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CTRI Number  CTRI/2024/05/067886 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes 
Scientific Title of Study   A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
137406  Other 
2023-506084-34  EudraCT 
U1111-1292-6151  UTN 
Version 2.0 dated 02 April 2024  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  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Limited Nxt Tower 2 Floor 1 & 2 Embassy Manyata Business Park Nagavara Village Kasaba Hobli Bangalore 560045_India

Bangalore
KARNATAKA
560045
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Limited Nxt Tower 2 Floor 1 & 2 Embassy Manyata Business Park Nagavara Village Kasaba Hobli Bangalore 560045_India


KARNATAKA
560045
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
Novo Nordisk A/S-Novo Alle, 2880 Bagsvaerd Denmark 
 
Primary Sponsor  
Name  Novo Nordisk India Private Limited 
Address  Novo Nordisk India Private Limited,Nxt Tower 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore 560045. India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bulgaria
Germany
India
Japan
Poland
South Africa
Spain
United States of America  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeta Deshpande  Belgaum Diabetes Centre  Maruti Street Pincode: 590001
Belgaum
KARNATAKA 		 9880271313

neetarohit@gmail.com 
Dr Unnikrishnan Ambika Gopalakrishnan   Chellaram Diabetes Institute  1st floor, Lalani- quantum, Pune-Bangalore NH 4 Bavdhan Budruk, Pune -411021, Maharashtra India
Pune
MAHARASHTRA 		 9689287337

uagcdi@cdi.org.in 
Dr Jubbin Jagan Jacob  Christian Medical College And Hospital   Endocrine and Diabetes Unit Department of Medicine, Brown road Pin code: 141008
Ludhiana
PUNJAB 		 7696765088

jubbin.jacob@gmail.com 
Dr Vijay Sheker Reddy D  Gandhi Hospital   Department of Endocrinology 3rd floor Main Building Pincode: 500003
Hyderabad
TELANGANA 		 9849172161

drdvsreddyendo@yahoo.com 
Dr Saurabh Srivastava  Government Institute of Medical Sciences  Department of medicine near Gautam Buddha University Delhi NCR Kasna Village Greater Pincode: 201310
Gautam Buddha Nagar
UTTAR PRADESH 		 9654233158

saurabhsrivas@gmail.com 
Dr Sanjay Agarwal  Grant Medical Foundation Ruby Hall Clinic   40 Sassoon Road Pincode: 411001
Pune
MAHARASHTRA 		 8007885133

sanjayagarwal.trials@gmail.com 
Dr Anurag Ranjan Lila  GS Medical College and KEM Hospital   Endocrinology Department, OPD 103 First Floor OPD Building Acharya Donde Marg Parel Pincode: 400012
Mumbai
MAHARASHTRA 		 9323065346

anuraglila@gmail.com 
Dr Sadishkumar Kamalanathan  JIPMER   Dept of Endocrinology GORIMEDU DHANVANTRI NAGAR Pincode:605006
Pondicherry
PONDICHERRY 		 9629528518

sadishkk@gmail.com 
Dr Sreenivasa Murthy L  Lifecare hospital and research centre   First Floor 2748 or 2152 M L N ENCLAVE 16th E Cross 8th Main D Block Next to Corporation Bank SAHAKARNAGAR Pincode: 560092
Bangalore
KARNATAKA 		 9448051046

drlsm@lcrc.in 
Dr Leelabati Toppo  Malla Reddy Narayana Multispecialty Hospital  Suraram X road Jeedimetla Qutbullapur Pincode:500055
Hyderabad
TELANGANA 		 8886436633

leelabati.rath@gmail.com 
Dr Arpandev Bhattacharyya  Manipal Hospital   No 98 HAL Airport Road Pincode: 560017
Bangalore
KARNATAKA 		 9886051410

arpan@diabetesendocrinology.in 
Dr Sanjay kumar Bhadada  Post Graduate Institute of Medical Education and Research   Department of Endocrinology Room no 04 Nehru Hospital Extension Block Sector 12 Pincode: 160012
Chandigarh
CHANDIGARH 		 9876602448

dr.bhadada@gamil.com 
Dr Sunil M Jain  TOTALL Diabetes Hormone Institute  A unit of Diabetes Thyroid Hormone Research Institute Pvt Ltd BCM Health Island PU4 Scheme 54 Near Bombay Hospital Behind Prestige Institute of Management Indore 452010 Madhya Pradesh India
Indore
MADHYA PRADESH 		 9826023182

sunilmjain@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Chellaram Diabetes Institute Institutional Ethics Committee  Approved 
Ethics Committee Manipal Hospitals  Approved 
Ethics Committee of Diabetes Thyroid Hormone Research Institute  Approved 
GIMS Institutional Ethics Committee  Approved 
IEC Intervention Studies JIPMER  Approved 
Institutional Ethics Committee  Not Applicable 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Not Applicable 
Institutional Ethics Committee  Not Applicable 
Institutional Ethics committee Poona Medical Research Foundation  Approved 
Institutional Ethics Committee-l  Approved 
Lakeview Ethics Committee  Approved 
Life Care Hospital Institutional Review Board  Approved 
MRMCW- Institutional Ethics Committee   Not Applicable 
 
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  Dose: once-daily insulin glargine U100 Frequency route of administration: Subcutaneous (into the thigh, upperarm or abdomen). Once daily dosing for a total of 26 weeks during intervention period. Manufactured by Sanofi A S and Supplied by Novo Nordisk A S Total Duration of such intervention: 26-week 
Intervention  Insulin icodec  Dose: Insulin icodec is formulated as a 4200 nmol/mL solution equivalent to 700 U/mL and filled in 3 mL cartridges Frequency route of administration: Icodec IMP, test product Subcutaneous (into the thigh, upperarm or abdomen). Once weekly dosing for a total of 26 weeks during intervention period. Manufactured and supplied by Novo Nordisk A S Total Duration of such intervention: 26-week  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Diagnosed with T2D for more than or equal to 180 days prior to the day of screening.2 HbA1c from 7.0 to 10.0 percent (53.0 to 85.8 mmol per mol), both inclusive, at screening confirmed by central laboratory analysis.3 Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin,insulin degludec, insulin detemir, insulin glargine 100 U per mL, or insulin glargine 300 U per mL) more than or equal to 90 days prior to the day of screening with or without any of the following anti diabetic drugs or re-gimens with stable doses more than or equal to 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), DPP 4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti diabetic drugs), oral or injectable GLP 1 RAs, injectable GLP 1 or GIP RA combination products.4 Body mass index (BMI) less than 40.0 kg per m2. 
 
ExclusionCriteria 
Details  1. Known or suspected hypersensitivity to study intervention(s) or related products.
2. Previous participation in this study. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4). 4. Participation (i.e., signed informed consent) in any interventional clinical study within 90 daysbefore screening. Note: Simultaneous participation in a study with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening in the current study.
5. Any disorder, except for conditions associated with T2D, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
6. Any episodesa of diabetic ketoacidosis within 90 days prior to the day of screening.
7. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
8. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
9. Planned coronary, carotid or peripheral artery revascularisation.
10. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m2 at screening by central laboratory analysis.
11. Impaired liver function, defined as Alanine Aminotransferase ≥ 2.5 times or Bilirubin >1.5 times upper normal limit at screening.
12. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8 (Section 8.2).
13. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
14. Inadequately treated blood pressure defined as systolic ≥180 mmHg or diastolic ≥110 mmHg at screening.
15. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days prior to the day of screening.
16. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
17. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening (V1) and until the start of runin (V2). Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
18. Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia [PIN]) within 5 years before screening. 19. Anticipated change in lifestyle affecting glucose control (e.g., eating, exercise or sleeping pattern) during the study.
20. Use of any medication with unknown or unspecified content within 90 days prior to the day of Screening. 
 
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,
switched unit-to-unit from a daily basal
insulin, with or without non-insulin antidiabetic
drugs, in participants with T2D
treated with basal insulin. This includes
comparing the difference in change from
baseline in HbA1c between insulin icodec
and insulin glargine U100 after 26 weeks of
treatment to a non-inferiority margin of
0.3%-point - Change in HbA1c 		 From baseline week 0
(V6) to week 26 (V32) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare parameters of glycaemic control, patient reported outcomes and safety of once weekly insulin icodec, switched unit to unit from a daily basal insulin, compared to once daily insulin glargine U100, both treatment arms with or without non insulin anti diabetic drugs, in participants with T2D treated with basal insulin.

Secondary efficacy endpoints
1. Change in time in range 3.9 to 10.0 mmol per L (70 to 180 mg per dL)

2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
 




1. From baseline week minus 4 to 0 (V2 to V6) to week 22 to 26 (V28 to V32)

2. From baseline week 0 (V6) to week 26 (V32)
 
Secondary safety endpoints

1. Number of severe hypoglycaemic episodes (level 3)
2. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol per L (54 mg per dL), confirmed by BG meter)
3. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol per L (54 mg per dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
4. Time spent less than 3.0 mmol per L (54 mg per dL)
5. Change in time spent more than 10.0 mmol per L (180 mg per dL)
6. Mean weekly insulin dose
7. Change in body weight
 

1. From baseline week 0 (V6) to week 31 (V34)
2. From baseline week 0 (V6) to week 31 (V34)
3. From baseline week 0 (V6) to week 31 (V34)
4. During week 22 to 26 (V28 to V32)
5. From baseline week minus 4 to 0 (V2 to V6) to week 22 to 26 (V28 to V32)
6. From week 24 (V30) to week 26 (V32)
7. From baseline week 0 (V6) to week 26 (V32)
 
Exploratory endpoints
Change in TRIM D (Treatment
Related Impact Measure for
Diabetes) total 		 From baseline week 0 (V6) to week 26 (V32) 
 
Target Sample Size   Total Sample Size="404"
Sample Size from India="80" 
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)   20/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="8"
Days="6" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
This is an interventional, multi-national, multi-centre, randomised, parallel-group, treat-to-target, open-label, active-comparator study.

This is a 26-week study designed to investigate the effect on glycaemic control, safety and patient reported outcomes (PROs) of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, versus once-daily insulin glargine U100, both treatment arms with or without non-insulin anti-diabetic drugs, in adults with type 2 diabetes (T2D) treated with basal insulin.


 
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