CTRI/2025/09/094452 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On:
09/06/2026
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.
Institutional Ethics Committee, Manglam Plus Medicity Hospital
Approved
Institutional Ethics Committee, Osmania Medical College
Approved
Institutional Ethics Committee, Subharti Medical College and Hospital
Approved
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)
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
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
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)= "314" Final Enrollment numbers achieved (India)="314"
Phase of Trial
Phase 3
Date of First Enrollment (India)
29/09/2025
Date of Study Completion (India)
19/05/2026
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
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.