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CTRI Number  CTRI/2016/05/006917 [Registered on: 10/05/2016] Trial Registered Prospectively
Last Modified On: 29/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes  
Scientific Title of Study   Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes - A 40-weeks, randomised, multicentre, multinational, active-controlled, parallel groups, openlabel, four-armed trial (Sustain 7).  
Trial Acronym  SUSTAIN 7 
Secondary IDs if Any  
Secondary ID  Identifier 
NN9535-4216 ver 1.0 dated 14 July 2015  Protocol Number 
U1111-1164-8495   UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Anil N Shinde 
Designation  Director – Clinical, Medical, Regulatory Affairs & Quality (CMRQ) 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka 560 006

Bangalore
KARNATAKA
560066
India 
Phone  91-8040303471  
Fax  08041123517  
Email  ansd@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Anil N Shinde 
Designation  Director – Clinical, Medical, Regulatory Affairs & Quality (CMRQ) 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka 560 006

Bangalore
KARNATAKA
560066
India 
Phone  91-8040303471  
Fax  08041123517  
Email  ansd@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk India Private Ltd.  
 
Primary Sponsor  
Name  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Ltd. "Plot No.32, 47 - 50, EPIP Area, Whitefield" Bangalore Karnataka 560 006  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bulgaria
Canada
Croatia
Finland
Germany
Greece
Hong Kong
India
Ireland
Latvia
Lithuania
Portugal
Romania
Slovakia
Spain
United Kingdom
United States of America  
Sites of Study  
No of Sites = 30  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yashdeep Gupta  AIIMS, New Delhi  Department of Endocrinology and Metabolism AIIMS, Ansari Nagar New Delhi 110029 India
New Delhi
DELHI 		 9958615993

yash_deep_gupta@yahoo.co.in 
Dr Harish Kumar   Amrita Institute of Medical Sciences & Research Centre, Ponekkara  Amrita Institute of Medical Sciences & Research Centre, Department of Endocrinology & Diabetes AIMS-Ponekkara.P.O, Kochi Kerala 682041 India
Ernakulam
KERALA 		 0484-2851234
0484-2858471
manojr@aims.amrita.edu 
Dr Sambit das  Apollo Hospital  Apollo Hospital ,Bhubaneswar Plot No-251,Sainik School Road, Unit 15, Bhubaneshwar Orissa 751005 India
Khordha
ORISSA 		 6747150642
6747150642
sambitd2001@yahoo.co.in 
Dr Nihal Thomas  Christian medical College  Dept of endocrinology Diabetes and metabolism Christian medical College Vellore Tamil Nadu 632004 India
Vellore
TAMIL NADU 		 4162282694
4164200854
nihal_thomas@yahoo.com 
Dr Sandeep Julka  Convenient Hospitals Ltd., CHL-Hospitals   Convenient Hospitals Ltd., CHL-Hospitals [A Unit of CHL-Group of Hospitals] Near L. I. G. Square, A. B. Road, Indore Madhya Pradesh 452008 India
Indore
MADHYA PRADESH 		 07316621157
07314245625
sandep_julka@yahoo.com 
Dr Vaishali Chetan Deshmukh  Deenath Mangeshkar Hospital and Research Centre  Deenath Mangeshkar Hospital and Research Centre 6th Floor, C-Wing C6, Erandawane, Pune Maharashtra 411004 India
Pune
MAHARASHTRA 		 020-40151666
020-40151668
docvaishali@yahoo.co.in 
Dr Parminder Singh  DMC&H Ludhiana  3rd floor, dept of Endocrinology, DMC&H, Civil Lines, Tagore Nagar, DMC&H Ludhiana Punjab 141001 India
Ludhiana
PUNJAB 		 0161-2304656
0161-2304656
pam.endo@yahoo.co.in 
Dr Parag Rajnikant Shah  Dr. Jivraj Mehta Smarak Health Foundation and Bakeri Medical Research Centre  Dr. Jivraj Mehta Smarak Health Foundation and Bakeri Medical Research Centre, Ratubhai Adani Arogyadham, Nr. Ayojan Nagar, Ahmedabad Gujarat 380007 India
Ahmadabad
GUJARAT 		 079-26639839
079-26601411
paragendocrine@yahoo.com 
Dr Kongara Srikanth  Endolife Speciality Hospitals Pvt Ltd  Endolife Speciality Hospitals Pvt Ltd, D.No:12-12-94, Old Club Road Kothapet,Guntur Andhra Pradesh 522 001, India
Guntur
ANDHRA PRADESH 		 91863-2252000
91863-6637160
endolife7@gmail.com 
Dr Kiran Pal Singh  Fortis Hospital  Fortis Hospital, sector 62, Phase 8 Mohali Punjab 160062 India
Nawanshahr
PUNJAB 		 0172-4692222
0172-4692219
drkp1292@gmail.com 
Dr Vijay Sheker Reddy   Gandhi Hospital   Department of Endocrinology, 3rd Floor, Gandhi Hospital Musheerabad Secunderabad Telangana 500003 India
Hyderabad
ANDHRA PRADESH 		 040-27504441
040-27504441
drdvsreddyendo@Yahoo.com 
Dr Alapati Lakshmi Lavanya  Global Hospital  6-1-1070/ 1 to 4,Global Hospital, Lakdi-ka-pool, Hyderabad Telangana 500004 India
Hyderabad
ANDHRA PRADESH 		 040-23244444
040-23233166
alapatil2000@yahoo.com 
Dr Ankush Desai  Goa Medical College  Endocrine Unit Department of Medicine Goa Medical College Bambolim Goa 403202 India
North Goa
GOA 		 08322495372

ankush_desai@rediffmail.com 
Dr Neeraj Manikanth  Government Medical College  Department of General Medicine, Government Medical College Kozhikode Kerala 673008 India
Kozhikode
KERALA 		 9447391055

nmanikath@gmail.com 
Dr Satinath Mukhopadhyay  I.P.G.M.E&R HOSPITAL  I.P.G.M.E&R HOSPITAL RONALD ROSS BUILDING,4TH FLOOR,ROOM NO – 9A 244 A.J.C BOSE ROAD Kolkata West Bengal 700020 India
Kolkata
WEST BENGAL 		 033-22234910
033-22236558
satinath.mukhopadhyay@gmail.com 
Dr Shailaja Kale  Inamdar Multispecialty Hospital   Inamdar Multispecialty Hospital Hospital building S.No . 15 Fatima Nagar Pune, Maharashtra 411040 India
Pune
MAHARASHTRA 		 020-66812222

drshailaja@yahoo.com 
Dr MA Shekar  K. R. Hospital, Mysore Medical College and Research Institute  Department of Endocrinology K. R. Hospital, Mysore Medical College and Research Institute, Irwin Road, Mysore Karnataka 570001 India
Mysore
KARNATAKA 		 9845120106

drsheki@gmail.com 
Dr Thushanth Thomas   Kerala institute Of Medical Sciences  Kerala institute Of Medical Sciences Anayara P O Trivandrum Kerala 695029 India
Thiruvananthapuram
KERALA 		 04713041000
04712446460
drthushanth.thomas@kimsglobal.com 
Dr KAV Subrahamanyam  King George Hospital  Department of Endocrinology, Superspecialty Block, King George Hospital, Maharanipeta, Vishakapatnam Andhra Pradesh 530002 India
Visakhapatnam
ANDHRA PRADESH 		 08912508275
08912508275
kavsendo@yahoo.co.in 
Dr Anupam Prakash  Lady Hardinge Medical College  Room No. 1014, First Floor, Department of Medicine Old Building, Lady Hardinge Medical College, Shahid Bhagat Singh Marg New Delhi New Delhi 110001 India
New Delhi
DELHI 		 9868329333

prakashanupam@hotmail.com 
Dr Nivedita Devabrata Moulick  Lokmanya Tilak Municipal Medical College & General Hospital  Room no 3, First Floor, Department of Medicine, College Building,Lokmanya Tilak Municipal Medical College & General Hospital, Sion (W) Mumbai Maharashtra 400022 India
Mumbai
MAHARASHTRA 		 022-24063079
022-24074624
ndmoulick@rediffmail.com 
Dr I Ranjit Unnikrishnan  Madras Diabetes Research Foundation  Madras Diabetes Research Foundation #4, Conran Smith Road, Gopalapuram, Chennai - 600086 Tamil Nadu India
Chennai
TAMIL NADU 		 04443968888
4428350935
drranjit@drmohans.com 
Dr Dinesh Agarwal  MARWARI HOSPITAL AND RESEARCH CENTRE  ROOM NO. 3, 1ST FLOOR, MARWARI HOSPITAL AND RESEARCH CENTRE S.J.ROAD, ATHGAON,Guwahati Assam 781008 India
Kamrup
ASSAM 		 0361-2602738
0361-2512563
DRDINESH944@GMAIL.COM 
Dr Sandeep Garg  Maulana Azad Medical College  Room No. 120 Department of Medicine B L Taneja Block Maulana Azad Medical College New Delhi New Delhi 110002 India
New Delhi
DELHI 		 011-2323-5452
011-2323-5452
drsandeepgargmamc@gmail.com 
Dr Rakesh Kumar Sahay  Osmania General Hospital  Department of Endocrinology, OP Building, 2nd floor, Osmania General Hospital, Afzalgunj Hyderabad Telangana 500012 India
Hyderabad
ANDHRA PRADESH 		 9849597507

sahayrk@gmail.com 
Dr Sudip Chatterjee  Park Clinic  Park Clinic, 4 Gorky Terrace, On AJC Bose Road, Between Carmac St. & Minto Park Kolkata West Bengal 700017 India
Kolkata
WEST BENGAL 		 3322808424
3322801807
drsudip.chatterjee@gmail.com 
Dr Anil Bhansali  Post Graduate Institute of Medical Education and Research  Sector 12, Near Punjab University, Chandigarh Punjab 160012 India
Chandigarh
CHANDIGARH 		 9478111956

anilbhansali_endocrine@rediffmail.com 
Dr Mala Dharmalingam  Ramaiah Medical College and Hospitals   M S Ramaiah Medical College and Hospitals New BEL Road,MSRIT Post Bangalore Karnataka 560054 India
Bangalore
KARNATAKA 		 08040523022
080-23601983
drmaladharamalingam@gmail.com 
Dr Premlatha Krishnamoorthy Varthakavi  TNM College & BYL nair Ch. Hospital  Department of Endocrinology, TNM College & BYL nair Ch. Hospital Dr A.L.B Nair road, Mumbai Central Mumbai Maharashtra 400008 India
Mumbai
MAHARASHTRA 		 9224480560

premavar@hotmail.com 
Dr K R Raveendra  Victoria Hospital  Room # 72/A, 2nd Floor, C Block Victoria Hospital, Bangalore Medical College and Research Institute, Fort Bangalore Karnataka 560002 India
Bangalore
KARNATAKA 		 9448134587

drkrraveendra@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 30  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, Dayanand Medical College and hospitals  Approved 
Ethics committe, marwari hospital  Approved 
Ethics Committee M S Ramaiah Medical College and Hospitals   Approved 
Ethics committee Apollo Hospitals  Approved 
Ethics Committee for Human Research, Lady Hardinge Medical College  Approved 
Ethics Committee Inamdar Multispeciality Hospital  Approved 
Ethics Committee of Bangalore Medical College and Research Institute  Approved 
Goa Medical College- Institutional Ethics Committee  Approved 
Institutional Ethics Committee, Fortis Hospital  Approved 
Institutional Ethics Committee King George Hospital  Approved 
Institutional ethics committee , Endolife Speciality Hospitals Pvt Ltd  Approved 
Institutional Ethics Committee of Madras Diabetes Research Foundation  Approved 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
Institutional Ethics Committee, AIIMS, New Delhi  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences & Research Centre.  Approved 
Institutional Ethics Committee, Govt Medical College, Kozhikode  Approved 
Institutional Ethics Committee, Kerala institute Of Medical Sciences  Approved 
Institutional Ethics Committee, Post Graduate institute of Medical Education and Research (PGIMER)  Not Applicable 
Institutional Ethics Committee, TNM College & BYL nair Ch. Hospital  Approved 
Institutional Ethics Committee- Deenath Mangeshkar Hospital & Research Centre  Approved 
Institutional Ethics Committee- Global Hospitals  Approved 
Institutional Ethics Committee- Human Research- Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC)  Not Applicable 
Institutional Ethics Committee- Mysore Medical College and Research Institute and Assocaited Hospitals  Not Applicable 
Institutional Human Ethics Committee, Kerala institute Of Medical Sciences  Approved 
Institutional Review Board, Christian Medical college  Approved 
Integrity Ethics committee, Convenient Hospitals Ltd  Approved 
IPGME&R Research Oversight Committee  Approved 
Osmania Medical College Ethics Committee  Approved 
Park Clinic Ethics Committee  Approved 
The JMSHF and BMRC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dulaglutide   0.75 mg or 1.5 mg once weekly s.c. Injection  
Intervention  Semaglutide   0.5 mg or 1.0 mg once weekly s.c. Injection  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  "1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial
2. Male or female, age ≥ 18 years at the time of signing informed consent
3. Subjects with T2D diagnosed clinically ≥ 90 days prior to screening
4. HbA1c 7.0 – 10.5% (53 – 91 mmol/mol) (both inclusive)
5. Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal
tolerated dose documented in the patient medical record) for 90 days prior to screening"
 
 
ExclusionCriteria 
Details  1. Known or suspected hypersensitivity to trial product(s) or related products
2. Previous participation in this trial. Participation is defined as signed informed consent
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
4. Receipt of any investigational medicinal product within 90 days before screening
5. Any condition, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol
6. Treatment with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria in a period of 90 days before screening. An exception is short-term insulin
treatment for acute illness for a total of ≤14 days
7. History of pancreatitis (acute or chronic)
8. Screening calcitonin ≥50 ng/L
9. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid
Carcinoma
10. Renal impairment defined as eGFR 60 mL/min/1.73 m2 as per CKD-EPI
11. Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina
and/or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening
12. Subjects presently classified as being in New York Heart Association (NYHA) Class IV
13. Planned coronary, carotid or peripheral artery revascularisation on the day of screening
14. Proliferative retinopathy or maculopathy requiring acute treatment
15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous
cell skin cancer and in-situ carcinomas)
16. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days
or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid
hormones, corticosteroids)"
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HbA1c
 		 40 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in body weight   40 weeks
 
 
Target Sample Size   Total Sample Size="1196"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "1104"
Final Enrollment numbers achieved (India)="117" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/05/2016 
Date of Study Completion (India) 19/05/2017 
Date of First Enrollment (Global)  06/01/2016 
Date of Study Completion (Global) 19/05/2017 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The trial is a 40-week randomised, open-label, active-controlled, parallel group, multicentre, multinational, four-armed trial. Subjects with type 2 diabetes inadequately controlled with metformin alone will after approximately 2 weeks screening period be randomised in a 1:1:1:1 manner to receive either a dose of 0.5 mg or 1.0 mg of semaglutide once-weekly or 0.75 mg or 1.5 mg of dulaglutide once-weekly. After the treatment period of approximately 40 weeks in total, all subjects enter a follow-up period of 5 weeks ended by a follow-up phone contact. Total trial duration for the individual subjects will be approximately 47 weeks. The aim for the present trial is to compare semaglutide once-weekly versus dulaglutide onceweekly as addition to metformin in a population of subjects with T2D in terms of glycaemic control, weight control and other efficacy parameters. Furthermore, the trial is designed to address and compare tolerability, patient well-being and treatment satisfaction.
 
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