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CTRI Number  CTRI/2018/02/012158 [Registered on: 26/02/2018] Trial Registered Prospectively
Last Modified On: 26/12/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Product Registry 
Study Design  Other 
Public Title of Study   A observational study assessing the real world data on inititating treatment of Toujeo after oral antidiabetic drug failure in insulin-naive patients with Type 2 Diabetes Mellitus patients. 
Scientific Title of Study   A 12–month prospective observational study assessing the real-world clinical effectiveness, safety and health-economic benefits of Toujeo® initiation after oral antidiabetic drug failure in insulin-naïve patients with type 2 diabetes mellitus 
Trial Acronym  ATOS 
Secondary IDs if Any  
Secondary ID  Identifier 
OBS14708  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  DrGodhuli Chatterjee 
Designation  Senior Medical Advisor 
Affiliation  Sanofi India Limited 
Address  Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai– 400072

Mumbai
MAHARASHTRA
400072
India 
Phone  02228032822  
Fax  02228032842  
Email  Godhuli.Chatterjee@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Ekata Shah 
Designation  Clinical Project Leader 
Affiliation  Sanofi India Limite 
Address  Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai

Mumbai
MAHARASHTRA
400072
India 
Phone  02228032175  
Fax  02228032842  
Email  ekata.shah@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi India Limited Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai Mumbai:400072 
 
Primary Sponsor  
Name  Sanofi India Limited 
Address  Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai:400072 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Colombia
Egypt
India
Indonesia
Israel
Jordan
Kazakhstan
Kuwait
Lebanon
Mexico
Peru
Philippines
Qatar
Russian Federation
Singapore
Taiwan
Thailand
Ukraine
United Arab Emirates
Saudi Arabia  
Sites of Study
Modification(s)  
No of Sites = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr HARISH KUMAR  Amrita Institute of Medical Sciences  Dept. of Endocrinology & Diabetes, Amrita Institute of Medical Sciences, Ponekkara P O, Kochi 41, Kerala
Ernakulam
KERALA 		 9895545190

harishkumar@aims.amrita.edu 
Dr Rishi Shukla  Center For Diabetes And Endocrine Disease  C113/14, Shahi Darbar Apartment, Swaroop Nagar, Kanpur - 208002
Kanpur Nagar
UTTAR PRADESH 		 9415042286

drrishishukla@gmail.com 
Dr Anjali Bhatt  Chellaram Diabetes Institute  1st Floor, Lalani Quantum, Bavdhan budruk,Pune 411021
Pune
MAHARASHTRA 		 9552440681

aab@cdi.org.in 
Dr Dakshata Padhye  Conquer Diabetes  12th Floor, 1201, Gold Crest Building, L T Road, Borivali West, Opposite Mannubhai Jewellers, Mumbai - 400092
Mumbai
MAHARASHTRA 		 9820075840

drdakshatapadhye@gmail.com 
Dr Sailesh Lodha  Dear Foundation Clinic  759, Tonk Road, 1st Gopalpura Crossing, Mahavir Nagar, Jaipur, 302018
Jaipur
RAJASTHAN 		 9829019055

saileshlodha@rediffmail.com 
Dr Surendra Kumar Sharma  Diabetes Thyroid Endocine Research & Speciality Centre  A-1, Ajmer Road Sodala (near ESIC hospital) Jaipur, 302006
Jaipur
RAJASTHAN 		 9810071445

sksharma7@gmail.com 
Dr B M Makkar  Dr Makkars Diabetes And Obesity Centre  A-5B/122, Paschim Vihar, New Delhi-110063
New Delhi
DELHI 		 9910047419

drbmmakkar@gmail.com 
Dr Aravinda Jagadeesha  Dr.Aravind’s Diabetes Centre  No. 14 & 15, 3rd Block, 4th Stage, Basaveshwaranagar, Bangalore-560079
Bangalore
KARNATAKA 		 9916922303

arvi03@yahoo.com 
Dr Jothydev Kesavadev  Jothydev Diabetes Centre  JDC Junction, Mudavanmugal, Konkalam, Trivandrum, Kerala-695032
Thiruvananthapuram
KERALA 		 9895040055

jothydev@gmail.com 
Dr Girish Parmar  Kokilaben Dhirubhai Ambani Hospital  Department of Endocrinology, Rao Saheb Achutrao Patwardhan Marg, Patwardhan Marg, Four Bunglows, Andheri West, MUMBAI-400053
Mumbai
MAHARASHTRA 		 9820718088

drgirish21@yahoo.co.in 
Dr Shobha Devi  Life Span Clinics  Road no.1, Aswini colony, West Mareddpally, Secunderabad-500026, Telangana
Hyderabad
ANDHRA PRADESH 		 9866082624

hyddiabetes@gmail.com 
Dr Rajeev Chawla  North Delhi Diabetes Centre  180 , Jai Apartments , Sector 9 Rohini , Delhi -110085
New Delhi
DELHI 		 9811799666

rajeevaastikchawla@yahoo.com 
Dr Shivaa Mohan  Ramkala Diabetes Research Foundation  #57/4, Zubi Manor, 1st Floor, 7th Avenue, Ashok Nagar, Chennai - 83, Tamilnadu
Chennai
TAMIL NADU 		 9094778778

drshivaamohan@gmail.com 
Dr Sanjay Agarwal  Ruby Hall Clinic  Diabetes OPD, 40, Sasoon Road, Pune-411001
Pune
MAHARASHTRA 		 9822091220

drsanjayagarwal@yahoo.co.in 
Dr Sanjay Agarwal  Ruby Hall Clinic  Diabetes OPD, 40, Sasoon Road, Pune 411001
Pune
MAHARASHTRA 		 9822091220

drsanjayagarwal@yahoo.co.in 
Dr Surender Kumar  Sir Ganagram Hospital  Department of Endocrinology ,New Rajinder Nager , Delhi -110060
New Delhi
DELHI 		 9810195147

doctorsuren@yahoo.co.uk 
Dr Sanjeev Pathak  Sumeru Centre  C G Road, Paldi, Near ParimalRailway Crossing, Paldi, Ahmedabad, Gujarat 380007
Ahmadabad
GUJARAT 		 9824030932

sanjeevphatak@hotmail.com 
Dr Vivek Sundaram  Sundaram foundation  Diabetes OPD, No. 17, EVR Road, Puthur, Trichy
Tiruchirappalli
TAMIL NADU 		 9840084835

dr_viveksundaram@yahoo.co.in 
Dr Ravindranath Venkatesan  Trichy Diabetes speciality centre  B-37, Seshadri road, 7th cross east, Thillai nagar, Trichy-620018, Tamil Nadu
Tiruchirappalli
TAMIL NADU 		 9944075898

varale2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 113  
Name of Committee  Approval Status 
Amrita Institute of Medical Sciences_Dr. Harish Kumar  Approved 
Chellaram Foundation_Dr. Shilpa Sule   Approved 
Chellaram Foundatio,Pune  Approved 
Devki Devi Foundation_Dr. Sujeet Jha  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Awadesh Singh  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. B B Kukreja  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Bikas Bhattacharjee  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Debmalya Sanyal   Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. M K Mukhopadhyay  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Mahesh Padsalge  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. P K Bhattacharya  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Ravi K Muppidi  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Sambit Das  Approved 
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Sujoy Majumdar  Approved 
Ethics Committee_Down Town Hospital_Dr. Rupam Das   Approved 
Ethics Committee_Dr. S. Srikanta  Approved 
Ethics Committee_Dr. Y. Sadasiva Rao  Approved 
ILS Hospital Ethics Committee_Dr. Ghanshyam Goyal  Approved 
Institutional Ethics Committee of_Dr. R. Balamurugan   Approved 
Institutional Ethics Committee Poona Medical Research Foundation Dr. Sanjay Aggarwal   Approved 
Institutional Ethics Committee_Dr. Anil Bhansali  Approved 
Institutional Ethics Committee_Dr. Sanjay Agarwal  Approved 
Institutional Ethics Committe_Dr. Manish Gutch   Approved 
JCDC_ Dr. Raghavachary Madhavan  Approved 
JCDC_Dr Anil Kumar Reddy  Approved 
JCDC_Dr Aravinda Jagadeesha   Approved 
JCDC_Dr B M Makkar   Approved 
JCDC_Dr Dakshata Padhye   Approved 
JCDC_Dr Jothydev Kesavadev   Approved 
JCDC_Dr Rajeev Chawla   Approved 
JCDC_Dr Ravindranath Venkatesan   Approved 
JCDC_Dr Rishi Shukla   Approved 
JCDC_Dr Sailesh Lodha   Approved 
JCDC_Dr Sanjeev Pathak   Approved 
JCDC_Dr Shivaa Mohan   Approved 
JCDC_Dr Shobha Devi   Approved 
JCDC_Dr Surendra Kumar Sharma   Approved 
JCDC_Dr Vivek Sundaram   Approved 
JCDC_Dr. Anant Nigam  Approved 
JCDC_Dr. M Shunmugavelu   Approved 
JCDC_Dr. Surya kant Mathur  Approved 
JCDC_Dr. A.S. Senthil Velu  Approved 
JCDC_Dr. Ajay singh   Approved 
JCDC_Dr. Anantharaman R.   Approved 
JCDC_Dr. Aneesh Ghosh  Approved 
JCDC_dr. Archana Sarda  Approved 
JCDC_Dr. Arun R  Approved 
JCDC_Dr. B K Prasad  Approved 
JCDC_Dr. BISWAJIT GHOSH DASTIDAR  Approved 
JCDC_Dr. C M Batra  Approved 
JCDC_Dr. Chandan Sarmah  Approved 
JCDC_Dr. Chandra Prashanth N Y.  Approved 
JCDC_Dr. Chitra Selvan  Approved 
JCDC_Dr. Debasis Saha  Approved 
JCDC_Dr. Deepak Khandelwal  Approved 
JCDC_Dr. Deepak M C  Approved 
JCDC_Dr. DWARKANATH C.S  Approved 
JCDC_Dr. Farishta Faraz  Approved 
JCDC_Dr. Hemraj Chandalia  Approved 
JCDC_Dr. Inderpal Singh Kochar  Approved 
JCDC_Dr. Jagdish Mulchandani  Approved 
JCDC_Dr. Jasjeet Wasir  Approved 
JCDC_Dr. Jayanthy Ramesh  Approved 
JCDC_Dr. Johny Kannampilly  Approved 
JCDC_Dr. K A V Subrahmanyam  Approved 
JCDC_Dr. Kandula Sai  Approved 
JCDC_Dr. Karuna Kanta Barman   Approved 
JCDC_Dr. Kirtikumar MODI  Approved 
JCDC_Dr. Laxmi Lavanya  Approved 
JCDC_Dr. Mala Dharmalingam  Approved 
JCDC_Dr. Mangesh Tiwaskar  Approved 
JCDC_Dr. Manoj Chawla   Approved 
JCDC_Dr. Mohan Badgandi  Approved 
JCDC_Dr. N G Sastry  Approved 
JCDC_Dr. Nadeem Rais   Approved 
JCDC_Dr. Nanditha Arun  Approved 
JCDC_Dr. Navneet Agrawal  Approved 
JCDC_Dr. Neeta Deshpande   Approved 
JCDC_Dr. Nilakshi Deka  Approved 
JCDC_Dr. Rajneesh Mittal  Approved 
JCDC_Dr. Rakesh Sahay  Approved 
JCDC_Dr. Riyaz Mohammed  Approved 
jcdc_Dr. S A Zaidi  Approved 
JCDC_Dr. S Sridhar  Approved 
JCDC_Dr. Sagarika Mukherjee  Approved 
JCDC_Dr. Samar Kumar Bandyopadhyay  Approved 
JCDC_Dr. SAMIT GHOSHAL  Approved 
JCDC_Dr. SANJAY K. Shah  Approved 
JCDC_Dr. Santosh R  Approved 
JCDC_Dr. Shailaja Kale  Approved 
JCDC_Dr. Shunmugavelu Minakshisundaram  Approved 
jcdc_Dr. Snehal Tanna  Approved 
JCDC_Dr. Somashekar Reddy  Approved 
JCDC_Dr. Sonali Patange   Approved 
JCDC_Dr. Soumyabrata Roy Chaudhuri  Approved 
JCDC_Dr. Sruti Chandrasekaran  Approved 
JCDC_Dr. Subir Ray   Approved 
JCDC_Dr. Subodh Chandra  Approved 
JCDC_Dr. Sudhindra Kulkarni  Approved 
JCDC_Dr. Suresh Damodharan  Approved 
JCDC_Dr. Tejas Shah  Approved 
JCDC_Dr. Uday Phadke  Approved 
JCDC_Dr. Vinod Mittal  Approved 
JCDC_Dr. Vipin Talwar  Approved 
JCDC_Dr. Vishal Chopra  Approved 
JCDC_Dr.(Capt.) Nandini Rastogi  Approved 
JCDC_Dr.Piya Thakkar  Approved 
JDC_Dr. Vignesh JP  Approved 
Marwari Hospital & Research Centre_Dr. Dinesh Agarwal  Approved 
Narayana Health Medical Ethics Committee _ Dr. SHIVAPRASAD K S  Approved 
Narayana Health Medical ethics Committee_Dr. Subramanian Kannan   Approved 
Siksha O Anusandhan_Dr. Abhay Sahoo  Approved 
Sir Ganga Ram Hospital_Dr. Surender Kumar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  NA-Product Registry  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Signed patient informed consent;
2. Type 2 diabetes mellitus;
3. Treated with at least 1 OAD for at least 6 months;
4. Legal age of adulthood, but at least ≥18 years;
5. HbA1c >7.0 % and ≤11% within 3 months of study baseline;
6. Physicians’ decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
 
 
ExclusionCriteria 
Details  1. Diabetes mellitus other than type 2;
2. Existing or previous treatment with insulin or other injectable antidiabetic drugs. The
following is allowed:
- Previous short-term insulin treatment due to an intercurrent medical condition,
with treatment duration not exceeding 10 concurrent days in the past year;
- Previous insulin treatment of gestational diabetes, if the patient has discontinued
insulin treatment more than a year ago.
3. Contraindication to insulin glargine U300 according to local product labelling;
4. Pregnancy, breastfeeding or pregnancy planned during the course of the study;
5. Drug or alcohol abuse within the past year;
6. Concomitant disease with life expectancy of less than 1 year;
7. Concomitant participation in a clinical trial
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients achieving the predefined individualized HbA1c goal at 6th month  6th Month 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy endpoints:
1.Percentage of patients achieving the predefined individualized HbA1c goal at Months 3 and 12;
2. Percentage of patients with HbA1c 7% at Months 3, 6 and 12;
3. Percentage of patients achieving an HbA1c 7.5% in patients over 65 years at Month 3, 6 and 12;
4. Percentage of patients reaching predefined individualized HbA1c goal at Months 3, 6 and 12 depending on baseline HbA1c value (8%, 8% to 10% and 10%); 		 3, 6 and 12 months 
 
Target Sample Size   Total Sample Size="4525"
Sample Size from India="1250" 
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   N/A 
Date of First Enrollment (India)   09/03/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/03/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

An observational study to assess effectiveness, safety and health-economic benefits of Toujeo Initiation in type 2 diabetes mellitus patients, which will be conducted for 12 months in 1250 patients across 125 centers in India. Primary outcome is percentage of patients achieving the predefined individualized HbA1c goal at Month 6(If the goal is not defined at baseline, general HbA1c goal of <7.0% will be used). 

 
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