CTRI/2025/10/095698 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On:
29/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Other (Specify) [Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Phase 3 Study]
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To Evaluate the Effectiveness and Safety of Oral Semaglutide Tablets of Sun Pharma Laboratories Limited in Comparison to Rybelsus (Semaglutide) Tablets in treatment of patients with Type 2 Diabetes Mellitus
Scientific Title of Study
A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral Semaglutide Tablets of Sun Pharma Laboratories Limited in Comparison to Rybelsus (Semaglutide) Tablets in Type 2 Diabetes Mellitus
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No. ICR/23/009; Version No. 3.0; Dated 04/AUG/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244324
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
Deputy General Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244324
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Digambar Tornale
Designation
Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA
400063
India
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244324
Email
Digambar.Tornale@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharma Laboratories Limited
SPARC, Tandalja, Vadodara - 390 012, Gujarat, India.
Room no – 4213,Department of Endocrinology, 2nd floor, Wing B, OPD Building, All india Institute of Medical Sciences Bathinda, mandi Dabwali Road, Jodhpur Romana, Bathinda, Punjab 151001, India Bathinda PUNJAB
9464739943
Shivani66sidana@gmail.com
Dr Ameya Sudhakar Joshi
Bhaktivedanta Hospital and Research Institute
3rd Floor, Medical Research Department, Bhaktivedanta Hospital and
Research Institute Srishti
Complex, Bhaktivedanta Swami Marg, Mira Road (East) Thane-
401107
Thane MAHARASHTRA
9320199122
feasibility@bhaktivedantahospital.com
Dr Unnikrishnan Ambika Gopalakrishnan
Chellaram Diabetes Institute
1st
Floor, Lalani Quantam, Pune-
Bangalore NH-4, Bavdhan (Budruk), Pune 411021, Maharashtra, India.
Pune MAHARASHTRA
9689287337
uagcdi@cdi.org.in
Dr Ambanna Gowda
Citizen Hospital
Dept of General Medicine ,Citizen Hospital, #14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore 560002 Bangalore KARNATAKA
9845270377
Dr.ambanagowda@gmail.com
Dr Richa Giri
G.S.V.M Medical College
Room No 1, Ground Floor, Postgraduate, Department of Medicine, G.S.V.M Medical College, Swaroop Nagar, Kanpur, 208002, U.P India Kanpur Nagar UTTAR PRADESH
8400331045
drrichagiri.gsvm@gmail.com
Dr Laddikam Suneel Kumar
Gandhi Hospital
Inpatient Block, 2nd Floor, Department of General Medicine, Gandhi Hospital, Musheerabad, Secundrabad, Telangana-500003 Hyderabad TELANGANA
9000976655
Drsuneelkumar73@gmail.com
Dr Aquil Kalanad
Government Medical College
Room no. 65, Department of general medicine, Government Medical College, Medical College Junction 17,
Mavoor Road, Near Police Station, Kozhikode
Kerala -673008, India
Kozhikode KERALA
9778425559
draquilkalanad2020@gmail.com
Dr Jangid Sanjay Kumar
Hi-Tech Medical College & Hospital
Dept of General Medicine, Ground floor, OPD Room no 1, Hi-Tech Medical College & Hospital, Pandra, Rasulgarh, Bhubaneswar, Khordha, Odisha-751025 Khordha ORISSA
9438009006
jangidsanjay88@rediffmail.com
Dr Amit Bhaskar
Janta Hospital & Maternity Centre
OPD No 01, Janta Hospital & Maternity Centre, Near Water head tank, Amara- Akhari Bypass, Chunar Road, Varanasi- 221011, Uttar Pradesh India Varanasi UTTAR PRADESH
9580210470
dramitbhaskarvns@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru Medical College
Room No 99, Ground Floor, OPD Building, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001, Rajasthan Ajmer RAJASTHAN
9460479888
doctorsanjiv@gmail.com
Dr Valluri Satya Prasad
King George Hospital
Department of General Medicine, King George Hospital, Andhra Pradesh, Medical college Maharanipeta Visakhapatnam 530002, Andhra Pradesh India Visakhapatnam ANDHRA PRADESH
9393104578
Drvsatyaprasadresearch@gmail.com
Dr Rekha MC
Mandya Institute of Medical Science
NO 14, Dept of General Medicine, Mandya Institute of Medical Science, Mysore – Bangalore Highway, Mandya, Karnataka-571401 Mandya KARNATAKA
9845343736
drrekhamc73@gmail.com
Dr Ambrish C
Medstar Speciality Hospital,
Department of Endocrinology Medstar Speciality Hospital, 641/17/1/3, Kodigehalli Main Road, Sahakar nagar, Bangalore-560092, Karnataka, India Bangalore KARNATAKA
9845895911
drambrishmedstar@gmail.com
Dr Yash Arun Bahulikar
MMFHA Joshi Hospital,
Department of Endocrinology, MMFHA Joshi Hospital, 778, Shivajinagar Opp. Kamala Nehru park, Pune-411004, Maharashtra, India. Pune MAHARASHTRA
020-41096666
dr.yashbahulikar0308@gmail.com
Dr Jitendra Shukla
Motilal Nehru Medical College
Department of Medicine, Room No 1, Motilal Nehru Medical College,
George Town Civil Lines,
Prayagraj UP 211002
Allahabad UTTAR PRADESH
8527483333
drjitendramln@gmail.com
Dr Rama Walia
Nehru Hospital Extension
Department of Endocrinology, Nehru Hospital Extension, Post Graduate institute of medical education and research, Chandigarh-160012 Chandigarh CHANDIGARH
9872997438
ramawalia@rediffmail.com
Dr Arjun Baidya
Nil Ratan Sircar Medical college & Hospital
Department of Endocrinology, Nil Ratan Sircar Medical college & Hospital, 138 AJC Bose Road, Kolkata- 700014, West Bengal, India Kolkata WEST BENGAL
9433154618
Arjun.baidya@gmail.com
Dr Biplab Mandal
North Bengal Medical college & Hospital
Department of General Medicine, North Bengal Medical college & Hospital, Sushrutangar, Siliguri, West Bengal, 734012 Darjiling WEST BENGAL
9434255271
drbiplabmandal@gmail.com
Dr Niranjan Pandurang Pathak
Ojas Multispeciality Hospital
OPD No 1, Ground Floor, Ojas Multispeciality Hospital, Sr no 203/1, D.Y Patil College Road, Ravet, Pune-412101 Pune MAHARASHTRA
9730490292
nrnjnpats@gmail.com
Dr K Neelaveni
Osmania General Hospital
Department of Endocrinology, 2nd floor, Golden Jubilee Block, Osmania General Hospital, Afzalgunj, Hyderabad- 500012, Telangana India Hyderabad TELANGANA
9848121182
neelaveni1@yahoo.co.in
Dr Aditya Shrirang Bari
Pulse Multispeciality Hospital
Pulse Multispeciality Hospital, Sr no 51/7/B/1, first floor, Vishwa Arcade Opp. Deccan Pavilion
Hotel, Mumbai-Bangalore Highway Narhe, Pune-411041
Pune MAHARASHTRA
9970126406
dradityabari01@gmail.com
Dr Mani Deepathi Dasari
Rajalakshmi Hospital & Research Center
Room no 2, Rajalakshmi Hospital & Research Center
#21/1 Laskhmipura Main Road Vidyaranyapura Post Bangalore-560097
Bangalore KARNATAKA
9738877298
manideepthi36@gmail.com
Dr Uday Keshav Phadke
Sahyadri Super Speciality
Hospital Deccan Gymkhana, Plot no 30 C,1st Floor Room no 9 Erandwane, Karve Road. Pune 411004, Maharashtra, India Pune MAHARASHTRA
9822025180
uday@drudayphadke.com
Dr Bharat Das
Sparsh Hospitals and Critical Care Private Limited
Ground floor, OPD Room no 1 , Dept of General Medicine Sparsh Hospitals and Critical Care Private Limited Plot No-A/407, Saheed Nagar, Bhubaneswar Khordha, Orissa - 751007 India Khordha ORISSA
9938190845
Bharatdas.74@gmail.com
Dr Shweta Bhandari
Vincare Hospital
OPD-3, Ground Floor, Vincare Hospital, 100 feet road,
Opp. Petrol Pump, Bathinda,
Punjab-151001, India
Bathinda PUNJAB
Week 0 (Day 0): Initial dose of 3 mg (Once daily for 4 weeks)
Week 4 (Day 28 ± 3): Uptitration to the dosage of 7 mg (Once daily for 4 weeks)
Week 8 to Week 20: Uptitrate to or maintain at 14 mg as per FBG, PPBG or HbA1c level
Intervention
Semaglutide Tablets 3 mg, 7 mg, 14 mg (Manufactured by Sun Pharma Laboratories
Limited)
Week 0 (Day 0): Initial dose of 3 mg (Once daily for 4 weeks), Week 4
(Day 28 ± 3): Uptitration to the dosage of 7 mg (Once daily for 4 weeks), Week 8 to Week 20: Uptitrate to or maintain at 14 mg, as per FBG,PPBG or HbA1c level
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either sex, aged 18 to 65 years (both inclusive) and who are willing to give written informed consent to participate in the study.
2. Patients with diagnosis of T2DM with glycated haemoglobin (HbA1c) more than equal to7.0% and less than equal to 10.5%.
3. Patients along with diet and exercise control, on stable daily dose of metformin (more than equal to 1500 mg or maximum tolerated dose based on clinical record) for at least 12 weeks prior to the day of screening.
4. Women of childbearing potential must have a negative urine pregnancy test at study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (
5. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period.
ExclusionCriteria
Details
1. Patients with history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or any of the excipients of the study drugs.
2. Patients with Fasting Blood Glucose (FBG) more than equal to 270 mg/dL at screening.
3. Treatment with any medication for diabetes or obesity within 90 days before screening (other than metformin, or short-term insulin [less than equal to14 days in total].
4. Patients with myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack within the past 180 days; history of or planned coronary, carotid or peripheral artery revascularization known on the day of screening.
5. Patients presently classified as being in New York Heart Association (NYHA) Class and III or IV heart failure.
6. Patients having significant renal or hepatic impairment (
7. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas).
8. Patients with proliferative/ unstable retinopathy and maculopathy
9. Patients with history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
10. Patients diagnosed with type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing syndrome or acromegaly- associated diabetes).
11. Any condition (e.g., infection, trauma and surgery) which require insulin therapy (other than short term insulin therapy) at the time of screening or during the study period.
12. Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
13. Pre-planned surgery or medical procedure that would interfere with the conduct of the study
14. Patients with known alcohol or other substance abuse within last one year.
15. Pregnant, lactating women or women who intend to conceive or women of childbearing age who are not willing to use an acceptable method of birth control during the study period
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Change from baseline in HbA1c
Baseline, Week 24
Secondary Outcome
Outcome
TimePoints
Change from baseline in HbA1c
Baseline, Weeks 12, 16 and 20
Change from baseline in FBG
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change from baseline in Postprandial Blood Glucose (PPBG)
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change from baseline in body weight and BMI
Baseline, Week 24
Change from baseline in fasting lipid profile parameters [total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL)cholesterol, very low-density lipoprotein (VLDL) cholesterol, Triglyceride (TG)]
Baseline, Week 24
Proportion of patients achieving HbA1c less than 7.0%
Weeks 12, 16, 20 and 24
Proportion of patients receiving rescue medications
Throughout the study period
Incidence of TEAEs and SAEs
Throughout the study period
Proportion of patients requiring hypoglycaemia management
Throughout the study period
Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (NAb)
Baseline [Day 0, Pre-dose], Week 24
Target Sample Size
Total Sample Size="314" Sample Size from India="314" 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)
17/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="10" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
This will be a prospective, multicenter, randomized, double-blind, double-dummy, active-controlled, Phase 3 Study. The study will be conducted at approximately 20-30 centres from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee approval. The study will randomize approximately 314 patients.
During screening period, after obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments.
After confirming eligibility, patients will be randomized in 1:1 ratio to either Test arm or Comparator arm
The efficacy and safety will be assessed during the study period as mentioned in Schedule of Assessment