTHAN 		 7703816673

surjindal@yahoo.co.uk 
Dr Sandeep Gaidhani  Life Care Hospital  New Nashik,Mumbai,Agra Highway,Lekha Nagar Nashik-422009,Maharastra
Nashik
MAHARASHTRA 		 7588606598

drsandeepgaidhani@gmail.com 
Dr Pravin Nagulal Soni  PCMCs PGI Yashwantrao Chavan Memorial Hospital  2nd Floor, General Medicine Department, Sant Tukaram Nagar, Pimpri-411018, Pune
Pune
MAHARASHTRA 		 9822057511

drpravinsoni18@gmail.com 
Dr Sanjay Badada  PGIMER, Dept. of Endocrinology  Nehru Extension Block, Ground Floor, Room number 004 Madhya Marg, Sector 12, Chandigarh, 160012 India.
Chandigarh
CHANDIGARH 		 9876602448

bhadadask@rediffmail.com 
Dr Ashutosh Sonawane  Sarthak Health Clinic  Shop no. 5 to 8, 1st floor, Tajane Anusaya complex, Above SBI insurance, Mumbai Naka, Nashik-422001, Maharashtra
Nashik
MAHARASHTRA 		 9637768831

ashumarch@gmail.com 
Dr Vishal Gupta  SMS Medical college and attached Hospital  Dr. Vishal Gupta, 2nd Floor, Room no 2F, SMS Medical college and attached Hospital, J.N.N Marg Jaipur, Rajesthan-302004, India
Jaipur
RAJASTHAN 		 8107769802

drvishalguptamd@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee, SMS Medical College and attached Hospital  Approved 
Excel Hospital Institutional Ethics Committee  Approved 
Institutional Ethics Committee, Arthur Asirvatham Hospital  Approved 
Jindal Superspeciality Hospital Institutional Ethics Committee  Approved 
Muktai Hospital Institutional Ethics Committee  Approved 
Navsanjeevani Hospital Ethics Committee  Submittted/Under Review 
OrciVita Independent Ethics Committee  Approved 
Postgraduate Institute of Medical Education and Research , Chandigarh Institutional Ethics Committee  Approved 
Yashwantrao Chavan Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Vildagliptin  Tab. Vildagliptin 100 mg SR Formulation once daily for 24 weeks(168 days) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The inclusion criteria are in accordance with the approved prescribing information and the subjects meeting all of the criteria will be included:
1.Male and female patients above 18 years of age.
2.Type 2 diabetes mellitus patients prescribed Vildagliptin 100mg SR once daily formulation by the treating physician as per the approved prescribing information and in accordance with the clinical practice.
3.Patients willing to sign patient authorization form (PAF) 
 
ExclusionCriteria 
Details  The exclusion criteria are in accordance with the approved prescribing information and
the subjects meeting any of the criteria will be excluded:
1. Known case of type 1 Diabetes Mellitus (DM)
2. Known history of any acute metabolic diabetic complications such as ketoacidosis
3. Patients with known history of heart failure NYHA functional class IV
4. Patients with known history of hepatic impairment including patients with a pretreatment ALT or AST >2.5X the upper limit of normal
5. Patients with known history of moderate or severe renal impairment or End Stage
Renal Disease (ESRD)
6. Patient with known hypersensitivity to Vildagliptin or to any of the excipients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24  Baseline to week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Change in HbA1c, FPG, LFT (AST and ALT), Serum Creatinine, Serum Amylase, Serum Lipase from baseline to week 24.  Baseline to week 24 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   24/10/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A Multicentric Active Post Marketing Surveillance Study to
Evaluate the Safety and Tolerability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients conducted on approximately on 210 patients from approximately 14 clinical sites. There are three visits in the study and study duration is of 168 days (24 weeks)+/- 2 week window period. 
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