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CTRI Number  CTRI/2021/06/034231 [Registered on: 14/06/2021] Trial Registered Prospectively
Last Modified On: 06/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Other details( dose, duration, frequency, route of administration,etc)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen. ONWARDS 4. 
Scientific Title of Study   A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insulin. 
Trial Acronym  ONWARDS 4 
Secondary IDs if Any  
Secondary ID  Identifier 
NN1436-4480  ClinicalTrials.gov 
NN1436-4480 V3.0 Final Dated 30 November 2020  Protocol Number 
U1111-1247-5269  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Tandon 
Designation  Endocrinologist 
Affiliation  AIIMS 
Address  AIIMS All India Institute of Medical Sciences Sri Aurobindo Marg
Ansari Nagar Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India 
Phone  9818211663  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Maya Sharma 
Designation  Sr. Director - CMR 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50, EPIP Area, Whitefield
Bangalore
KARNATAKA
560066
India 
Phone  9911497869  
Fax    
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Maya Sharma 
Designation  Head Clinical Operations 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50, EPIP Area, Whitefield
Bangalore
KARNATAKA
560066
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk Denmark 
 
Primary Sponsor  
Name  Novo Nordisk Denmark 
Address  A/S-Novo Alle, 2880 Bagsvaerd Denmark 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Novo Nordisk India  Novo Nordisk -Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka-560 066 
 
Countries of Recruitment     Belgium
India
Japan
Mexico
Netherlands
Romania
Russian Federation
United States of America
Italy  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shehla Shaikh  Prince Aly Khan Hospital,  Prince Aly Khan Hospital, Nesbit Rd, Mazagon, Mumbai, Maharashtra 400706, India
Mumbai
MAHARASHTRA 		 9820984842

drshehla@rediffmail.com 
Dr Nikhil Tandon  All India Institute of Medical Sciences  AIIMS-All India Institute of Medical Sciences Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India
New Delhi
DELHI 		 9818211663

nikhil_tandon@hotmail.com 
Dr Parmesh Shamanna  Bangalore Diabetes Centre  Bangalore Diabetes Centre 426, 4th Cross, 2nd block, Kalyananagar Bangalore 560043
Bangalore
KARNATAKA 		 9845010610

drparamesh2@gmail.com 
Dr Manoj Chawla  BSES Hospital  B.S.E.S Municipal General Hospital, S.V. Road (Opp. Railway Station), Lohana Colony, Andheri (W), Mumbai- 400058, India
Mumbai
MAHARASHTRA 		 9820002333

drmanojchawla@yahoo.com 
Dr Sk Sharma  DTEC-Diabetes, Thyroid and Endocrine Centre  Diabetes, Thyroid and Endocrine Centre, A1, Madrampura, ajmer Road, Near 4 no. ESI Hospital , Sodala, Jaipur, 302006, Rajasthan , India
Jaipur
RAJASTHAN 		 9829010233

sksharmacr@gmail.com 
Dr Sanjay C Agarwal  Grant Medical Foundation Ruby Hall Clinic  Grant Medical Foundation, Ruby Hall Clinic, #40,Sasoon Road, Pune Maharashtra
Pune
MAHARASHTRA 		 9822091220

agarwalclinic@gmail.com 
Dr Sreenivas Murthy  Lifecare Hospital and Research Centre  Lifecare Hospital and Research Centre #2748/2152 M L N Enclave 16 E Cross, 8th main, D Block, next to corporation Bank Sahakarnagar, Bangalore- 560092
Bangalore
KARNATAKA 		 9950509350

drlsm@lcrc.in 
Dr Arpandev Bhattacharyya  Manipal Hospital Bangalore  Manipal Hospital Bangalore,98,HAL,OAR Kodihalli, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017, India
Bangalore
KARNATAKA 		 9886051410

Arpan@DiabetesEndocrinology.in 
Dr Ambrish Mithal  Max Super Speciality Hospital   Max Super Speciality Hospital, (A unit of Devki Devi Foundation), 2, Press Enclave Road, Saket, New Delhi, 110017
New Delhi
DELHI 		 91-9811019093

ambrishmithal@hotmail.com 
Dr Sunil K Mishra  Medanta The Medicity, Gurgaon  Medanta The Medicity, sector 38- Gurgaon-Haryana 122001
Gurgaon
HARYANA 		 9899899954

docsunil09@yahoo.com 
Dr Girish P  Renai Medicity, Kochin  Renai Medicity, Palarivattom Edapally Road Near Palarivattom Metro Station Palarivattom P.O, Kochi, Kerala 682025, India
Ernakulam
KERALA 		 8872375221

girishparthan@gmail.com 
Dr Ganapti Bantwal  St. John Medical College and Hospital  St. John Medical College and Hospital, Sarjapur Main Road, Bangalore, Karnataka -560034
Bangalore
KARNATAKA 		 9448067318

mallyaganapathi@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee BSES MG Hospital  Approved 
Ethics Committee of Manipal Hospitals  Approved 
Human Welfare Ethical Committee for Human Sciences and Research  Approved 
Institute Ethics Committee AIIMS  Approved 
Institute Ethics Committee Poona Medical Research Foundation  Approved 
Institutional ethics committee St Johns Medical College and Hospital  Approved 
Life Care Hospital Institutional Review Board  Approved 
lnstitutional Ethics Committee Devki Devi Foundation  Approved 
Medanta Institutional Ethics Committee  Approved 
Medysis Clinisearch Ethical Review Board  Approved 
Prince Aly Khan Hospital Institutional Ethics Committee  Approved 
Renai Medicity Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Insulin glargine 100 units/mL  Insulin glargine 100 units/mL, subcutaneous, solution for injection, 3 mL SoloSTAR pre-filled pen-injector. 
Intervention  Insulin icodec 700 units/mL  Insulin icodec 700 units/mL, subcutaneous, solution for injection, 3 mL PDS290 pre-filled pen-injector  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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.
3. Age above or equal to 18 years at the time of signing informed consent.
4. Diagnosed with T2D ≥ 180 days prior to the day of screening.
5. HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by
central laboratory analysis.
6. Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec,
insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4
daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin
lispro, faster acting insulin lispro, insulin glulisine) ≥ 90 days prior to the day of screening
with or without any of the following anti-diabetic drugs/regimens with stable doses ≥ 90
days prior to screening:
• Metformin
• Sulfonylureas
• Meglitinides (glinides)
• DPP-4 inhibitors
• SGLT2 inhibitors
• Thiazolidinediones
• Alpha-glucosidase inhibitors
• Oral combination products (for the allowed individual oral anti-diabetic
drugs)
• Oral or injectable GLP-1 RAs
7. Body mass index (BMI) ≤ 40.0 kg/m2. 
 
ExclusionCriteria 
Details  Subjects are excluded from the trial if any of the following criteria apply:
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 an adequate contraceptive method (adequate contraceptive measures
as required by local regulation or practice).
4. Participation in any clinical trial of an approved or non-approved investigational medicinal
product within 90 days before screeninga. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with
insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus
regimen. This includes comparing the difference in change from baseline in HbA1c between insulin
icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.
VV- 		 Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point 
 
Secondary Outcome  
Outcome  TimePoints 
Change in fasting plasma glucose
(FPG)
From baseline week 0 (V2) to week 26 (V28) 		 From baseline week 0 (V2) to week 26 (V28) 
Number of severe hypoglycaemic
episodes (level 3)
From baseline week 0 (V2) to week 31 (V30) 		 From baseline week 0 (V2) to week 31 (V30) 
Time in target-range 3.9–10.0
mmol/L (70-180 mg/dL)
From week 22 (V24) to week 26 (V28) 		 From week 22 which is V24 to week 26 which is V28 
Number of clinically significant
hypoglycaemic episodes (level 2)
(3.0 mmol/L (54 mg/dL), confirmed
by BG meter) or severe
hypoglycaemic episodes (level 3) 		 From baseline week 0 (V2) to week 31 (V30) 
Number of clinically significant
hypoglycaemic episodes (level 2)
(3.0 mmol/L (54 mg/dL), confirmed
by BG meter) 		 From baseline week 0 (V2) to week 31 (V30) 
 
Target Sample Size   Total Sample Size="580"
Sample Size from India="125" 
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   Phase 3 
Date of First Enrollment (India)   15/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/05/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="23" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is a 26-week randomised, open label, active-controlled, parallel-group, multicentre, multinational, treat-to-target trial with two treatment arms investigating the effect on glycaemic control and safety of treatment with once weekly insulin icodec compared to once daily insulin glargine, both in combination with insulin aspart with or without non-insulin anti-diabetic drugs, in subjects with T2D.The trial duration is approximately 33 weeks, consisting of a 2-week screening period, followed by a 26-week randomised treatment period and a 5-week follow-up period.
 
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