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CTRI Number  CTRI/2019/06/019817 [Registered on: 21/06/2019] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A research study to look at how semaglutide compared to placebo affects diabetic eye disease in people with type 2 diabetes (FOCUS) 
Scientific Title of Study   Long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes (FOCUS) 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2023-506827-26  EudraCT 
NCT03811561  ClinicalTrials.gov 
NN9535-4352, Version 6.0 Dated 29 July 2022  Protocol Number 
U1111-1201-6256  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
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
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  8040303200  
Fax  08041123518  
Email  VJYP@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
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  8040303200  
Fax  08041123518  
Email  VJYP@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk A/S-Novo Allé, 2880 Bagsvaerd Denmark. 
 
Primary Sponsor
Modification(s)  
Name  Novo Nordisk  
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
Modification(s)  
Name  Address 
Nil  Nil 
 
Countries of Recruitment
Modification(s)  		   Latvia
Brazil
Bulgaria
Canada
Czech Republic
Germany
India
Israel
Mexico
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
Spain
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhil Tandon  All India Institutes of Medical Sciences  Seminar Room, AB 6 Ward, 6th Floor, Ward Block Ansari Nagar New Delhi Delhi 110029
New Delhi
DELHI 		 9818211663

nikhil_tandon@hotmail.com 
Dr Harish Kumar  Amrita Institute of Medical Sciences  Department of Endocrinology, Healthcare Education and Research, AIMS- Ponekkara Kochi Kerala 682041
Ernakulam
KERALA 		 9895545190

harishkumar@aims.amrita.edu 
Dr Tirthankar Chaudhury  Apollo Gleneagles Hospitals  Department of Clinical Trials & Research, Apollo Gleneagles Hospitals, 58, Canal Circular Road, Kolkata-700054
Kolkata
WEST BENGAL 		 9831322394

tchaudhury67@yahoo.co.uk 
Dr Arthur Joseph Asirvatham   Arthur Asirvatham Hospital  Department of Endocrinology ,A- Kuruvikaran Salai Anna Bus Stand Madurai Tami Nadu 625020
Madurai
TAMIL NADU 		 9443751977

ajasirvathamresearch@yahoo.in 
Dr Bipin Kumar Sethi  Care Out Patient Centre  Department of Endocrinology, 8-2-620/A-E, Road No.10 Banjara Hills Hyderabad Andra Pradesh 500 034
Hyderabad
TELANGANA 		 9848021482

sethibipin54@gmail.com 
Dr Jubin Jagan Jacob  Christian Medical College and Hospital  Department of Endocrinology Clinical Trial Unit/Endocrine and Diabetes Unit, Department of Medicine Ludhiana Punjab 141008
Ludhiana
PUNJAB 		 9915281219

jubbin.jacob@gmail.com 
Dr Vaishali Deshmukh  Deenanath Mangeshkar Hospital and Research Centre  SS Building Ground Floor, Endocrinology Department, Erandwane Pune Maharastra 411004
Pune
MAHARASHTRA 		 9850811450

drvaishaliresearch@gmail.com 
Dr Aravind R Sosale  Diacon Hospital Pvt Ltd  #360, 19th Main, 1st Block, Rajajinagar, Bangalore- 560010, India
Bangalore
KARNATAKA 		 8023130577

draravindsr.pi@gmail.com 
Dr Kongara Srikanth  Endolife Hospital  1st floor, Clinical Research Department, Endolife Hospital, Old Club Rd, Kothapeta, Guntur, Andhra Pradesh 522001, India
Guntur
ANDHRA PRADESH 		 9849945577

srikanthendo@gmail.com 
Dr Chandrasekhar Atkar  Government Medical College and Hospital  Medical Research Room, 2nd floor, beside ward no 48, Government Medical College and Hospital, Medical College Square Road, Nagpur-440003, Maharashtra, India
Nagpur
MAHARASHTRA 		 9579404986

cmatkar92@gmail.com 
Dr Jabbar Puthiya Veettil Khader  Indian Institute of Diabetes  Indian Institute of Diabetes, Pulayanarkotta, Thiruvananthapuram-695031, Kerala
Thiruvananthapuram
KERALA 		 9446828766

drjabbar10@gmail.com 
Dr S K Wangnoo  Indraprastha Apollo Hospital  Apollo Hospital, Chennai - Room No 4169,1st Floor, Delhi Highway, Mathura Rd, Saritha Vihar, New Delhi-110076
New Delhi
DELHI 		 9810113922

subhashwang@hotmail.com 
Dr V Mohan  Madras Diabetes Research Foundation  Department of Endocrinology,No.4, Conran Smith Road Gopalapuram Chennai Tami Nadu 600086
Chennai
TAMIL NADU 		 04443968888

drmohans@diabetes.ind.in 
Dr Subramanian Kannan  Mazumdar Shaw Medical Centre  Department of Endocrinology, Consultant Endocrinologist, Mazumdar Shaw Medical Centre, Unit of Narayana Hrudayalaya Limited, 258/A, Bommasandra Industrial Area, Anekal TK Bangalore-560099
Bangalore
KARNATAKA 		 8095084568

subramanian.kannan@gmail.com 
Dr Nikhil M Bhagwat  T. N . Medical College and B Y L Nair Charitable Hospital  Department of Endocrinology, Room no 419, 4th Floor College Building, , Dr. A L Nair Hospital, Mumbai Central, Mumbai Maharastra 400 008
Mumbai
MAHARASHTRA 		 9820238399

bhagwatnik@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Diacon Hospital Ethics Committee  Approved 
Institutional Ethics Committee Indian Institute of Diabetes   Approved 
Institutional Ethics Committee of Endolife Specialty Hospitals Pvt Ltd  Approved 
Institutional Ethics Committee of Madras Diabetes Research Foundation  Approved 
Institutional Ethics Committee, Christian Medical College and Hospital  Approved 
Institutional Ethics Committee, AIIMS  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences & Research Centre  Approved 
Institutional Ethics Committee, Apollo Gleneagles   Approved 
Institutional Ethics Committee, Arthur Asirvatham Hospital  Approved 
Institutional Ethics Committee, CARE Foundation  Approved 
Institutional Ethics Committee, Clinical studies, Indraprastha Apollo Hospitals  Approved 
Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre  Approved 
Institutional Ethics Committee, Government Medical College & Hospital  Approved 
Institutional Ethics Committee,T. N . Medical College and B Y L Nair Charitable Hospital  Approved 
Narayana Health Medical 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  Placebo   Dose: Subjects will be initiated at a once-weekly dose of 0.25 mg s.c. and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 mg/week), to improve glycemic control as judged by the investigator Duration: Trial duration for each subject will be five years (260 weeks) plus the follow-up period which is five weeks after end-of-treatment.  
Intervention  Semaglutide   Dose: Subjects will be initiated at a once-weekly dose of 0.25 mg s.c. and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 mg/week), to improve glycemic control as judged by the investigator Duration: Trial duration for each subject will be five years (260 weeks) plus the follow-up period which is five weeks after end-of-treatment.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Diagnosed with type 2 diabetes mellitus. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).2. Eye inclusion criteria (both eyes must meet all criteria):3. Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre 4. No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.5. No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation. 6.Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol 7. No previous treatment with pan-retinal laser photocoagulation 8. No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial 9.No substantial media opacities that would preclude successful imaging. 
 
ExclusionCriteria 
Details  Subjects are excluded from the trial if any of the following criteria apply:
1. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening.
2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
3. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
4. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of
eGFR less than 30 ml per min per 1.73 m2.
5. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
6. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
8. Current or previous (within 30 days before screening) treatment with any GLP-1 receptor agonist or DPP-4 inhibitor.
9. Receipt of any investigational medicinal product within 30 days before screening.
10. Previous participation in this trial. Participation is defined as randomisation.
11. Known or suspected hypersensitivity to trial products or related products.
12. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
Based on medical history using latest available and no more than 6 months old assessment. If not available in medical records a local laboratory measurement must be made available before randomisation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint is presence of more than or equal to 3 steps ETDRS (Early Treatment Diabetic Retinopathy
Study) subject level progression at year 5.  		 5 Years  
 
Secondary Outcome  
Outcome  TimePoints 
Confirmatory Secondary Endpoints/Outcomes-Time from randomisation to first more than or equal to 3 steps ETDRS subject level progression or ciDME in either eye
(month).
 		 5 Years  
Supportive secondary outcome/Change from baseline at year 5 in:
· Visual acuity in the worse seeing eye (number of letters)
· Visual acuity in the better seeing eye (number of letters)
 		 5 Years  
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye during the period from randomisation to year 5 with:
· Focal/grid laser photocoagulation (yes/no)
· Pan-retinal laser photocoagulation (yes/no)
· Intravitreal injection with anti-VEGF (yes/no)
· Intravitreal injection with steroid (yes/no)
· Vitrectomy (yes/no)
 		 5 Years  
Presence of:
· more than or equal to 3 ETDRS subject level improvement at year 5 (yes/no)
· more than or equal to 2 steps ETDRS subject level progression at year 5 (yes/no)
· more than or equal to 2 steps ETDRS subject level improvement at year 5 (yes/no)
 		 5 Years  
Persistent visual acuity less than or equal to 38 ETDRS letters in either eye at year 5 (yes/no)
· Persistent more than or equal to 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline at
year 5 (yes/no)
· Persistent more than or equal to 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline at
year 5 (yes/no)
 		 5 Years  
Persistent more than or equal to 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline
at year 5 (yes/no)
· Persistent more than or equal to 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline
at year 5 (yes/no
 		 5 Years  
· ciDME in either eye at year 5 (yes/no)
Change from baseline at year 5 in:
· HbA1c (%-point)
· Body weight (kg)
· Systolic and diastolic blood pressure (mmHg)
· Lipids: Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/L)
 		 5 Years  
 
Target Sample Size
Modification(s)  		 Total Sample Size="1467"
Sample Size from India="218" 
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)   24/06/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/05/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  		 Years="8"
Months="5"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This trial is a 5 year long randomised, double-masked, parallel-group, placebo-controlled trial comparing the effects of semaglutide versus placebo both administered subcutaneously once-weekly and added to standard-of-care in subjects with inadequately controlled T2D. Subjects will be randomised 1:1 to
receive either semaglutide or placebo and stratified based on diabetic retinopathy severity at baseline.
 
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