CTRI/2025/06/089290 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On:
04/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
This is a study to establish non-inferiority of Intas semaglutide subcutaneous injection
against Innovator semaglutide (Ozempic, Novo Nordisk) subcutaneous injection in adult
participants with type 2 diabetes mellitus who are inadequately controlled on metformin, in adjunct
to diet and exercise
Scientific Title of Study
A Prospective, Phase 3, Randomized, Interventional, Open-label,
Parallel-Group, Multicentre, Active Controlled Study to Establish Noninferiority
of Intas Semaglutide Subcutaneous Injection Against Innovator
Semaglutide (Ozempic, Novo Nordisk) Subcutaneous Injection in Adult
Participants With Type 2 Diabetes Mellitus Who Are Inadequately Controlled
on Metformin, in Adjunct to Diet and Exercise
Department of Clinical research, Room No. NA, Department of Medicine, B. J. Medical College and Civil Hospital, Asarwa, Ahmedabad 380016, Gujarat, india
Ahmadabad GUJARAT
992464379
drkartik@gmail.com
Dr Atul Jani
Bhailal Amin General Hospital
Department of Clinical research, Room No. NA, Bhailal Amin General Hospital, Gorwa, Vadodara
Vadodara GUJARAT
9825035925
dratuljani60@yahoo.com
Dr Manas Ghosh
COLLEGE OF MEDICINE & JNM HOSPITAL
Department of Clinical research, Room No. NA, A Block, Kalyani, Nadia, West Bengal, Pin 741235
Nadia WEST BENGAL
9007338202
dr.manas.ghosh@gmail.com
Dr Rajesh Khadgawat
Department of Endocrinology, AIIMS
Department of Clinical research, Room No. NA, All India Institute of Medical Sciences, Ansari Nagar
New Delhi 110029
New Delhi DELHI
9891418190
rajeshkhadgawat@hotmail.com
Dr Anurag Ranjan Kundan Lal Lila
Department of Endocrinology, Seth GS Medical College and KEM Hospital
Department of Clinical research, Room No. NA, OPD 103, First Floor, OPD building, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-400012
Mumbai MAHARASHTRA
9323065346
dranuraglila@gmail.com
Dr Sanjay Saran
Department of Endocrinology, SMS Medical College
Department of Clinical research, Room No. NA, SMS Medical College & Attached Hospitals, JLN March, Jaipur, Rajasthan, India-302004
Jaipur RAJASTHAN
9760190799
drsanjaysaran@gmail.com
Dr Archit Parikh
DHS Hospital
Department of Clinical research, Room No. NA, DHS Multispecialty Hospital, 18 Sunrise Park society Vastrapur Lake- Drive in Link Road, Gurukul, Ahmedabad, Gujarat 380054
Ahmadabad GUJARAT
9265121085
parikharchit@yahoo.com
DrSanjay Mehendiratta
Diabetes Bhawan and multispecialty hospital
Department of Clinical research, Room No. NA, D-52-53, Ramanagar, Gali no-4, Housing Board RD, Shastri Nagar, Jaipur 302016, Rajasthan
Jaipur RAJASTHAN
9829066516
drsmehendi@gmail.com
Dr Sujit Chandrartey
Endocare Clinic
Department of Clinical research, Room No. NA, Mohiniraj, Ghaghanpur Road, Nasik 422013, Maharashtra
Nashik MAHARASHTRA
9422758018
sujitchandratreya@gmail.com
Dr Kongara Srikanth
Endoliofe Speciality Hospitals
Department of Clinical research, Room No. NA, D.No: 12-12-94, Old Club Road, Kothapet, Guntur, Andhra Pradesh-522001, India
Guntur ANDHRA PRADESH
9849945577
srikanthendo@gmail.com
Dr Richa Giri
G.S.V.M. Medical College
Department of Clinical research, Room No. NA, Swaroop Nagar, Kanpur 208002, Uttar Pradesh, India
Kanpur Nagar UTTAR PRADESH
9839087069
krricha227@gmail.com
Dr Parag Shah
Gujarat Endocrine Centre
Department of Clinical research, Room No. NA, AWS 3, 518-526, Drive In Rd, opp. Manav Mandir Road, near helmet circle, Sushil Nagar Society, Memnagar, Ahmedabad, Gujarat 380052 Ahmadabad GUJARAT
9824042688
paragendo@gmail.com
Dr Vipul Gupta
Gupta Ultrasound & Heart care centre
Department of Clinical research, Room No. NA, A-4/22, Paschim vihar, New Delhi 110063
New Delhi DELHI
9953702661
guptavipul@hotmail.com
Dr Manoj Vithalani
HCG Hospitals
Department of Clinical research, Room No. NA, 1, Maharashtra Society, Near Mithakhali Six Roads, Ellisbridge, Ahmedabad-380006
Ahmadabad GUJARAT
9825024355
drmvithalani@gmail.com
Dr Nilesh Jagdale
Indrayani Hospital & Cancer Institute
Department of Clinical research, Room No. NA, Alandi Chakan Road, Alandi Devachi, Tal.Khed, Pune 412105
Pune MAHARASHTRA
7887884983
dr.nilesh.jagdale@gmail.com
Dr Sujoy Ghosh
IPGME&R and SSKM Hospital
Department of Clinical research, Room No. NA, 244 AJC Bose road, Kolkata -700020, West Bengal, India.
Kolkata WEST BENGAL
9674625823
drsujoyghosh2000@gmail.com
Dr Summaiya Anjum
K R Hospital
Department of Clinical research, Room No. NA, Department of Medicine, K R Hospital attached to Mysore Medical College and Research Institute, Irwin Road, Mysore 570001, Karnataka, India
Mysore KARNATAKA
7760218464
dr.sumaiyaanjum@gmail.com
Dr Sambit das
KIMS Hospital
Department of Clinical
research, Room No.
NA, Kalinga Institute of Medical Sciences Kushbhadra camous, 5, KIIT Roads, Bhubaneshwar, Odisha 751024
Khordha ORISSA
8093060177
drsambitendocrine@gmail.com
Dr Aruna Mangipudi
King George Hospital
Department of Clinical research, Room No. NA, Department of Endocrinology, King George Hospital, Maharanipeta, Visakhapatnam, Andhra Pradesh- 530002.
Visakhapatnam ANDHRA PRADESH
9440105711
drarunamangipudiresearch@gmail.com
Dr Shailesh Jethwa
Kiran Multi Super Speciality Hospital
Department of Clinical research, Room No. NA, Kiran Multi Super Speciality Hospital & Research Center, Vasta Devdi Road, Near Sumul Dairy, Surat - 395004
Surat GUJARAT
9879397811
drshaileshcjethwa@outlook.com
Dr R Balamurugan
Kovai Diabetes Specialty Centre and Hospital
Department of Clinical research, Room No. NA, No. 15, Vivekananda Road, Ramnaga, Coimbatore-641009
Coimbatore TAMIL NADU
9842244881
rbmkdsc@gmail.com
Dr L Srinivas Murthy
LIFECARE HOSPITAL AND RESEARCH CENTRE
Department of Clinical research, Room No. NA, 2748/2152, M.L.N COMPLEX , 16TH E CROSS, 8TH MAIN ROAD, D BLOCK NEXT TO UNION BANK OF INDIA , SAHAKARNAGAR, BENGALURU KARANATAKA 560092
Bangalore KARNATAKA
9448051046
drsreenivasamurthy@gmail.com
Dr Sandeep Kumar Gupta
M. V Hospital & Research Centre
Department of Clinical research, Room No. NA, 314/30, Mirza Mandi Chowk, Lucknow-226003
Lucknow UTTAR PRADESH
9336077839
sandeepkumar.gupta@rediffmail.com
Dr Ambrish C
Medstar Speciality Hospital
Department of Clinical research, Room No. NA, 641/17/1/3, Kodigehalli Main Road, Sahakar Nagar, Bangalore-560092, Karnataka, India
Bangalore KARNATAKA
9845895911
drambrishmedstar@gmail.com
Dr Chimu Chopde
New Mangal Murti Hospital
Department of Clinical research, Room No. NA, Plot no. 09, Ganeshwadi, Near Pande Dairy Chowk, Jalgoan-425001, Maharashtra, India.
Jalgaon MAHARASHTRA
9975163030
drchimu119@gmail.com
Dr Madhusudan C
NRR Hospital
Department of Clinical research, Room No. NA, 3 & 3A, Hesaraghatta Main Road, Chikkasandra, Near Chikkabanavara, Railway Station, Bengaluru, Karnataka 560090
Bangalore KARNATAKA
7022274227
drmadhusudanmadhu123@gmail.com
Dr Rakesh Kumar Sahay
OSMANIA MEDICAL COLLEGE AND HOSPITAL
Department of Clinical research, Room No. NA, Department of Endocrinology, 2nd floor, Golden Jubilee Block, Osmania Medical College & Osmania General Hospital, 15-5-104 BEGUM BAZAR AFZAL GUNJ HYDERABAD TELANGANA 500012
Hyderabad TELANGANA
9849597507
sahayrk@gmail.com
Dr Sanjaykumar Bhadada
Postgraduate Institute of Medical Education & Research
Department of Clinical research, Room No. NA, Nehru Hospital, Extension Block Ground Floor Room no:4, PGIMER, Chandigarh-160012
Chandigarh CHANDIGARH
9876602448
bhadadask@rediffmail.com
Dr Nilesh Bastewad
Renukai Critical Care & Multispeciality Hospital
Department of Clinical research, Room No. NA, Behind LIC Office, Bafna Road, Nanded-431602, Maharashtra, India
Nanded MAHARASHTRA
Department of Clinical research, Room No. NA, 1st & 7th floor, Sangini Hospital, Santorini Square, B/h Abhishree Complex, Star Bazar, Near Jodhpur Cross Roads, Satellite, Ahmedabad-380015
Ahmadabad GUJARAT
9825739241
drtapansah@gmail.com
Dr Santosh Saklecha
Santosh Hospital
Department of Clinical research, Room No. NA, Santosh Hospital, 6/1, Promenade Road, Behind Coles Park, Bengaluru, Karnataka- 560005
Bangalore KARNATAKA
Department of Clinical research, Room No. NA, C/3 Shree Complex , Opposite Mahavir Nagar , Manpada Road , Dombivli East 421201 Maharashtra, India .
Mumbai MAHARASHTRA
9870409142
deepak.varade@gmail.com
Dr Puneet Saxena
SMS Medical College & Hospitals
Department of Clinical research, Room No. NA, Room No.-219, 2nd Floor, SMS Medical College & Hospitals, Jaipur
Jaipur RAJASTHAN
9414079182
puneetsaxena96@yahoo.co.in
Dr Bharat Das
Sparsh Hospitals and Critical Care Private Limited
Department of Clinical research, Room No. NA, Plot No-A/407, Saheed Nagar, Bhubaneswar Khordha, Orissa - 751007 India
Khordha ORISSA
9938190845
bharatdas74@gmail.com
Dr Sunil Gupta
Sunils Diabetic Care and Research Centre Pvt. Ltd
Department of Clinical research, Room No. NA, 42, Lendra Park, Ramdas Peth -440010 Nagpur, Maharashtra, India
Nagpur MAHARASHTRA
9823152111
drsgupta_ngp@rediffmail.com
Dr Nikhil Bhagwat
Topiwala National Medical College & BYL Nair Ch. Hospital
Department of Clinical research, Room No. NA, Deaprtment of Endocrinology, 4th Floor, Room No. 419, College Building, Topiwala National Medical College and BYL Nair Ch. Hospital, Dr. A. L. Nair Road, Mumbai Central, Mumbai - 400008, Maharashtra, India
Mumbai MAHARASHTRA
9619221532
bhagwatnik@yahoo.co.in
Dr Shweta Bhandari
Vincare Hospital
Department of Clinical research, Room No. NA, 100 Feet Road, Opp. Petrol Pump, Bathinda, Punjab-151001, India
Bathinda PUNJAB
9316195900
drshwetabhandari23@yahoo.com
Dr Baratam Hari Kiran
Visakha Institute of Medical Sciences
Department of Clinical research, Room No. NA, Department of Endocrinology, Visakha Institute of Medical Sciences (VIMS), Hanumanthvaka, Chinnagadhilli Village, Visakhapatnam - 530040, Andhra Pradesh, India
Visakhapatnam ANDHRA PRADESH
Altezza Institutional Ethics Committee, Dr. Deepak Varade
Approved
Ethics Committee of Diabetes Care Foundation of India, Dr. Sunil Gupta
Approved
Ethics Committee of G.S.V.M. Medical College, Dr. Richa Giri
Approved
Ethics Committee. SMS Medical college and Attached Hospitals, Dr. Puneet Saxena
Approved
Ethics Committee. SMS Medical college and Attached Hospitals, Dr. Sanjay Saran
Approved
Good Society for Ethical Research, Dr. Vipul Gupta
Approved
HCG Multi Speciality Ethics Committee, Dr. Manoj Vithalani
Approved
IEC Diabetes Bhawan and Multispecialty hospital, Dr.Sanjay Mehendiratta
Approved
Independent Ethics Committee CLINISYD Research Global Solutions Pvt. Ltd., Dr. Madhusudan C
Approved
Institutional Ethics Committee for M V Hospital & Research Centre, Dr. Sandeep Kumar Gupta
Approved
Institutional Ethics Committee KIMS, Dr. Sambit das
Approved
Institutional Ethics Committee King George Hospital, Dr Aruna Mangipudi
Approved
Institutional Ethics Committee Mysore Medical College & Research Institute & Associate Hospitals, Dr. Summaiya Anjum
Approved
Institutional Ethics Committee of Endolife Speciality Hospital, Dr. Kongara Srikanth
Approved
Institutional Ethics Committee of Kovai Diabetes Specialty Centre and Hospital, Dr. R Balamurugan
Approved
Institutional Ethics Committee Osmania Medical College, Dr. Rakesh Kumar Sahay
Approved
Institutional Ethics Committee TNMC NAIR HOSPITAL, Dr. Nikhil Bhagwat
Approved
Institutional Ethics Committee, AIIMS, Dr. Rajesh Khadgawat
Submittted/Under Review
Institutional Ethics Committee, Bhailal Amin General Hospital, Dr. Atul Jani
Approved
Institutional Ethics Committee, COLLEGE OF MEDICINE & JNM HOSPITAL, Dr. Manas Ghosh
Approved
Institutional Ethics Committee, Dr Bharat Das
Approved
Institutional Ethics Committee, Dr. Kartikey Parmar
Submittted/Under Review
Institutional Ethics Committee, Nehru Hospital, Dr. Sanjaykumar Bhadada
Submittted/Under Review
Institutional Ethics Committee, Vincare Hospital, Dr. Shweta Bhandari
Approved
Institutional Ethics Committee-I, Dr. Anurag Ranjan Kundan Lal Lila
Approved
IPGME and RESEARCH OVERSIGHT COMMITTEE, Dr. Sujoy Ghosh
Submittted/Under Review
Kiran Hospital Ethics Committee, Dr. Shailesh Jethwa
Approved
Life care Hospital Institutional Review Board, Dr. L Srinivas Murthy
Submittted/Under Review
Mangal Murti Institutional Ethics Committee, Dr. Chimu Chopde
Approved
Medstar Speciality Hospital Ethics Committee, Dr Ambrish C
Approved
Muktai Hospital Institutional Ethics Committee, Dr. Ashutosh Sonawane
Approved
Narshima Saraswati Medical Foundation, Dr. Nilesh Jagdale
Approved
Renukai Institutional Ethics Committee, Dr. Nilesh Bastewad
Approved
Rudraksh Hospital Ethics Committee, Dr. Vipul Chavda
Approved
Sangini Hospital Ethics Committee, Dr Tapan Shah
Approved
Sangini Hospital Ethics Committee, Dr. Archit Parikh
Approved
Sangini Hospital Ethics Committee, Dr. Parag Shah
Approved
Santosh Hospital - Institutional Ethics Committee, Dr Santosh Saklecha
Approved
Vijan Hospital Ethics Committee, Dr Sujit Chandrartey
Approved
Visakha Institute of Medical Sciences, Dr. Baratam Hari Kiran
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Semaglutide-Reference (R)
Formulation: Multi-dose pre-filled pen for single-patient use,
Dose: Ozempic 0.25 mg (Semaglutide solution for injection in prefilled pen, 1.34 mg/mL, 1.5 mL), Ozempic 0.5 mg (Semaglutide solution for
injection in prefilled pen, 1.34 mg/mL, 1.5 mL or
0.68 mg/mL, 3 mL), Ozempic 1 mg (Semaglutide solution for
injection in prefilled pen, 1.34 mg/mL, 3 mL), Ozempic 2 mg (Semaglutide solution for injection in prefilled pen, 2.68 mg/mL, 3 mL)
Dosage Level: Once weekly
Timing of Dose: At any time of day, with or without meal
Route of Administration: Subcutaneous
Duration of dose: 24 weeks
Intervention
Semaglutide-Test (T)
Formulation: Multi-dose pre-filled pen for single-patient use,
Dose: Semaglutide Injection 0.68 mg/mL, 1.5 mL (0.25 mg dose) pre-filled pen, Semaglutide Injection 1.34 mg/mL, 1.5 mL (0.5 mg dose) pre filled pen, Semaglutide Injection 1.34 mg/mL, 3 mL (1 mg dose) pre-filled pen, Semaglutide Injection 2.68 mg/mL, 3 mL (2 mg dose) pre-filled pen
Dosage Level: Once weekly
Timing of Dose: At any time of day, with or without meal
Route of Administration: Subcutaneous
Duration of dose: 24 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 as well as in this protocol and is willing to participate in the study
2) Male or female participants with age 18 to 65 in completed years (both inclusive) at the time of signing the informed consent.
3) Participants with type 2 diabetes mellitus having Glycosylated Haemoglobin (HbA1c) greater than or equal to 7 percentage and less than 10.5 percentage at screening assessment.
4) Participants along with diet and exercise control, additionally on stable daily dose of metformin (greater than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening).
5) Contraceptive use by participants or participant’s partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical
studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4. Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly
effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency
when used consistently and correctly, as described in Appendix 4 during the
intervention period and for at least 2 months after the last dose of the study intervention.
The investigator should evaluate the effectiveness and the potential for contraceptive
method failure (e.g., noncompliance, recently initiated) of the contraceptive method in
relation to the first dose of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for
reproduction or retrieve them for their use during the recommended period of
contraception. A WOCBP agrees to seek advice about donation and cryopreservation of
germ cells. A WOCBP must have a negative highly sensitive serum Bhuman chorionic
gonadotropin (BhCG) test at Screening and urine BhCG test at Baseline. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum
pregnancy test is required. In such cases, the participant must be excluded from
participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. The investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk of inclusion of a woman with early undetected
pregnancy.
6) Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 months after the last dose of study intervention: Must agree not to plan to father a child or donate sperm for reproduction; PLUS, either of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR Must agree to use contraception barrier as detailed below a male participant must wear a condom when engaging in any activity that allows for the passage of ejaculate to another person
o With female partner use of an additional highly effective contraceptive method with a failure rate of less than 1 percentage per year as described in Appendix 4
7) The participant with adequate hematologic, liver, renal function and other parameters as
mentioned below, at screening assessment.
a) Haemoglobin greater than or equal to 9 g per dL
b) WBC count greater than or equal to 2500 per cu.mm
c) Neutrophil count greater than or equal to 1500 per cu.mm
d) Platelet count greater than or equal to 100,000 per cu.mm
e) Calcitonin less than or equal to 50 ng per L
f) Blood amylase less than or equal to 3 into ULN
g) Blood lipase less than or equal to 3 into ULN
h) Total bilirubin less than or equal to 1.5 into ULN
i) Alanine aminotransferase (ALT) less than or equal to 3 into ULN
j) Aspartate aminotransferase (AST) less than or equal to 3 into ULN
k) Alkaline phosphatase (ALP) less than or equal to 3 into ULN
l) Estimated glomerular filtration rate (eGFR) greater than 30ml per min per 1.73m2 as assessed by CKD-EPI 2021 equation
ExclusionCriteria
Details
1) Known allergies, hypersensitivity, or intolerance to any of the study interventions and other GLP-1 receptor agonists, or components excipients thereof (refer to the SmPC of Ozempic), or drug or other allergies that, in the opinion of the investigator, contraindicates
participation in the study.
2) Participants with Fasting blood glucose greater than or equal to 270 mg per dL at screening.
3) Participants with Body Mass Index greater than or equal to 45 kg per m2 at screening.
4) Contraindications or limitations for administration of investigational intervention according to SmPC of Ozempic.
5) Treatment with any medication for diabetes or obesity 12 weeks or less before screening
[other than metformin, or short-term insulin (less than or equal to 14 days in total).
6) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the
first dose of investigational intervention.
7) Positive hepatitis C antibody test result at screening or within 3 months prior to starting the
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to
prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is
obtained.
8) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
9) Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.
10) Participants with a documented medical history of uncontrolled, clinically significant intercurrent medical conditions that, in the investigators opinion, could affect weight and glucose metabolism.
11) Continuous or cumulative use of systemic glucocorticoids for more than 14 days within 3 months before screening (systemic glucocorticoids: intravenous, oral or intra articular glucocorticoid treatment).
12) Plan to receive glucocorticoids, immunosuppressants, or other drugs (except topical medications and inhaled preparations) that are assessed as unsuitable during the study by the investigator.
13) Participants with documented diagnosis of type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing syndrome or acromegaly-associated diabetes).
14) History or presence of malignancy within the past 5 years except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer
15) Have a history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis or hyperosmolar hyperglycaemic state) within 6 months before screening.
16) Participants who have undergone bariatric surgery within 12 months prior to screening.
17) Participant with clinically significant current or recent [within the past 90 days before
randomization (unless otherwise specified below)] cardiac conditions as defined below:
a) Acute coronary syndrome, stroke [including transient ischemic attack (TIA)] or other
ischemic event or thromboembolic event [e.g., deep vein thrombosis (DVT), pulmonary
embolism] within the past 90 days prior to randomization.
b) Clinical risk assessment of cardiac function using the New York Heart Association Functional
Classification of Class III and IV presently.
18) History of proliferative retinopathy or diabetic macular oedema, or any other unstable retinopathy (rapidly progressive) recorded in medical history and may require treatment
during the study.
19) Participants with a history of acute chronic pancreatitis.
20) Received any other investigational intervention or used a drug releasing invasive investigational medical device within 3 months or 5 half lives prior to the first dose of study intervention, whichever is longer, or participant is currently enrolled in an investigational study.
21) Participants with known alcohol or other substance abuse within last one year of screening.
22) Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
23) Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time
of screening or during the study period.
24) Participants with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and or diastolic BP greater than or equal to 100 mmHg at screening. Note: If blood pressure is out of range, up to 2 repeated assessments are permitted no more
than 60 minutes apart. Participants may be re-tested or rescreened after initiation or
adjustments of antihypertensive medications to establish control.
25) Participants with any abnormality on 12-lead ECG at screening that in the opinion of the
investigator is clinically significant and is judged as potential risk for his her participation in the study.
26) Pre-planned surgery or medical procedure that would interfere with the conduct of the study.
27) Documented medical history of uncontrolled, clinically significant intercurrent medical
condition(s) for which, in the opinion of the investigator, participation would not be in the
best interest of the participant (e.g., compromise the well-being) or that could prevent, limit,
or confound the protocol-specified assessments.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To establish non-inferiority of semaglutidetest
compared to semaglutide-reference in
adult participants with type 2 diabetes
mellitus who are inadequately controlled on
metformin, in adjunct to diet and exercise
Change from Baseline to Week 24 in Glycosylated Haemoglobin (HbA1c)
Secondary Outcome
Outcome
TimePoints
To evaluate efficacy of semaglutide-test
compared to semaglutide-reference in adult
participants with type 2 diabetes mellitus who
are inadequately controlled on metformin, in
adjunct to diet and exercise.
a) Change from Baseline in HbA1c levels [Timeframe: Weeks 4, 8, 12, 16, 20].
b) Change from Baseline in Fasting Blood Glucose (FBG) levels [Timeframe: Weeks 4, 8, 12, 16, 20, and 24].
c) Change from Baseline in Postprandial Blood Glucose (PPBG) levels [Timeframe: Weeks 4, 8, 12, 16, 20 and 24].
d) Change from Baseline in Bodyweight and BMI [Timeframe: Weeks 4, 8, 12, 16, 20, and 24].
e) Change from Baseline in Fasting Lipid Profile
Parameters [Timeframe: Weeks 24].
f) Proportion of participants achieving HbA1c less than 7.0 percentage and less than 6.5 percentage from baseline [Timeframe: Weeks 12, 16, 20 and 24].
g) Proportion of participants receiving rescue
medications [Timeframe: Throughout the
study period].
h) Proportion of participants with weight loss
greater than or equal to 5 percentage , greater than or equal to 7.5 percentage and greater than or equal to 10 percentage at Week 24.
To evaluate the safety of semaglutide-test
compared to semaglutide-reference in adult
participants with type 2 diabetes mellitus who
are inadequately controlled on metformin, in
adjunct to diet and exercise
a) Incidence of TEAEs and SAEs [Timeframe:
Throughout the study period].
b) Proportion of participants requiring
hypoglycaemia management [Timeframe:
Throughout the study period].
To evaluate the immunogenicity of
semaglutide-test compared to semaglutidereference
in adult participants with type 2
diabetes mellitus who are inadequately
controlled on metformin, in adjunct to diet and
exercise.
Proportion of participants with anti-drug
antibodies (ADA) and Neutralizing Antibody
(NAb) [Timeframe: Baseline (Pre-dose),
Week 12, 20 & 24]
Target Sample Size
Total Sample Size="250" Sample Size from India="250" 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)
02/07/2025
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="7" 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 is a study to establish non-inferiority of Intas semaglutide subcutaneous injection against Innovator semaglutide (Ozempic, Novo Nordisk) subcutaneous injection in adult participants with type 2 diabetes mellitus who are inadequately controlled on metformin, in adjunct to diet and exercise