CTRI/2025/09/094452 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On:
09/09/2025
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.
Scientific Title of Study
A Phase III, Randomized, Open Label, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic Semaglutide Injection in Patients with Type 2 Diabetes Mellitus.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2024/33, Version No.: 01 and Date Jan 24, 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.), Hyderabad.
Medchal TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.), Hyderabad.
TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Vipen Seth
Designation
President – Drug Regulatory Affairs
Affiliation
Precise Biopharma Pvt. Ltd.
Address
E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai.
Mumbai (Suburban) MAHARASHTRA 400078 India
Phone
8860833301
Fax
Email
vipen@precisegroup.co.in
Source of Monetary or Material Support
Precise Biopharma Pvt. Ltd., E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai-400078, Maharashtra, India.
Primary Sponsor
Name
Precise Biopharma Pvt. Ltd.
Address
E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai-400078, Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 30
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sagorika Mullick
Abhayahasta Multispeciality Hospital
Research Room, 347/247, 2nd Cross, Kaggadasapura Main Road, CV Raman Nagar,
Bengaluru-560093. Bangalore KARNATAKA
9845208292
sagorika.mullick@gmail.com
Dr Shilpa Bawankule
Acharya Vinoba Bhave Rural Hospital
Department of Medicine, Datta Meghe Institute of Higher Education & Research, Sawangi (Meghe), Wardha-442001.
Wardha MAHARASHTRA
9673288892
drshilpagaidhane@gmail.com
Dr Md Sabah Siddiqui
All India Institute of Medical Sciences
Department of General Medicine, D Block, Gate No. 04,
G.E. Road, Tatibandh, Raipur-492099. Raipur CHHATTISGARH
8518881911
dr.sabah@aiimsraipur.edu.in
Dr Sunil Ramdas Pawar
Baramati Hospital Pvt. Ltd.
Research Room, Behind Kavivarya Moropant Natyamandir, Ring Road, Baramati, Pune-413102. Pune MAHARASHTRA
8889831973
7pawarsunil21@gmail.com
Dr Smita Patil
D. Y. Patil University School of Medicine & Hospital
Research Room, Nerul, Navi Mumbai-400706. Mumbai (Suburban) MAHARASHTRA
7969792774
spsmita10@gmail.com
Dr Sunil Kumar Gupta
G S Medical College and Hospital
Research Room, NH-24, Pilkhuwa, Hapur-245304.
Ghaziabad UTTAR PRADESH
7969792757
drsunilkumargupta2@gmail.com
Dr Murali Krishna M
Gandhi Hospital
In Patient Block, 3rd Floor, Department of General Medicine, Musheerabad, Secunderabad-500003. Hyderabad TELANGANA
8328648296
krish.chowdaryanand@gmail.com
Dr Sistla Lakshmi Sowjanya
Government Medical College, Government General Hospital
Department of General Medicine, Cantonment, Vizianagaram-535003. Vizianagaram ANDHRA PRADESH
9948811005
drlsowjanyaresearch@gmail.com
Dr S K Gautam
GSVM Medical College
Post Graduate Department of Medicine, LLR Hospital, Swaroop Nagar, Kanpur-208002. Kanpur Nagar UTTAR PRADESH
8400331062
dr.gautamhal@gmail.com
Dr Minguel Rufino Monteiro
Healthway Hospitals
Research Room, Plot No. 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Goa-403402.
North Goa GOA
7969792778
dr.rufinoresearch@gmail.com
Dr Anil Samaria
Jawahar Lal Nehru Medical College
Department of Medicine, Kala Bagh, Ajmer-305001.
Ajmer RAJASTHAN
9414008246
dr.anilsamaria@outlook.com
Dr A S Veeramani Kartheek
King George Hospital
Department of General Medicine, Rajendra Prasad Ward, Andhra Medical College, Maharanipeta, Visakhapatnam-530002. Visakhapatnam ANDHRA PRADESH
9703586435
drasvkartheekresearch@gmail.com
Dr Diptak Bhowmick
Life Line Diagnostic Centre cum Nursing Home
Research Room, 4A, Wood Street, Kolkata-700016. Kolkata WEST BENGAL
8777047635
diptak86@gmail.com
Dr Prabhat Kumar Sharma
Maharaja Agrasen Superspeciality Hospital
Research Room, Central Spine, Agrasen Aspatal Marg, Sector7, Vidyadhar Nagar, Jaipur-302039. Jaipur RAJASTHAN
Institutional Ethics Committee, Manglam Plus Medicity Hospital
Submittted/Under Review
Institutional Ethics Committee, Osmania Medical College
Submittted/Under Review
Institutional Ethics Committee, R. G. Kar Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, S. N. Medical College
Submittted/Under Review
Institutional Ethics Committee, Subharti Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)
Submittted/Under Review
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
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Submittted/Under Review
SMC Heart Institute Institutional Ethics Committee, SMC Heart Institute and IVF Research Centre
Submittted/Under Review
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
Reference Biologic Semaglutide Injection - 2 mg/3 mL (0.68 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 - (All manufactured by Novo Nordisk A/S, Novo Alle 1 2880, Hovedstaden, Bagsvaerd, Denmark).
Comparator product will be administered once weekly (0.25 mg dose, 0.5 mg dose, 1 mg dose and 2 mg dose) at any time of day, with or without meals for 24 weeks. Injection will be administered subcutaneously in the abdomen, thigh, or upperarm.
Intervention
Semaglutide Injection - 2 mg/3 mL (0.68 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 - (All Manufactured by Precise Biopharma Pvt. Ltd., India.).
Test product will be administered once weekly (0.25 mg dose, 0.5 mg dose, 1 mg dose and 2 mg dose) at any time of day, with or without meals for 24 weeks. Injection will be administered subcutaneously in the abdomen, thigh, or upperarm.
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) greater than or equal to 7.0 percent and less than or equal to 10.5 percent.
3. Patients 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.
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) greatet 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. Patients with history or presence of acute pancreatitis within the past 180 days prior to the screening visit.
5. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
6. Patients with serum calcitonin level greater than or equal to 50 ng/L at screening.
7. Patients with a known history of pancreatitis (acute or chronic).
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)= "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)
29/09/2025
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="1" Months="0" 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
A total of 314 patients with type 2 diabetes mellitus at geographically
distributed centres in India will be enrolled in this clinical trial to
evaluate the efficacy and safety of Semaglutide Injection compared to Reference
Biologic Semaglutide Injection. Patients with type 2 diabetes mellitus 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
screening and with glycated haemoglobin (HbA1c) greater than or equal to 7.0 percent to less than or equal to 10.5 percent will be
considered for enrollment in this study. The enrolled patients will be
allocated to either of the 2 study groups according to the centralized
computer-generated randomization plan in a 1:1 (test arm: comparator) ratio.
The patients with type 2 diabetes mellitus 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 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 drugs for a treatment period of 24 weeks.