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CTRI Number  CTRI/2015/12/006442 [Registered on: 17/12/2015] Trial Registered Retrospectively
Last Modified On: 29/11/2018
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodegâ„¢ (Insulin Degludec/ insulin aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India  
Scientific Title of Study   A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India  
Trial Acronym  Ryzodeg PMS study 
Secondary IDs if Any  
Secondary ID  Identifier 
NN54014149 ver 1.0 dated 20-Apr-2014  Protocol Number 
U1111-1157-0615  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  
Name  Dr MV Srishyla 
Designation  Director - Clinical, Medical, Regulatory Affairs & Quality, Novo Nordisk India Pvt Ltd 
Affiliation  Novo Nordisk India Pvt Ltd 
Address  Novo Nordisk India Pvt Ltd Plot No.32, 47 - 50, EPIP Area, Whitefield, Bengaluru Karnataka 560066

Bangalore
KARNATAKA
560066
India 
Phone    
Fax    
Email  mvsr@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharathi R 
Designation  Senior Medical Advisor, Novo Nordisk India Pvt Ltd 
Affiliation  Novo Nordisk India Pvt Ltd 
Address  Novo Nordisk India Pvt Ltd Plot No.32, 47 - 50, EPIP Area, Whitefield, Bengaluru Karnataka 560066

Bangalore
KARNATAKA
560066
India 
Phone    
Fax    
Email  bhtr@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk India Private Ltd, Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066, India  
 
Primary Sponsor  
Name  Novo Nordisk India Private Ltd 
Address  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 Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 40  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AK Awasthi  Ajanta Research Centre  Ajanta Research Centre, No. 765, ABC Complex, Kanpur Road, Near Krishna Cinema, Alambagh
Lucknow
UTTAR PRADESH 		 9415063607

drakawasthi@gmail.com 
Dr Rohit Kapoor  Amandeep Hospital  Amandeep Hospital, G.T. Road, Model Town
Amritsar
PUNJAB 		 9815961619

Rohit_kapoor_rohit@yahoo.co.in 
Dr Harish Kumar  Amrita institute of medical sciences and research centre  Amrita institute of medical sciences and research centre, ponekkara P.O,
Ernakulam
KERALA 		 9895545190

harishkumar@aims.amrita.edu 
Dr Jagat Jyoti Mukherjee  Apollo Gleneagles Hospitals  Apollo Gleneagles Hospitals, 58, Circular Canal
Kolkata
WEST BENGAL 		 9836131888

jjmukh@gmail.com 
Dr Debasis Basu  Apollo gleneagles hospitals, Kolkata  Apollo gleneagles hospitals, 58, canal circular road
Kolkata
WEST BENGAL 		 9831256908

drdbasu@yahoo.com 
Dr Kalpana Dash  Apollo hospitals  Apollo hospitals, Clinical Research Department, Room # 1 Apollo hospitals bilaspur, seepat road, lingiadih village
Bilaspur
CHHATTISGARH 		 9827143474

drkdash@rediffmail.com 
Dr Ramesh Goyal  Apollo Hospitals International Limited   Apollo Hospitals International Limited Plot No.1 A, Bhat GIDC Estate, Gandhinagar Gujarat 382428 India
Gandhinagar
GUJARAT 		 9824012438

ramgoyal@yahoo.com 
Dr AJ Asirvatham  Asirvatham Hospitals  Asirvatham Hospitals 42-a, Kuruvikaran Salai, Gandhi Nagar, Gandhi Nagar, Madurai, Tamil NAdu-625050
Madurai
TAMIL NADU 		 9443751977
04522531977
drajasirvatham@yahoo.co.in 
Dr Norman Sharma  Choithram Hospitals  Choithram Hospitals,14 Manik Bagh Rd
Indore
MADHYA PRADESH 		 9755043881

norman_sharma@hotmail.com 
Dr Sandeep Julka  Convenient Hospitals,  Convenient Hospitals, A.B. Road, Near L.I.G Square, Indore
Indore
MADHYA PRADESH 		 9977999687

sandeep_julka@yahoo.com 
Dr Nanditha Ramachandran  Dr. A. Ramachandrans Diabetes Hospitals  Dr. A. Ramachandrans Diabetes Hospitals No.28, Marshalls Road, Rukmani Lakshmipathy Salai, Egmore Chennai Tamil Nadu 600008  India
Chennai
TAMIL NADU 		 9841002813

ramachandran@ardiabetes.org 
Dr Srikanth K  Endolife Specialty Hospital  Endolife Specialty Hospital D.No 12-12-94, Old Club Road, Kotha Peta Guntur Andhra Pradesh 522001
Guntur
ANDHRA PRADESH 		 9849945577
08636638160
srikanthendo@gmail.com 
Dr Sailesh Lodha  Eternal Heart Care Centre  Eternal Heart Care Centre, 3A, Near Jawahar Circle, Jagatpura Road, Jagatpura,
Jaipur
RAJASTHAN 		 9829019055

saileshlodha@rediffmail.com 
Dr Ankur Gahlot  Fortis Hospital  Fortis Hospital, Jawaharlal Nehru Marg, Malviya Nagar, Near Jawahar Circle
Jaipur
RAJASTHAN 		 7597210207

dr.a.gahlot77@gmail.com 
Dr Ajay aggarwal  Fortis hospitals   Fortis hospitals,14, cunningham road
North East
DELHI 		 9910258977

ajay2268@gmail.com 
Dr Ambana Gowda  Fortis hospitals Ltd  Fortis hospitals Ltd, 14, cunningham road
Bangalore
KARNATAKA 		 9845270377

dr.ambanagowda@gmail.com 
Dr Kiran Pal Singh  Fortis medcentre  Fortis medcentre SCO 56-57, Sector 9 D Chandigarh Punjab 160017 India
Chandigarh
CHANDIGARH 		 9815311711
0172-4692219
k.singh@fortishealthcare.com 
Dr Baraneedharan  Global hospitals  Global hospitals,#439, Cheran nagar, perumbakkam
Chennai
TAMIL NADU 		 9841113009

way2baranee@gmail.com 
Dr Abhay Mutha  Grant Medical Foundation, Ruby Hall Clinic  Grant Medical Foundation, Ruby Hall Clinic 40 Sassoon Road,Pune Maharastra 411001 India
Pune
MAHARASHTRA 		 9823037900
02066455628
medrabhaymutha@gmail.com 
Dr Jothydev Kesavadev  Jothydevs Diabetes and Research Center  Jothydevs Diabetes and Research Center, JDC Junction, Mudavanmugal, Konkalam, Poojapura
Thiruvananthapuram
KERALA 		 9447040055

jothydev@gmail.com 
Dr MC Deepak  KHM Hospital  KHM Hospital AB-14/4907, Balasubramanian Building,Opp. Sri Ayyappa Temple, 6th Main Road, Anna Nagar Chennai Tamil Nadu 600040 India
Chennai
TAMIL NADU 		 9790928158

drdiabdeepak@gmail.com 
Dr B Vivekanand  King george hospital  King george hospital, super speciality block, maharani peta
Visakhapatnam
ANDHRA PRADESH 		 9440514756

drvivek_78@yahoo.com 
Dr Prabha Adhikari  KMC Hospital  KMC Hospital Attavar,Mangalore Karnataka 575001 India
Dakshina Kannada
KARNATAKA 		 9880991290

prabha.raghuveer@gmail.com 
Dr Dheeraj Kapoor  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows
Mumbai (Suburban)
MAHARASHTRA 		 9324718345

drdkapoor@yahoo.co.uk 
Dr Balamurugan  Kovai Diabetes Specialty Centre & Hospital  Kovai Diabetes Specialty Centre & Hospital,Shop No.15, Vivekananda Rd, Ram Nagar
Coimbatore
TAMIL NADU 		 9842244881

balamurugan_dr@gmail.com 
Dr Nehal Sadhu  Krishna Shalby Hospital,  Krishna Shalby Hospital,319, Green City, Ghuma, Via Bopal,
Ahmadabad
GUJARAT 		 9824550005

drnehalsadhu@yahoo.com 
Dr L Sreenivasa Murthy  Lifecare clinic  Lifecare clinic, #2748/2152 M.L.N enclave, 16th ‘E’ crossroad, 8thmain, ‘D’ block, next to corporation bank, Sahakarnagar
Bangalore
KARNATAKA 		 9972308981

drlsm@lcrc.in 
Dr Thomas Paul   Madonna hospital and diabetic research centre  Madonna hospital and diabetic research centre,Aluva road
Ernakulam
KERALA 		 9388604125

drtpmadonna@gmail.com 
Dr Manoj Kumar Shah  MMM Hospital  MMM Hospital, 4-A, Dr J Jayalalitha Nagar, Mogappair
Chennai
TAMIL NADU 		 914426565974

drkmanoj.diab@gmail.com 
Dr PM Jayaraj  Mother hospital  Mother hospital, pullazi, olarikkara
Thrissur
KERALA 		 9447000134

jnephro@gmail.com 
Dr Sandeep Kumar Gupta  MV Hospital and Research Centre  MV Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk
Jaipur
RAJASTHAN 		 9415026054

sandeepkumar.gupta@rediffmail.com 
Dr Piyush Desai  Nirmal Hospital Private Limited  Nirmal Hospital Private Limited, Ring Road
Surat
GUJARAT 		 9825144453

drpiyushdesai@gmail.com 
Dr Sreejith N Kumar  Noorul Islam Institute of Medical Sciences and Research Foundation  NIMS Medicity , Aralummodu, Neyyanttinkara, Trivandrum-695123, Kerala
Thiruvananthapuram
KERALA 		 9847204360

drsnkumar@gmail.com 
Dr Josemon Thomas  PRS hospital  PRS hospital,Killipalam
Thiruvananthapuram
KERALA 		 9447016570

jmt529@gmail.com 
Dr Kamlesh Fatania  Rathi Hospital  Rathi Hospital, Near Anupam Shopping Centre, Opp Mahabaleshwar Society, Jodhpur Cross Roads, Satellite
Ahmadabad
GUJARAT 		 9879537973

vivekarya007@yahoo.com 
Dr Vivek Arya  Sanjivani Superspecialty Hospitals,   Sanjivani Superspecialty Hospitals, 1, Uday Park Society, Near Sunrise Park, Vastrapur
Ahmadabad
GUJARAT 		 9879537973

vivekarya007@yahoo.com 
Dr Navneet Shah  Sterling Hospital   Sterling Hospital Sterling Hospital Road, Near Gurukul, Near Agracent High School, Memnagar Ahmedabad Gujarat 380052 India
Ahmadabad
GUJARAT 		 9824030544

navneetnshah2000@gmail.com 
Dr Ashok Khatri  Sushri Jasumatiben shantilal surti charitable general hospital   Sushri Jasumatiben shantilal surti charitable general hospital (run by thakershy charitable trust ) DHL research centre, opposite Vimananagar, near shivaranjani cross road, satellite
Ahmadabad
GUJARAT 		 9377439343

draskhatri@yahoo.com 
Dr Padmanaba Zinzuwadiya  Sushri Jasumatiben shantilal surti charitable general hospital   Sushri Jasumatiben shantilal surti charitable general hospital (run by thakershy charitable trust ) DHL research centre, shivranjini char rasta opp Bima Nagar, satellite,ambavadi
Ahmadabad
GUJARAT 		 9377439343
9377439343
draskhatri@yahoo.com 
Dr Sadasiva Rao  Yalamanchi Hospital  Yalamanchi Hospital No. 29-7-44, Venkatratnam Street, Suryaraopet Vijayawada Andhra Pradesh 520002 India
Krishna
ANDHRA PRADESH 		 9848132230
0866-2435988
drsada@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 40  
Name of Committee  Approval Status 
Institutional Ethics Committee, Arthur Asirvatham Hospital  Approved 
Apollo Hospitals International Ltd Ethics Committee Office,  Approved 
Choithram Hospital & Research Centre, Ethics Committee  Approved 
Ethics Committee  Approved 
Ethics Committee Jothydevs Diabetes and Research Center  Approved 
Ethics Committee KHM Hospital   Approved 
Ethics Committee of India Diabetes Research Foundation & Dr. A.Ramachandran’s Diabetes Hospitals   Approved 
Ethics Committee, Ajanta Hospital and IVF Center   Approved 
Ethics Committee, Apollo Hospital  Approved 
Ethics Committee, Endolife Speciality Hospitals Pvt. Ltd  Approved 
Ethics Committee, Eternal Heart Care Centre and Research Institute   Approved 
Ethics Committee, Krishna Shalby Hospital   Approved 
Ethics Committee, PRS Hospital  Approved 
Ethics Committee, Yalamanchi Hospita  Approved 
Fortis Hospital Ethics Committee   Approved 
Institutional Scientific and Ethics Board (ISEB) Medical Research Department  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Madonna Hospital & Research Centre   Approved 
Institutional Ethics Committee for MV Hospital And Research Centre  Approved 
Institutional Ethics Committee Fortis Hospital   Approved 
Institutional Ethics Committee Fortis Hospital   Approved 
Institutional Ethics Committee Global Hospitals and Health City  Approved 
Institutional Ethics Committee Mother Hospital (P) Ltd  Approved 
Institutional Ethics Committee of Kovai Diabetes Specialty Centre and Hospital  Approved 
Institutional Ethics Committee, Amrita Institute of Medical and Research Centre, AIMS   Approved 
Institutional Ethics Committee, Apollo Gleneagles Hospital, Kolkata  Approved 
Institutional Ethics Committee, Apollo Gleneagles Hospital,Kolkata  Approved 
Institutional ethics Committee, Noorul Islam Institute of Medical Sciences(NIMS) & Research Foundation  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation Pune   Approved 
Institutional Ethics Committee, Rathi Hospital  Approved 
Institutional Ethics Committee, Sterling Hospital  Approved 
Instiutional Ethics Committee   Approved 
Integrity Ethics Committee , Convenient Hospitals Ltd   Approved 
Lifecare Ethics Committee   Approved 
Manipal University Ethics Committee  Approved 
Nirmal Hospital Private Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee 1  Approved 
Thakershy Charitable Trust Ethics Committee  Approved 
Thakershy Charitable Trust Ethics Committee, Sushri Jasumatiben Shantilal Surti Charitable General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Diabetes Mellitus , (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  RyzodegTM FlexTouchTM in a prefilled pen injector (100 U/mL)  Insulin degludec/ insulin aspart for once or twice daily subcutaneous injection or as per prescribing information 52 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  "1. Informed consent obtained before any study-related activities. (Study- related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c, FPG, PPPG, severe hypoglycaemia before the start of Ryzodegâ„¢ therapy) can be used for baseline data

2. Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodegâ„¢ based on the clinical judgment of their treating physician.

3. More than 18 years old, male / female patients"
 
 
ExclusionCriteria 
Details  "1. Known or suspected allergy to Ryzodegâ„¢ any of the active substances or any of the excipients
2. Previous participation in this study
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Patients who are or have previously been on Ryzodegâ„¢ therapy.
5. Patients who are participating in other studies or clinical trials
6. Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months"
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of long-term treatment with insulin degludec/ insulin aspart (Ryzodegâ„¢) in insulin requiring patients with diabetes mellitus, initiating treatment with Ryzodegâ„¢ under routine clinical practice in India.
 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess efficacy and additional safety of long term (1 year) treatment with Ryzodegâ„¢
 		 1 year 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "976"
Final Enrollment numbers achieved (India)="976" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   24/11/2015 
Date of Study Completion (India) 01/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
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
Modification(s)  		 A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India. 
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