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CTRI Number  CTRI/2015/05/005769 [Registered on: 13/05/2015] Trial Registered Retrospectively
Last Modified On: 21/04/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to assess the prevalence of chronic kidney disease in Type 2 Diabetes. 
Scientific Title of Study   An Observational, Cross sectional Study to assess the prevalence of chronic kidney disease in Type 2 Diabetes Patients in India 
Trial Acronym  START- India 
Secondary IDs if Any  
Secondary ID  Identifier 
D1843R00050  Protocol Number 
NCT02208921  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasanna Kumar KM 
Designation  M.B.B.S, M.D, D.M. 
Affiliation  Endocrinology 
Address  Center for Diabetes and Endocrine Care 410/A, I Stage, III Block, HBR Layout, Near BDA Complex, Kalyanangar Post

Bangalore
KARNATAKA
560043
India 
Phone  00918025440011  
Fax    
Email  dr.kmpk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hardik Vasnawala 
Designation  Study Physician 
Affiliation  AstraZeneca Pharma India Limited 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rechenahalli, Outer Ring Road, Bangalore-560045

Bangalore
KARNATAKA
560045
India 
Phone  00918067748000  
Fax    
Email  hardik.vasmawala@astrazeneca.com  
 
Details of Contact Person
Public Query  
Name  Mr Amit Kumar 
Designation  Study Leader  
Affiliation  AstraZeneca Pharma India Limited 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rechenahalli, Outer Ring Road, Bangalore-560045

Bangalore
KARNATAKA
560045
India 
Phone  00918067748560  
Fax  00918023622015  
Email  amit.kumarAK@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Ltd. 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rechenahalli, Outer Ring Road, Bangalore-560045 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 30  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Prasad  Fortis Hospital  B-22, Sector-62, Noida, Uttar Pradesh -201301, Department: Endocrinology
Gautam Buddha Nagar
UTTAR PRADESH 		 9871125907

dr_rakesh_k@outlook.com 
Dr R N Mehrotra  Apollo Hospital Sugar Clinic  Department of Endocrinology, Jubilee Hills, Hyderabad-500096 Department: Endocrinology
Hyderabad
ANDHRA PRADESH 		 9490267373

ravinm1@rediffmail.com 
Dr Prasanna Kumar KM  Center for Diabetes and Endocrine Care  410/A, I Stage, III Block, HBR Layout, Bangalore, Karnataka 560043 Department: Endocrinology
Bangalore
KARNATAKA 		 08025440011

dr.kmpk@gmail.com 
Dr Rishi Sukla   Centre for Diabetes & Endocrine Diseases  113/14, Shahi Darbar Apartment, Swaroop Nagar, Kanpur-208002, Uttar Pradesh Department: Endocrinology
Kanpur Nagar
UTTAR PRADESH 		 9415042286

drrishishukla@gmail.com 
Dr Sanjeev Ratnakar Phatak  D H L Research Center   Shivranjani Cross Road, Satellite, Ahmedabad-380015, Gujarat Department: Endocrinology
Ahmadabad
GUJARAT 		 9824030932

phatak_sanjeev@yahoo.co.in 
Dr Vaishali Deshmukh  Deshmukh Clinic & Research Centre  Mulay Arcade 2nd Floor, Tilak Road, Pune-411030, Maharashtra Department: Endocrinology
Pune
MAHARASHTRA 		 9850811450

docvaishali@yahoo.co.in 
Dr B M Makkar  Diabetes & Obesity Centre  A-5B/122, Paschim Vihar, New Delhi-110063 Department: Endocrinology
New Delhi
DELHI 		 9910047419

drbmmakkar@yahoo.com 
Dr Abhay Mutha  Diabetes Care & Research Centre  B5 Mittal Court, 478 Rasta Peth, Pune 411011, Maharashtra Department: Endocrinology
Pune
MAHARASHTRA 		 9823037900

drabhaymutha@gmail.com 
Dr Nadiminty G Sastry  Dr. Mohan’s Diabetes Centre  Domolguda, Hyderabad – 500029 Department: Endocrinology
Chennai
TAMIL NADU 		 9848619247

ngsastry@gmail.com 
Dr Vijay Panikar  Dr. Panikar’s Speciality Care Centre  Siddhart Housing Colony, Bandra, Mumbai-400051, Maharashtra Department: Endocrinology
Mumbai
MAHARASHTRA 		 9322281407

drvijaypanikar@yahoo.com 
A Sharda  Endocrinology Diabetes centre  No. 640, Indiranagar, Bangalore-560038, Karnataka Department: Endocrinology
Bangalore
KARNATAKA 		 9448063156

sharda.a@gmail.com 
Dr R Muralidharan  Fortis Mohali  Sector 62, Phase – VIII Mohali, Punjab-160062, India Department: Endocrinology
Patiala
PUNJAB 		 9815094341

muraliendo@yahoo.com 
Dr Vinay Bhat  Harmukh Clinic  C-13, Shalimar Garden Extension, Sahibabad, Ghaziabad – 201010, Uttar Pradesh Department: Endocrinology
Ghaziabad
UTTAR PRADESH 		 9810328472

vmbhat@gmail.com 
Dr Pankaj Agarwal  Hormone Care and Research Centre  SB-5, Shastri Nagar Ghaziabad, Uttar Pradesh – 201002 Department: Endocrinology
Ghaziabad
UTTAR PRADESH 		 9810125568

hormonecareghaziabad@rediffmail.com 
Dr Shailaja Kale   Inamdar Multispeciality Hospital  Survey No. 15, Fatima Nagar, Pune-411040, Maharashtra Department: Endocrinology
Pune
MAHARASHTRA 		 9822055458

drshailaja@yahoo.com 
Dr Jothydev Kesavadev  Jothydevs Diabetes and Research Centre  JDC Junction, Konkalam Road Mudavanmugal, Trivandrum-695032, Kerala Department: Endocrinology
Thiruvananthapuram
KERALA 		 9895040055

jothydev@gmail.com 
Dr Shehla Shaikh   K G N Diabetes & Endocrinology Centre  Shop No 10, 1st Floor, Patel Arcade, -Mumbai Central, Mumbai Department: Endocrinology
Mumbai
MAHARASHTRA 		 9820984842

drshehlas@gmail.com 
Dr G G Jayram Naidu  KG Hospital & Post Graduate Medical Institute  Coimbatore-641018 Department: Endocrinology
Coimbatore
TAMIL NADU 		 9443170088

drgirimd@yahoo.com 
Dr MC Deepak  Madhav Diabetes Centre  AA2, Anna Nagar , Chennai-600040 Department: Endocrinology
Chennai
TAMIL NADU 		 9790928158

drdiabdeepak@gmail.com 
Dr Anant Nigam  Nigam Diabetes Centre  A-46 Bajaj Nagar Jaipur-302015, Rajasthan Department: Endocrinology
Jaipur
RAJASTHAN 		 9828166544

dranigam@gmail.com 
Dr Samit Ghosal  Nightingale Hospital  Nightingale Diagnostic & Medicare Centre Pvt. Ltd., 11, Shakespeare Sarani, Kolkata-700071, West Bengal Department: Endocrinology
Kolkata
WEST BENGAL 		 9903040278

ramdasghosal@gmail.com 
Dr Surender Kumar  Nobel Medicare  C2B/62A, Janak Puri, New Delhi – 110058 Department: Endocrinology
New Delhi
DELHI 		 9810195147

doctorsuren@yahoo.co.uk 
Dr Rajeev Chawla   North Delhi Diabetes Centre  180 Jai Apartments, Sector 9, Rohini, New Delhi-110085
North
DELHI 		 9811799666

rajeevaastikchawla@yahoo.com 
Dr Rajesh Rajput  PGIMS  Rohtak-124001, Haryana. Department: Endocrinology
Rohtak
HARYANA 		 9996013454

drrajeshrajput@outlook.com 
Dr Yogesh Kadam  Poona Diabetes Centre  Gulmohar Apartments, Ground Floor, Pune-411001, Maharashtra Department: Endocrinology
Pune
MAHARASHTRA 		 9823141402

dryogeshdkadam@gmail.com 
Dr Sanjay Gupta   SG Diabetes Centre  123-D, Kamla Nagar, Delhi-110007 Department: Endocrinology
North
DELHI 		 9811159078

sg_dg@yahoo.co.in 
Dr Krishna Seshadri  Sri Ramachandra Medical College Chennai  Department: Endocrinology
Chennai
TAMIL NADU 		 04445928661

krishnagseshadri@gmail.com 
Dr Vageesh Ayyar S  St. John’s Medical College & Hospital  Koramangala, Bangalore-560034, Karnataka Department: Endocrinology
Bangalore
KARNATAKA 		 9341669652

vagayyar@gmail.com 
Dr P G Talwalkar  Talwalkar Diabetes Clinic  Saraswati Mahal, 1st Floor, Junction of Gokhale & Ranade Road, Dadar, Mumbai- 400028 Department: Endocrinology
Mumbai
MAHARASHTRA 		 9820281806

pg_talwalkar@hotmail.com 
Dr Sujit Bhattacharya  The Calcutta Medical Research Institute  7/2, Diamond Harbour Road, Kolkata-700027, West Bengal Department: Endocrinology
Kolkata
WEST BENGAL 		 9874292170

sujit_dr@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 30  
Name of Committee  Approval Status 
Apollo Hospital, Hyderabad, Ethics Committee-Apollo Hospital, Apollo Health City, Jubilee Hills, Hyderabad-500096  Not Applicable 
Center for Diabetes and Endocrine Care, Bangalore Diabetes Hospital Ethics Committee, Bangalore   Not Applicable 
Centre for Diabetes & Endocrine Diseases, Uttar Pradesh Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
D H L Research Center , Ahmedabad-380015, Gujarat, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Deshmukh Clinic & Research Centre Pune-411030, Maharashtra Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Approved 
Dhanvantari Hospital & Research Centre, Mumbai-400028, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Diabetes & Obesity Centre, New Delhi-110063 Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Diabetes Care & Research Centre, Pune 411011, Maharashtra Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Dr. Mohan’s Diabetes Centre, Hyderabad , Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Dr. Panikar’s Speciality Care Centre Mumbai-400051, Maharashtra Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Endocrinology Diabetes centre, EC Science for Health, No 2, 1A Cross, Marenahalli, JP Nagar, 2nd Phase, Bangalore-560078, Karnataka  Not Applicable 
Fortis Hospital, Noida, Uttar Pradesh -201301, Fortis Hospital, Institutional Ethics Committee, B-22, Sector-62, Noida-201301, Uttar Pradesh  Not Applicable 
Fortis Mohali Mohali, Punjab-160062, India INSTITUTIONAL ETHICS COMMITTEE Fortis Mohali Sector 62, Punjab-160062, India   Not Applicable 
Harmukh Clinic Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Hormone Care research Centre Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Inamdar Multispeciality Hospital, Pune-411040, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Jothydevs Diabetes and Research Centre Trivandrum Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
K G N Diabetes & Endocrinology Centre, Mumbai Central, Mumbai Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
KG Hospital & Post Graduate Medical Institute, Coimbatore, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore  Not Applicable 
Madhav Diabetes Centre, Chennai Tamilnadu, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore  Not Applicable 
Nigam Diabetes Centre, Jaipur-302015, Rajasthan Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Nightingale Hospital, Nightingale Diagnostic & Medicare Centre Pvt. Ltd.,11. Kolkata-700071, Institutional Ethics Committee Nightingale Hospital, 11 Shakespeare Sarani, Kolkata-700064  Not Applicable 
Nobel Medicare, New Delhi, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
North Delhi Diabetes Centre, New Delhi, Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
PGIMS Rohtak-124001, Haryana Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Poona Diabetes Centre, Pune-411001, Maharashtra Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
SG Diabetes Centre elhi-110007 Clinicom, Independent Ethics Committee. “Sushruta”, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore-560003, Karnataka  Not Applicable 
Sri Ramachandra Medical Centre, Chennai, Institutional Ethics Committee, Sri Ramachandra University, No. 1 Ramachandra Nagar, Porur, Chennai-600116, Tamilnadu  Not Applicable 
St. John’s Medical College & Hospital, Institutional Ethics Committee, St. John’s National Academy of Health Sciences, 1st Floor, Zablocki Learning Center (St. John’s Library), St. John’s Medical College, Sarjapur Road, Bangalore-560034, Karnataka  Not Applicable 
The Calcutta Medical Research Institute, Kolkata-700027 Institutional Ethics Committee, The Calcutta Medical Research Institute-7/2, Diamond Harbour Road, Kolkata-700027, West Bengal  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Known cases of T2DM.
• Male and female patients aged 18 years and above
• Must provide written Informed consent.
 
 
ExclusionCriteria 
Details  • Patients with known type-1 diabetes.
• Patients with any form of acute kidney injury based on investigator’s discretion.
• Patients on maintenance dialysis or known renal transplant patients.
• Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of Chronic Kidney Disease in patients with T2DM.  single visit study (1 day) 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the proportion of T2DM patients in various Categories of GFR
2. To estimate the proportion of CKD in T2DM patients with different duration of diabetes since diagnosis.
3. To estimate the HbA1c goal achievement in patients with and without CKD.
4. To observe anti-diabetic treatment and their association with renal failure.
 		 single visit study (1 day) 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/09/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 diabetes.  Approx 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects.  All the procedures will be completed in a single day.

 
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