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CTRI Number  CTRI/2015/12/006437 [Registered on: 11/12/2015] Trial Registered Prospectively
Last Modified On: 29/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan 
Scientific Title of Study   34-week, randomised (1:1), parallel group, two-arm, open-label, multicentre, multinational, controlled trial comparing the efficacy and safety of IDegAsp BID vs. BIAsp 30 BID with respect to change in HbA1c from baseline to end of treatment, both with or without OAD(s) before, during and after Ramadan in subjects with T2DM who have expressed their intention to fast during Ramadan 
Trial Acronym  Ryzodeg Ramadan 
Secondary IDs if Any  
Secondary ID  Identifier 
NN5401-4243 Protocol Version 2.0 dated 30 Sep 2015 final  Protocol Number 
UTN: U1111-1170-8304  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M A Shekar 
Designation  Professor of Medicine and Head, Department of Endocrinology 
Affiliation   
Address  Mysore Medical College and Research Institute, Dept. of endocrinology, K.R. hospital, MMC & RI, Irwin road, Mysore-01

Mysore
KARNATAKA
570001
India 
Phone  9845120106  
Fax    
Email  drsheki@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MV Srishyla 
Designation  Director, Clinical, Medical, Regulatory and Quality 
Affiliation  Novo Nordisk 
Address  Novo Nordisk India Private Ltd. "Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka 560 006

Bangalore
KARNATAKA
560 006
India 
Phone  8861082266  
Fax  080-41123517  
Email  mvsr@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Avik Kumar Ghosh 
Designation  Head, Clinical Operations 
Affiliation  Novo Nordisk 
Address  Novo Nordisk India Private Ltd. "Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka 560 006

Bangalore
KARNATAKA
560 006
India 
Phone  9731188991  
Fax  080-41123517  
Email  avkg@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk AS  
 
Primary Sponsor  
Name  Novo Nordisk 
Address  Novo Nordisk India Private Ltd."Plot No.32, 47 - 50, EPIP Area, Whitefield" Bangalore,Karnataka 560 006  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Algeria
India
Lebanon
Malaysia
South Africa
United Arab Emirates  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Satesh Chawla  B.S.E.S MUNICIPAL GENERAL HOSPITAL  "B.S.E.S MUNICIPAL GENERAL HOSPITAL, S.V.ROAD. OPP. RAILWAY STATION, ANDHERI(WEST), MUMBAI- 400 058 "
Mumbai
MAHARASHTRA 		 9820002333
022-26302623
linadiabetes@gmail.com 
Dr P K Kundu  Calcutta School of Tropical Medicine (CSTM  Calcutta School of Tropical Medicine (CSTM), 108, Chittaranjan Avenue, Kolkata 700073
Kolkata
WEST BENGAL 		 9433509267

drpkkundu@rediffmail.com 
Dr Neeraj Manikath  Calicut Medical College  Dept. of General medicine, Calicut Medical College, Medical College P.O, Calicut-673 008
Kozhikode
KERALA 		 9447391055

nmanikath@gmail.com 
Dr Shubhalaxmi Margekar  Lady Hardinge Medical College  Room No: 1014 Department of Medicine, Old Building Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi- 100 001 "
New Delhi
DELHI 		 9540364032

dr_shubhalaxmi@rediffmail.com 
Dr Faraz Farishta  Medwin Hospital  Medwin Hospital, 100, Raghava Ratna Towers, Nampally, Hyderabad, Telangana 500001
Hyderabad
ANDHRA PRADESH 		 09885035977

drfarazfarishta@gmail.com 
Dr M A Shekar  Mysore Medical College and Research Institute   Mysore Medical College and Research Institute and Associated Hospitals
Mysore
KARNATAKA 		 9845120106

drsheki@gmail.com 
Dr Mohd Abubaker  Owaisi Hospital & Research Centre  Owaisi Hospital & Research Centre, P.O. KANCHANBAGH, DMRL X ROAD, Santoshnagar, Hyderabad
Hyderabad
ANDHRA PRADESH 		 9848025211

drabubakar2004@gmail.com 
Dr Shehla Shaikh Akhtar  Prince Aly Khan Hospital  Prince Aly Khan Hospital, Aga hall, Nesbit road, Mazagaon, Mumbai 400010
Mumbai
MAHARASHTRA 		 9820984842

drshehlas@gmail.com 
Dr Abhay Mutha  Ruby Hall Clinic Services Pvt. Ltd  Ruby Hall Clinic Services Pvt. Ltd., E4C/E4F, Soraj Building, 5th avenue condomonium, 4th floor. Dhole aptil road, Pune 411001
Pune
MAHARASHTRA 		 9823037900

drabhaymutha@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
 Institutional Ethics Committee, Calicut Medical College, Dr Neeraj Manikath  Approved 
BSES Municipal General Hospital Ethics Committee, Dr Manoj Chawla  Approved 
CLINICAL RESEARCH ETHICS COMITEE(CREC-STM).SCHOOL OF TROPICAL MEDICINE, Dr Prabir Kumar Kundu  Submittted/Under Review 
Ethics Committee for Human Research, Lady Hardinge Medical College, Dr Shubhalaxmi Margekar  Approved 
Institutional Ethics Committee Medwin Hospitals, Hyderabad  Approved 
Institutional Ethics Committee Poona Medical Research Foundation, Dr Abhay Mutha   Approved 
Institutional Ethics Committee,Deccan College of Medical Sciences & Allied Hospitals  Approved 
Institutional Ethics Committee-Mysore Medical College and Research nstitute and Associated Hospitals  Approved 
Prince Aly Khan Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biphasic Insulin Aspart  Biphasic Insulin Aspart Dose: Subject will star on the same dose of insulin units as taking before the screening visit, its unit to unit switch. Frequency route of administration: Sub cutaneous TOTAL duration of therapy : entire treatment period is 24 weeks  
Intervention  Insulin Degludec Plus   Insulin Degludec Plus - Ryzodeg Dose: Subject will star on the same dose of insulin units as taking before the screening visit, its unit to unit switch. Frequency route of administration: Sub cutaneous TOTAL duration of therapy : entire treatment period is 24 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  "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 diagnosed with T2DM (diagnosed clinically) ≥ 24 weeks prior to day of screening
(V1).
4. Subjects who have expressed their intention to fast (daytime, i.e., between dawn and sunset)
during Ramadan after receiving medical counselling regarding the risk of fasting.
5. Subjects who are willing to give blood during Ramadan.
6. Subjects treated with any premix/selfmix or basal insulin regimen ≥ 90 days prior to the day of
screening (V1).
7. Subjects who are on stable daily dose(s) including any of the following anti-diabetic
drug(s)/regimens within 90 days prior to the day of screening (V1):
a. Biguanides (metformin ≥ 1500 mg or maximum tolerated dose documented in the
subject medical record)
b. Insulin secretagogues (sulfonylureas and glinides), DPP-4 inhibitors, α-glucosidase
inhibitors, SGLT-2 inhibitors (≥ half of the maximum approved dose according to
local label or Maximum Tolerated Dose as documented in subject medical record)
8. HbA1c 7.0%-10.0% (53-86 mmol/mol)(both inclusive, by central laboratory analysis).
9. Body mass index (BMI) ≤ 45.0 kg/m2.
10. Subjects who are able and willing to adhere to the protocol including self-measurement of
plasma glucose according to the protocol"
 
 
ExclusionCriteria 
Details  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 adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
4. Receipt of any investigational medicinal product within 4 weeks prior to the day of screening (Visit 1)
5. Any disorder, which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
6. Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening (Visit 1)
7. Renal impairment estimated as the Glomerular Filtration Rate (eGFR) 60 mL/min (defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening (Visit 1)
8. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) in the previous 90 days prior to the day of the screening
9. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1)
10. Subjects presently classified as being in New York Heart Association (NYHA) Class IV on the day of screening (Visit1)
11. Planned coronary, carotid or peripheral artery revascularisation on the day of screening (Visit 1)
12. Inadequately treated blood pressure as defined as Class 2 hypertension or higher (systolic ≥160 mmHg or diastolic ≥100 mmHg) at screening (Visit 1)
13. Treatment with any medication for the indication of diabetes or obesity other than those stated in the inclusion criteria in a period of 90 days before the day of screening (Visit 1)
14. Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on an frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
15. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation (Visit 2)
16. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
17. Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening (Visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (Visit 1), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HbA1c (%) from baseline   (week 0) to end of Ramadan (day 29 of Ramadan 
 
Secondary Outcome  
Outcome  TimePoints 
To compare efficacy parameters, safety and patient reported outcomes (PROs) of IDegAsp BID and BIAsp 30 BID  (week 0) to end of Ramadan (day 29 of Ramadan) 
 
Target Sample Size   Total Sample Size="357"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "247"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/01/2016 
Date of Study Completion (India) 01/09/2016 
Date of First Enrollment (Global)  04/01/2016 
Date of Study Completion (Global) 05/09/2016 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A trial comparing efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart  twice daily in subjects with type 2 diabetes mellitus before, during and after Ramadan. Globally 6 countries are participating.

 

 

 

 
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