CTRI/2025/03/082615 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On:
17/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to evaluate the efficacy and safety of Semaglutide Injection in patients with type 2 diabetes mellitus.
Scientific Title of Study
A Multicenter, Randomized, Comparative, Active-Controlled, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic in Type 2 Diabetes Mellitus.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2024/31, Version No.: 01 and Date Feb 14, 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Deven V Parmar
Designation
Chief Medical Officer and Head Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad GUJARAT 382213 India
Phone
2717665555
Fax
Email
dparmar@zydustherapeutics.com
Details of Contact Person Scientific Query
Name
Dr Kevinkumar Kansagra
Designation
Senior General Manager - Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad GUJARAT 382213 India
Phone
2717665555
Fax
Email
kevinkumarkansagra@zyduslife.com
Details of Contact Person Public Query
Name
Dr Hardik Pathak
Designation
General Manager - Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad GUJARAT 382213 India
Phone
2717665555
Fax
Email
Hardik.L.Pathak@zyduslife.com
Source of Monetary or Material Support
Zydus Lifesciences Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481,
Gujarat, India.
Primary Sponsor
Name
Zydus Lifesciences Limited
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar
Highway, Ahmedabad-382481, Gujarat, India.
Research Room, Beside NBMCH, Opp. Bharat Petrol Pump, Kawakhari, Siliguri-734012.
Darjiling WEST BENGAL
9821275226
aastha.clinical@gmail.com
Dr Chintan B Patel
Aatman Hospital
Research Room, 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058. Ahmadabad GUJARAT
9825182251
drchintan.cr@gmail.com
Dr Viswaprasad V
Abhayahasta Multispeciality Hospital
347/247, 2nd Cross, Kaggadasapura Main Road, Landmark Opp. to DARE, CV Raman Nagar, Bengaluru-560093. Bangalore KARNATAKA
9448278422
cr.abhayahasta@gmail.com
Dr Patel Manan Bharatkumar
Ananta Multispecilaity Hospital
Research Room, 4th Floor (416-418) Centre Point, Opp. Vrundavan Heights, Vande Mataram City to Savvy Swaraj Road, Chenpur, Gota, Ahmedabad-382470.
Ahmadabad GUJARAT
9898377498
patelmanan15190@yahoo.com
Dr M Swapna
Gandhi Hospital
In Patient Block, 3rd Floor, Department of General Medicine, Musheerabad, Secunderabad-500003.
Hyderabad TELANGANA
9885144447
drswapna999@gmail.com
Dr Budithi Sudarsi
Government Medical College, Government General Hospital
Department of General Medicine, Cantonment, Vizianagaram-535003.
Vizianagaram ANDHRA PRADESH
9550845095
drbsudarsiresearch@gmail.com
Dr Kanugula Sudheer
Great Eastern Medical School and Hospital
Research Room, Ragolu, Srikakulam-532484. Srikakulam ANDHRA PRADESH
9666123122
drksudheerresearch@gmail.com
Dr S K Gautam
GSVM Medical College
Post Graduate Department of Medicine, LLR Hospital, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar UTTAR PRADESH
0512-2535483
dr.gautamhal@gmail.com
Dr Ansari Rizwanahmed Nurulhasan
Hope Well Medical Hospital
Research Room, Block G, 1st Floor, 101, 102, Sumel-8, Nr. Ajit Mill Char Rasta, Rakhiyal, Ahmedabad-380023.
Ahmadabad GUJARAT
9033884736
drrizwanansari@yahoo.com
Dr Surya Veeramani Kartheek Adhikarla
King George Hospital
Department of General Medicine, Rajendra Prasad Ward, Maharanipeta, Visakhapatnam-530002. Visakhapatnam ANDHRA PRADESH
9703586435
drasvkartheekresearch@gmail.com
Dr Gouranga Sarkar
Life Line Diagnostic Centre cum Nursing Home
Research Room, 4A, Wood Street, Kolkata-700016.
Kolkata WEST BENGAL
8910236595
drgsmed@gmail.com
Dr Prabhat Kumar Sharma
Maharaja Agrasen Superspeciality Hospital
Research Room, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039. Jaipur RAJASTHAN
9983995050
pksharma.clinical@gmail.com
Dr Shravan Kumar Ankathi
Mahatma Gandhi Memorial Hospital
Research Room, Sherpura, Warangal-506002. Warangal TELANGANA
9985579753
drshravanankathi.krcwgl@gmail.com
Dr Raja Bhattacharya
Medical College and Hospital
Department of Medicine, MCH Building, 2nd Floor, 88 College Street, Kolkata-700073. Kolkata WEST BENGAL
8100273048
rbrbhattacharya@gmail.com
Dr Kaushalendra Nath Tripathi
Motilal Nehru Medical College & Associate Swarooprani Nehru Hospital
Department of Medicine, Prayagraj-211001.
Allahabad UTTAR PRADESH
7007486535
kaushalendranaththripathi@gmail.com
Dr Sumit Anand
NIMS Heart and Brain Hospital
Research Room, B28, 29, Govind Marg, Raja Park, Jaipur-302004.
Jaipur RAJASTHAN
9929082000
nhbh.clinical@gmail.com
Dr Vijaykumar Shivajirao Patil
Prakash Institute of Medical Sciences & Research (PIMS&R)
Research Room, Urun-Islampur,Islampur-Sangali Road, Islampur, Tal-Walwa, Sangli-415409.
Sangli MAHARASHTRA
9371877555
mangovijay@gmail.com
Dr Vijaykumar Barge
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital
Department of Medicine, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416012. Kolhapur MAHARASHTRA
7969792775
drvijaybarge12@gmail.com
Dr Sagar Vivek Redkar
Redkar Hospital and Research Centre
Research Room, Mumbai-Goa Highway, Oxelbag, Dhargal,Tal-Pernem, Goa-403513. North Goa GOA
7969792769
redkardr.sagar@gmail.com
Dr Veer Bahadur Singh
Sardar Patel Medical College & A.G. Hospitals
Department of Medicine, Sardar Patel Colony, Bikaneer-334001. Bikaner RAJASTHAN
9414136888
vbsingh2@rediffmail.com
Dr Shrikant Somani
Shaleen Hospital Multispeciality LLP
Research Room, Shaleen Plaza, 4th & 5th Floor, Sola Gam Road, Near Mangaldeep Party Plot, Ahmedabad-380060. Ahmadabad GUJARAT
8447618387
shri.somani.2004@gmail.com
Dr Shalin J Shah
Sheth Vadilal Sarabhai General Hospital & Sheth Chinai Maternity Hospital
Institutional Ethics Committee, Motilal Nehru Medical College
Approved
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)
Approved
Kakatiya Institutional Ethics Committee, Kakatiya Medical College (Mahatma Gandhi Memorial Hospital)
Approved
Prakash Medical College Institutional Ethics Committee, Prakash Institute of Medical Sciences & Research (PIMS&R)
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College Institutional Ethics Committee 2 (RCSMGMCIEC2), Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital
Approved
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Sangini Hospital Ethics Committee C/o Sangini Hospital - Hope Well Medical Hospital
Approved
SMC Heart Institute Institutional Ethics Committee, SMC Heart Institute and IVF Research Centre
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Biologic Injection (Semaglutide) 2 mg/1.5 mL (1.34 mg/mL) pre-filled pen, 4 mg/3 mL (1.34 mg/mL) pre-filled pen and 8 mg/3 mL (2.68 mg/mL) pre-filled pen
Comparator product will be administered once weekly at any time of day, with or without meals for 24 weeks. Injection will be administered subcutaneously in the abdomen, thigh, or upper arm.
Intervention
Semaglutide Injection 15 mg/3 mL (5 mg/mL)
Test product will be administered once weekly at any time of day, with or without meals for 24 weeks. Injection will be administered subcutaneously in the abdomen, thigh, or upper arm.
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 ready to give written informed consent to participate in the study.
2. Patients with diagnosis of type 2 diabetes with glycosylated haemoglobin (HbA1c) more than or equal to 7.0 % and less than or equal to 10.5%.
3. Patients along with diet and exercise control additionally on stable daily dose of Metformin (more than or equal 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening.
4. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence).
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age].
5. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes.
2. Patients with fasting plasma glucose (FPG) more than or equal to 270 mg/dL at screening.
3. Treatment with any medication for diabetes or obesity 90 days or less before screening [other than Metformin, or short-term insulin (less than or equal to 14 days in total)].
4. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
5. Serum Calcitonin level more than or equal to 50 ng/L at screening
6. History of pancreatitis (acute or chronic).
7. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack within the past 180 days prior to the day of screening.
8. Subjects presently classified as being in New York Heart Association (NYHA) Class and III or IV.
9. Patients with planned coronary, carotid or peripheral artery revascularization known on the day of screening.
10. Patients having significant renal (estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m2, as calculated on MDRD formula) or hepatic impairment (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase (ALP) greater than 3 x upper limit of normal [ULN]), total bilirubin greater than 1.5 x ULN; hemoglobin less than 9 g/dL, WBC count less than 2500/mm3 (less than 2.5 × 103/μL), neutrophil count less than 1500/mm3 (less than 1.5 × 103/μL), platelet count less than 100 ×103/mm3 (less than 100 × 103/μL).
11. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas).
12. Proliferative retinopathy or maculopathy requiring acute treatment.
13. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g., Orlistat, thyroid hormones, corticosteroids).
14. Patients with history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
15. 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).
16. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period.
17. 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.
18. Pre-planned surgery or medical procedure that would interfere with the conduct of the study.
19. Patients with known alcohol or other substance abuse within last one year of screening.
20. Employee of the Sponsor/CRO, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor/CRO or the Investigator.
21. 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
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in HbA1c from baseline at the end of Week 24.
Baseline and Week 24.
Secondary Outcome
Outcome
TimePoints
Change in HbA1c from baseline at the end of Week 4, 8, 12, 16 and 20.
Adverse events and Serious adverse events (SAE) reported during the study.
Throughout the study.
Number of patients requiring hypoglycaemia management.
Throughout the study.
Number of patients discontinued due to AEs during course of trial.
Throughout the study.
Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (Nab) at week 24 compared to pre-dose (enrolment, Day 0 – visit 2).
Day 0 and Week 24.
Target Sample Size
Total Sample Size="314" Sample Size from India="314" Final Enrollment numbers achieved (Total)= "314" Final Enrollment numbers achieved (India)="314"
Phase of Trial
Phase 3
Date of First Enrollment (India)
24/03/2025
Date of Study Completion (India)
24/10/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
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 Multicenter, Randomized, Comparative, Active-Controlled, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic in Type 2 Diabetes Mellitus.
The patients with T2DM with diet and exercise control, additionally on stable daily dose of metformin (more than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to screening will be screened (visit 1) within 2 weeks prior to their enrolment. The eligible patients will then be enrolled and randomized to either of the 2 study groups as per their randomization number on baseline visit (visit 2, week 0, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), week 16 (visit 6), week 20 (visit 7) and week 24 (visit 8 - End of Treatment [EOT]). After 2 weeks of treatment, there will be a safety follow-up through telephonic visit at week 26 (visit 9 - End of Study [EOS]). This will be a parallel group study and all the enrolled patients will be instructed to take the study medications for a treatment period of 24 weeks.
Both the Test product and Comparator product will be administered once weekly at any time of day, with or without meals for 24 weeks. If a dose is missed, the missed dose will be administered within 5 days of the missed dose. Injection will be administered subcutaneously in the abdomen, thigh, or upper arm. Apart from study medications, throughout the treatment period, all subjects will receive stable daily dose of metformin (more than or equal to 1500 mg or maximum tolerated dose).