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CTRI Number  CTRI/2020/04/024938 [Registered on: 30/04/2020] Trial Registered Prospectively
Last Modified On: 03/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Patients with major Adverse Events With Type 2 Diabetes 
Scientific Title of Study   Protocol I8F-MC-GPGN(a) The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04255433  ClinicalTrials.gov 
Protocol number I8F-MC-GPGN(a) version dated 10/12/2019  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Arora 
Designation  Medical Director  
Affiliation  Eli Lilly and Company (India) Pvt. Ltd.  
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  arora_rohit@lilly.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Arora 
Designation  Medical Director  
Affiliation  Eli Lilly and Company (India) Pvt. Ltd.  
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  arora_rohit@lilly.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava  
Designation  Associate Director  
Affiliation  Eli Lilly and Company (India) Pvt. Ltd.  
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  shrivastava_rajeev_sharan@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001  
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd  
Address  Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Slovakia
Spain
Sweden
Taiwan
Turkey
Ukraine
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ambuj Roy  All India Institute of Medical Sciences (AIIMS)  Ansari Nagar, New Delhi-110029 India
New Delhi
DELHI 		 011-26593861

drambujroy@gmail.com 
Dr Suvro Banerjee  Apollo Gleneagles Hospitals  58, Canal Circular Road, Kolkata – 700054
Kolkata
WEST BENGAL 		 03323203040

drsuvrob@gmail.com 
Dr Paramesh   Bangalore Diabetes Centre  No. 426, 4th Cross, 2nd Block, Kalyan Nagar, Bangalore -560043
Bangalore
KARNATAKA 		 9845010610

Drparamesh2@gmail.com 
Dr Upendra Kaul  Batra Hospital and Medical Research Centre  1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi – 110062
New Delhi
DELHI 		 01129958747

kaul.upendra@gmail.com 
Dr Sandeep Julka  Care CHL-Hospitals  CARE CHL-Hospitals (Unit of Convenient Hospitals Ltd), Near L. I. G. Square, A. B. Road, Indore - 452008, Madhya Pradesh, India
Indore
MADHYA PRADESH 		 9977999687

sandeep_julka@yahoo.com 
Dr Bipin Kumar Sethi  Care Hospital  2-260 /A-E Babu Khan Chambers, Road No 10 Banjara Hills, Hyderabad, Andhra Pradesh-500035
Hyderabad
TELANGANA 		 9440365585

sethibipin54@gmail.com 
Dr Keyur Parikh  CIMS Hospital Pvt. Ltd.  Plot No. 67/1. Opp. Panchamrut Bunglows, Nr. Shukan Mall, Off Science City Road, Sola, Ahmedabad – 380060
Ahmadabad
GUJARAT 		 07930101166

keyur.paikh@cims.me 
Dr Vaishali Deshmukh  Deenanath Mangeshkar Hospital & Research Center  Near, Mhatre Bridge, Erandwane, Pune, Maharashtra-411004
Pune
MAHARASHTRA 		 02040151000

drvaishaliresearch@gmail.com 
Dr Shailesh Pitale  Dew Medicare and Trinity Hospital  Plot No 80 81, Hindustan Colony, Wardha Road, Nagpur-440015, Maharashtra, India
Nagpur
MAHARASHTRA 		 9822225631

drpitale@yahoo.co.in 
Dr Vimal Mehta  G.B. Pant Institute of Postgraduate Medical Education and Research  Jawahar Lal Nehru Marg, New Delhi – 110002
New Delhi
DELHI 		 9718599105

drvimalmehta@yahoo.co.in 
Dr Parag Shah  Gujarat Endocrine Centre  B-201, Silver Brook, Opp. Doctor House, Nr. Parimal Crossing, Ellis bridge, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT 		 07926461316

paragendo@gmail.com 
Dr Tushar Ramkrishna Bandgar  King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College  Acharya Donde Marg, Parel, Mumbai – 400012
Mumbai
MAHARASHTRA 		 02224162917

drtusharb@gmail.com 
Dr Pramod Gandhi  Kingsway Hospital  SPANV Medisearch Lifescience Pvt Ltd, 44, Kingsway Near Kasturchand Park,Nagpur, 440001, Maharashtra, lndia
Nagpur
MAHARASHTRA 		 9823042258

Drpdggandhi1@yahoo.co.in 
Dr V Mohan  Madras Diabetes Research Foundation  4 Conran Smith Road, Gopalapuram, Chennai, Tamil Nadu 600086
Chennai
TAMIL NADU 		 9840097370

drmohans@diabetes.ind.in 
Dr R R Kasliwal  Medanta, The Medicity  Sector – 38, Gurugram - 122001
Gurgaon
HARYANA 		 1244141414

rr.kasliwal@medanta.org 
Dr Ashwani Mehta  Sir Ganga Ram Hospital  Rajinder Nagar, New Delhi-110060
New Delhi
DELHI 		 011-42251547

drashwanimehta@gmail.com 
Dr Nikhil Bhagwat  Topiwala National Medical College & BYL Nair Hospital  Dept. of Endocrinology # 19, 4th floor, College Building, Dr. A. L. Nair Road, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA 		 9820238399

bhagwatnik@yahoo.co.in 
Dr Sunil Thanvi  Zydus Hospitals & Healthcare Research Pvt Ltd  Near Sola Bridge, S.G. Highway, Thaltej Ahmedabad – 380054, Gujarat
Ahmadabad
GUJARAT 		 07966190201

sunilthanvi@zydushospitals.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Ethics Committee of Care Institute of Medical Sciences, Care Institute of Medical sciences  Approved 
Ethics Committee, Kingsway Hospital  Approved 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
Gastroplus Ethics Committee, Gastroplus Hospital  Approved 
Institute Ethics Committee, AIIMS  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee of Madras Diabetes Research Foundation  Approved 
Institutional Ethics Committee, Apollo Gleneagles Hospitals  Approved 
Institutional Ethics Committee, Care Hospital  Approved 
Institutional Ethics Committee, Lata Mangeshkar Medical Foundation’s  Submittted/Under Review 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
Institutional Ethics Committee, Rughwani Child Care Centre and Hospital  Approved 
Institutional Ethics Committee, Seth G. S. Medical College & K. E. M. Hospital  Approved 
Integrity Ethics Committee  Approved 
Medanta Institutional Ethics Committee (MIEC)  Approved 
Medisys Clinisearch Ethical Review Board  Approved 
Scientific Research and Ethical Review Committee  Approved 
Zydus Hospital Ethics Committee Zydus Hospitals & Healthcare Research Pvt Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dulaglutide  Dulaglutide administered SC once a week upto 24 weeks. Dosage should be initiated and maintained at 1.5 mg 
Intervention  Tirzepatide  Tirzepatide administered subcutaneously (SC) once a week upto 24 weeks Starting dosage should be 2.5 mg to be escalated to 15 mg. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Have a diagnosis of type 2 diabetes
2. Have confirmed atherosclerotic cardiovascular disease
3. HbA1c ≥7.0% to ≤10.5%
4. Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) 
 
ExclusionCriteria 
Details  1. Have had a major cardiovascular event within the last 60 days
2. Have type 1 diabetes mellitus
3. Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
4. Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
5. Currently planning a coronary, carotid, or peripheral artery revascularization
6. Have a history of pancreatitis
7. Have a history of ketoacidosis or hyperosmolar state/coma
8. Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
9. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
10. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)  Randomization up to Study Completion (Approximate Maximum 54 Months)  
 
Secondary Outcome  
Outcome  TimePoints 
Time to Death from Any Cause
Time to CV Death
Time to First Occurrence of MI
Time to First Occurrence of Stroke
 		 Randomization up to Study Completion (Approximate Maximum 54 Months) 
Percentage of Participants with More than 10% Weight Loss  36 Months 
Change from Baseline in Body Weight
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Urinary Albumin to Creatinine Ratio
Change from Baseline in Blood Lipids 		 Baseline, End of Study (Approximate Maximum 54 Months) 
Time to First Occurrence of Revascularization
Time to First Occurrence of Hospitalization Due to Unstable Angina
Time to First Occurrence of New or Worsening Nephropathy
Time to CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina  		 Randomization up to Study Completion (Approximate Maximum 54 Months) 
Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke
Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits  		 End of Study (Approximate Maximum 54 Months) 
 
Target Sample Size   Total Sample Size="12500"
Sample Size from India="550" 
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)   29/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="2"
Days="17" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk. 
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