PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 18:25:59 GMT) CTRI Number CTRI/2014/09/005033 [Registered on: 18/09/2014] - Trial Registered Prospectively Last Modified On 27/11/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A trial to evaluate the Efficacy and safety of semaglutide given once weekly versus insulin glargine given once daily as add on to metformin with or without sulphonylurea in subjects with type 2 diabetes ,who have not yet been treated with insulin. Scientific Title of Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to Study metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes Secondary IDs if Any Secondary ID Identifier 2013-004392-12 ClinicalTrials.gov NN9535 3625ver 2.0 dated 05 Feb 2014 Protocol Number U1111-1146-0211 UTN Details of Principal Details of Principal Investigator Investigator or overall Name Trial Coordinator (multi-center study) Designation Affiliation Address Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Raman Shetty Query) Designation Director Affiliation Novo Nordisk India Private Ltd Address Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore KARNATAKA 560 066 India Phone 918040303200 Fax 918041119026 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Mr Avik Kumar Gosh Designation Head-Clinical Operations Affiliation Novo Nordisk India Private Ltd Address Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore KARNATAKA India Bangalore KARNATAKA 560 066 India page 1 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 918040303200 Fax 918041119026 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Novo Nordisk AS Primary Sponsor Primary Sponsor Details Name Novo Nordisk AS Address c/o Novo Nordisk India Private Ltd Plot No.32, 47 - 50,EPIP Area, Whitefield, Bangalore - 560 066 India Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor NA NA Countries of List of Countries Recruitment Argentina Croatia France Germany India Mexico Netherlands Romania Slovakia Slovenia South Africa The former Yugoslav Republic of Macedonia United Kingdom United States of America Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr M Ashraf Ganie All India Institute of Department of 01126593237 Medical Sciences Endocrinology and 01126589162 Metabolism, Room [email protected] no.310, 3rd Floor m Biotechnology Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi DELHI DrPremlata B.Y.L. Nair Hospital and Department of 9224480560 Krishnamoorthy T.N.Medical College, Endocrinology College 02223080601 Varthakavi Building, 4th Floor, [email protected] Room No. 19, Dr. A. L. Nair Road, Mumbai MAHARASHTRA Dr Sreenivasamurthy L Cauvery Medical 1st floor,Cinical 9448051046 Centre Hospital research room,Cauvery Medical Centre [email protected] Hospital,#43/2, Bellary road, NH.7,Sahakara page 2 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Nagar, Bengaluru - 560092 Bangalore KARNATAKA Dr GM Prasad Columbia Asia Hospital Clinical Research 08041791000 - Hebbal, Room,Department of 08041791002 endocrinology,Kirloskar [email protected] Business Park, Bellary m Road, Bangalore KARNATAKA Dr Parag Shah Dr. Jivraj Mehta Health Ground 9723150524 Foundation floor,Ayojannagar, Ahm edabad,Gujarat,380007 paragendocrine@yahoo Ahmadabad .com GUJARAT Dr Kalyan Kumar Fortis Hospital, 4rth floor,Research 03366284444 Gangopadhyay Room,730 03366284242 Anandapur,Fortis [email protected] Hospital, Kolkata WEST BENGAL Dr Nalini Samir Shah Global Hospitals Deparment of 02267670101 Superspeciality and Endocrinology, 912267670181 Transplant center, Diabetes and [email protected] Metabolism, 35, Dr. E. Borges Road, Hospital Avenue, Opp. Shirodkar High School, Parel, Mumbai MAHARASHTRA Tiven Marwah HCG Multi Speciality 5th floor,Mithakhali, 00919824055857 Hospital Ellisbridge, Ahmadabad [email protected] GUJARAT m Dr Basavana JSS Hospital, Research room,Dept of 08212548363 Gowdappa H clinical pharmacy, JSS 08212548368 Hospital, MG Road, [email protected] Mysore Mysore KARNATAKA Dr M A Shekar Krishna Rajendra Ground floor,Endocrine 9845120106 Hospital (K R Hospital), dept,Tertiary Referral 08212420142 Center and Teaching [email protected] Hospital attached to the Mysore Medical College, Mysore Medical College and Research Institute, Irwin Road, Mysore KARNATAKA Dr Anupam Prakash Lady Hardinge Medical room no:1014;1st 01123363728 College and Smt. floor,Department of 1123343984 Sucheta Kriplani Medicine, Lady prakashanupam@hotm Hospital, Hardinge Medical ail.com College & Smt. Sucheta Kriplani Hospital, Shahid Bhagat Singh page 3 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Marg, New Delhi DELHI Dr ND Moulick Lokmanya Tilak Room Number- 03, 02224063076 Municipal Medical First Floor, College 02224074624 College and General Building Department of [email protected] Hospital, Medicine, Lokmanya om Tilak Municipal Medical College and General Hospital, Sion Mumbai MAHARASHTRA Dr Sivagnanam Prashanth Hospital, ground floor,research 04442277777 Nallaperumal room,Prashanth 04428366770 Hospital,77, Harrington swamydiabetes@gmail. Road, Chetpet, com Chennai 600031, Chennai TAMIL NADU Dr Shehla Sajid Shaikh Prince Aly Khan Aminabad Building, 4th 02223777800 Akhtar Hospital, Floor, Flat no. 25, 02223743820 Prince Aly Khan [email protected] Hospital, Aga Hall, m Nesbit Road, Mazagaon, Mumbai MAHARASHTRA Dr Debasish Maji Vivekananda Institute of 1st floor,Research 03324753636 Medical Sciences, Room,Near Emergency 03324754351 Block,Ramakrishna [email protected] Mission Seva Pratishthan, 99, Sarat Bose Road Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? "Ethics Committee Submittted/Under No Date Specified No Mysore Medical College Review & Research Institute and Associated Hospitals.Dr. M A Shekar Cuavery Medical Approved 26/07/2014 No Centre Institutional Ethics Committee,Bang alore,Dr Sreenivasamurthy Ethics Committee for Approved 04/07/2014 No Human Research, Lady Hardinge Medical College and Associated Hospitals, Shahid Bhagat Singh Marg, New Delhi-110001.Dr. Anupam Prakash Ethics Committee, Submittted/Under No Date Specified No Global hospital, Room Review page 4 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in no 214, Dr. E. Borges Road, Hospital Avenue, Opposite Shirodkar High high School, Parel, Mumbai - 400012, Maharashtra.Dr Nalini Shah Ethics Committee, Approved 05/09/2014 No Prashanth Hospital, 77, Harrington Road, Chetpet, Chennai 600031, Tamil Nadu ;Dr Nallaperumal Fortis Hospital Ethics Approved 05/09/2014 No Committee, 730 Anandapur, Kolkata - 700107, West Bengal;Dr Kalyan Kumar Gangopadhyay HCG Multispeciality Approved 26/07/2014 No Ethics Committee,Ahm edabad,Dr Tiven Marwah Insitutional Ethics Submittted/Under No Date Specified No Committee Columbia Review Asia Hospitals, Columbia Asia Referral hospital, Yeshwanthpur, 26/4, Brigade Gateway, Beside Metro, Malleswaram West, Bangalore 560055. Dr G M Prasad Institutional Ethics Submittted/Under No Date Specified No Comittee,Topiwala Review National medical College and BYL Nair Charitable HospitalMumbai,Dr premalatha Varthakavi Institutional Ethics Approved 09/08/2014 No Committe,Jivarag Mehta Smarak Health FoundationDr Parag Shah Institutional Ethics Submittted/Under No Date Specified No Committee Lokmanya Review Tilak Municipal Medical College 2nd Floor , Room No. 17 Sion Mumbai- 400022, Maharashtra.Dr. ND Moulick Institutional Ethics Approved 20/06/2014 No Committee, JSS Medical College & Hospital, 3rd Floor, JSS Medical College, page 5 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Mysore 570004, Karnataka;Dr. Hathur Basavana Gowdappa Institutional Ethics Approved 11/08/2014 No Committee, Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99 Sarat Bose Road, Kolkata 700026, West Bengal.Dr. Debasish Maji Institutional Ethics Submittted/Under No Date Specified No Committee, Room 102, Review 1st Floor, Old O.T. block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029. Dr Ashraf Ganie Prince Aly Khan Approved 25/06/2014 No Hospital, Institutional Ethics Committee, Aga Hall, Nesbit Road, Mazagaon, Mumbai- 400 010, Maharashtra,Dr Shaikh Shehla Sajid Akhtar Regulatory Clearance Status Date Status from DCGI Approved/Obtained 16/09/2014 Health Condition / Health Type Condition Problems Studied Patients Diabetes Type 2 Patients Type 2 diabetes mellitus Intervention / Type Name Details Comparator Agent Intervention Semaglutide 0.5mg/week Injected Subcutaneously;once weekly;following 4 dosesof 0.25 mgsemaglutide weeklysubjects will receive0.5 mg semaglutide weekly for 26 weeks Intervention Semaglutide 1.0mg/week Injected Subcutaneously;once weekly;following 4 dosesof 0.25 mg semaglutide weekly and 4 dosesof 0.5 mg semaglutide subjects will receive 1.0 mg semaglutide weekly for 22 weeks Comparator Agent Insulin Glargine Injected Subcutaneously once daily.Subjects will start with 10IU once daily and the dose will be adjusted according to the fasting plasma glucose-duration 30 weeks Inclusion Criteria