REF/2015/10/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Sun, 26 v :46:26 GMT) CTRI Number Last Modified On 10/05/2016 Post Graduate Thesis Type of Trial Type of Study Study Design CTRI/2016/05/ [Registered on: 10/05/2016] - Trial Registered Prospectively Interventional Drug 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). Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) NN ver 1.0 dated 14 July 2015 U Name Designation Affiliation Address Protocol Number UTN Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Name Designation Affiliation Address Details Contact Person (Scientific Query) Dr MV Srishyla Phone Fax Name Designation Affiliation Address Director, Clnical, Medical, Regulatory and Quality. vo rdisk Private Ltd. vo rdisk Private Ltd. Plot.32, 47-50, EPIP Area, Whitefield Bangalore Karnataka Bangalore KARNATAKA mvsr@novonordisk.com Details Contact Person (Public Query) Avik Kumar Ghosh Head, Clinical Operations vo rdisk Private Ltd. Ltd. Plot.32, 47-50, EPIP Area, Whitefield Bangalore Karnataka Bangalore KARNATAKA page 1 / 10

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > vo rdisk Private Ltd. Name Address Type of Sponsor Name NIL List of Countries Bulgaria Canada Croatia Finland Germany Greece Hong Kong Ireland Latvia Lithuania Portugal Romania Slovakia Spain United Kingdom United States of America Name of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details vo rdisk Private Ltd vo rdisk Private Ltd. "Plot.32, 47-50, EPIP Area, Whitefield" Bangalore Karnataka Pharmaceutical industry-global Address NIL Name of Site Site Address Phone/Fax/ Dr Yashdeep Gupta AIIMS, New Delhi Department of Endocrinology and Metabolism AIIMS, Ansari Nagar New Delhi oo.co.in New Delhi DELHI 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 Ernakulam KERALA u Dr Sambit das Apollo Apollo page 2 / 10

3 Dr Nihal Thomas Dr Sandeep Julka Dr Vaishali Chetan Deshmukh Christian medical Convenient s Ltd., CHL-s Deenath Mangeshkar and Research Centre,Bhubaneswar Plot -251,Sainik School Road, Unit 15, Bhubaneshwar Orissa Khordha ORISSA Dept of endocrinology Diabetes and metabolism Christian medical Vellore Tamil Nadu Vellore TAMIL NADU sambitd2001@yahoo.c o.in nihal_thomas@yahoo.c om Convenient s Ltd., CHL-s [A Unit of CHL-Group of sandep_julka@yahoo.c s] Near L. I. G. om Square, A. B. Road, Indore Madhya Pradesh Indore MADHYA PRADESH Deenath Mangeshkar and Research Centre 6th Floor, C-Wing C6, Erandawane, Pune Maharashtra Pune MAHARASHTRA Dr Parminder Singh DMC&H Ludhiana 3rd floor, dept of Endocrinology, DMC&H, Civil Lines, Tagore Nagar, DMC&H Ludhiana Punjab Ludhiana PUNJAB Dr Parag Rajnikant Shah Dr Kongara Srikanth Dr. Jivraj Mehta Smarak Health Foundation and Bakeri Medical Research Centre Endolife Speciality s Pvt Ltd Dr. Jivraj Mehta Smarak Health Foundation and Bakeri Medical Research Centre, Ratubhai Adani Arogyadham, Nr. Ayojan Nagar, Ahmedabad Gujarat Ahmadabad GUJARAT Endolife Speciality s Pvt Ltd, D.: , Old Club Road Kothapet,Guntur Andhra Pradesh , Guntur docvaishali@yahoo.co.i n pam.endo@yahoo.co.in paragendocrine@yahoo.com endolife7@gmail.com page 3 / 10

4 ANDHRA PRADESH Dr Kiran Pal Singh Fortis Fortis, sector 62, Phase 8 Mohali Punjab Nawanshahr PUNJAB Dr Vijay Sheker Reddy Gandhi Department of Endocrinology, 3rd Floor, Gandhi Musheerabad Secunderabad Telangana Hyderabad ANDHRA PRADESH Dr Alapati Lakshmi Lavanya Global / 1 to 4,Global, Lakdi-ka-pool, Hyderabad Telangana Hyderabad ANDHRA PRADESH drkp1292@gmail.com drdvsreddyendo@yaho o.com alapatil2000@yahoo.co m Dr Ankush Desai Goa Medical Endocrine Unit Department of Medicine Goa Medical Bambolim Goa rth Goa GOA ankush_desai@rediffm ail.com Dr Neeraj Manikanth Dr Satinath Mukhopadhyay Dr Shailaja Kale Dr MA Shekar Government Medical I.P.G.M.E&R HOSPITAL Inamdar Multispecialty K. R., Mysore Medical and Research Institute Department of General Medicine, Government Medical Kozhikode Kerala Kozhikode KERALA I.P.G.M.E&R HOSPITAL RONALD ROSS BUILDING,4TH FLOOR,ROOM NO 9A 244 A.J.C BOSE ROAD Kolkata West Bengal Kolkata WEST BENGAL Inamdar Multispecialty building S.. 15 Fatima Nagar Pune, Maharashtra Pune MAHARASHTRA nmanikath@gmail.com drshailaja@yahoo.com Department of Endocrinology K. R., Mysore drsheki@gmail.com Medical and Research Institute, Irwin Road, Mysore Karnataka page 4 / 10

5 Dr Thushanth Thomas Dr KAV Subrahamanyam Dr Anupam Prakash Dr Nivedita Devabrata Moulick Kerala institute Of Medical Sciences King George Lady Hardinge Medical Lokmanya Tilak Municipal Medical & General Dr I Ranjit Unnikrishnan Madras Diabetes Research Foundation Dr Dinesh Agarwal Dr Sandeep Garg MARWARI HOSPITAL AND RESEARCH CENTRE Maulana Azad Medical Mysore KARNATAKA Kerala institute Of Medical Sciences Anayara P O Trivandrum Kerala Thiruvananthapuram KERALA Department of Endocrinology, Superspecialty Block, King George, Maharanipeta, Vishakapatnam Andhra Pradesh Visakhapatnam ANDHRA PRADESH drthushanth.thomas@ki msglobal.com kavsendo@yahoo.co.in Room. 1014, First Floor, Department of Medicine Old Building, prakashanupam@hotm Lady Hardinge Medical ail.com, Shahid Bhagat Singh Marg New Delhi New Delhi New Delhi DELHI Room no 3, First Floor, Department of Medicine, Building,Lokmanya Tilak Municipal Medical & General, Sion (W) Mumbai Maharashtra Mumbai MAHARASHTRA ndmoulick@rediffmail.c om Madras Diabetes Research Foundation #4, Conran Smith drranjit@drmohans.com Road, Gopalapuram, Chennai Tamil Nadu Chennai TAMIL NADU ROOM NO. 3, 1ST FLOOR, MARWARI HOSPITAL AND RESEARCH CENTRE S.J.ROAD, ATHGAON,Guwahati Assam Kamrup ASSAM DRDINESH944@GMAI L.COM Room Department of Medicine B L Taneja Block drsandeepgargmamc@ Maulana Azad Medical gmail.com page 5 / 10

6 Details of Ethics Committee Dr Rakesh Kumar Sahay Osmania General New Delhi New Delhi New Delhi DELHI Department of Endocrinology, OP Building, 2nd floor, Osmania General, Afzalgunj Hyderabad Telangana Hyderabad ANDHRA PRADESH Dr Sudip Chatterjee Park Clinic Park Clinic, 4 Gorky Terrace, On AJC Bose Road, Between Carmac drsudip.chatterjee@gm St. & Minto Park ail.com Kolkata West Bengal Kolkata WEST BENGAL Dr Anil Bhansali Dr Mala Dharmalingam Dr Premlatha Krishnamoorthy Varthakavi Post Graduate Institute of Medical Education and Research Ramaiah Medical and s TNM & BYL nair Ch. Sector 12, Near Punjab University, Chandigarh Punjab Chandigarh CHANDIGARH M S Ramaiah Medical and s New BEL Road,MSRIT drmaladharamalingam Post Karnataka Bangalore KARNATAKA Department of Endocrinology, TNM & BYL nair Ch. Dr A.L.B Nair road, Mumbai Central Mumbai Maharashtra Mumbai MAHARASHTRA Dr K R Raveendra Victoria Room # 72/A, 2nd Floor, C Block Victoria, Bangalore Medical and Research Institute, Fort Bangalore Karnataka Bangalore KARNATAKA premavar@hotmail.com drkrraveendra@gmail.c om Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Drug Trial Ethics Committee, Dayanand Medical and hospitals Approved 02/03/2016 ECRC-HEC Date Specified page 6 / 10

7 Ethics Committee M S Ramaiah Medical and s Ethics committee Apollo s Ethics Committee for Human Research, Lady Hardinge Medical Ethics Committee Inamdar Multispeciality Ethics Committee of Bangalore Medical and Research Institute Goa Medical - Committee Committee, Fortis Committee King George Institutional ethics committee, Endolife Speciality s Pvt Ltd Committee of Madras Diabetes Research Foundation Committee, Maulana Azad Medical Approved 13/01/2016 Approved 08/03/2016 Approved 13/01/2016 Approved 05/12/2015 Date Specified Date Specified Date Specified Approved 22/01/2016 Approved 17/12/2015 Approved 23/11/2015 Committee, AIIMS, New Delhi Committee, Amrita Institute of Medical Sciences & Research Centre. Committee, Govt Medical, Kozhikode Committee, Kerala institute Of Medical Sciences Committee, Post Graduate institute of Medical Education and Date Specified Date Specified Date Specified Approved 28/01/2016 Date Specified Date Specified page 7 / 10

8 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Research (PGIMER) Committee, TNM & BYL nair Ch. Committee- Deenath Mangeshkar & Research Centre Committee- Global s Committee- Human Research- Lokmanya Tilak Municipal Medical (IEC-HR-LTMMC) Committee- Mysore Medical and Research Institute and Assocaited s Institutional Human Ethics Committee, Kerala institute Of Medical Sciences Institutional Board, Christian Medical college Integrity Ethics committee, Convenient s Ltd IPGME&R Research Oversight Committee Osmania Medical Ethics Committee Park Clinic Ethics Committee The JMSHF and BMRC Committee Status Approved 01/04/2016 Date Specified Approved 09/01/2016 Date Specified Date Specified Approved 31/12/2015 Approved 15/02/2016 Approved 17/12/2015 Date Specified Date Specified Approved 10/12/2015 Approved 18/01/2016 Date Approved/Obtained 09/05/2016 Health Type Patients Condition Type 2 Diabetes Mellitus Type Name Details Intervention Semaglutide 0.5 mg or 1.0 mg once weekly s.c. Injection Comparator Agent Dulaglutide 0.75 mg or 1.5 mg once weekly s.c. Injection Age From Year(s) Inclusion Criteria page 8 / 10

9 Age To Gender Details Year(s) Both "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 % (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" Exclusion Criteria Details Exclusion Criteria 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 page 9 / 10

10 Powered by TCPDF ( REF/2015/10/ hormones, corticosteroids)" Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints Change in HbA1c 40 weeks Secondary Outcome Outcome Timepoints Change in body weight 40 weeks Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Total Sample Size=1196 Sample Size from =130 11/05/ /01/2016 Years=1 Months=5 Days=0 Open to Recruitment t Yet Recruiting t yet. Brief Summary The trial is a 40-week randomised, open-label, active-controlled, parallel group, multicentre, multinational, fouralone will after approximately 2 weeks screening period be randomised in a 1:1:1:1 manner to receive either a dulaglutide once-weekly. After the treatment period of approximately 40 weeks in total, all subjects enter a follo the individual subjects will be approximately 47 weeks. The aim for the present trial is to compare semaglutide population of subjects with T2D in terms of glycaemic control, weight control and other efficacy parameters. Fu well-being and treatment satisfaction. page 10 / 10