CTRI/2025/02/080592 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On:
05/09/2025
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 Study to assess effectiveness and safety of Semaglutide Injection compared to Ozempic (semaglutide injection) in 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
ICR/23/010 version 2.0 dated 16/JAN/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President & Head_India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No 201, B1, Western Express Highway, Goregaon
(E)
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
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 House, Plot No 201, B1, Western Express Highway, Goregaon
(E)
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Dr Rajiv Yadav
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No 201, B1, Western Express Highway, Goregaon
(E)
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
Rajiv.Yadav1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited, Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Department of Endocrinology New Delhi 110029 India New Delhi DELHI
9999598468
yash_deep_gupta@yahoo.co.in
Dr Jhasaketan Meher
All India Medical Science
Department of General Medicine, D Block, Ground Floor, Great Eastern Road, Opposite Gurudwara, Tatibandh, Raipur Chhattisgarh 492099. Raipur CHHATTISGARH
9810780839
jak_42sss@yahoo.co.in
Dr Shrikant Vishnu Deshpande
Ashirwad Hospital and Research Centre
Clinical Research Department, Maratha Section, Near Jijamata Udhyan, Ulhasnagar-421004 Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
Dr Gayatri Amit Ghanekar
Asian Institute of Medical sciences
P/72, Milap Nagar,
MIDC, Dombivli East 421203.
Thane MAHARASHTRA
9167531680
drgayatrighanekar@gmail.com
Dr Avinash Narayan Kumbhar
Aster Aadhar Hospital
(Prerna Hospital Ltd), R.S. No. 628 B Ward Near Shastri Nagar, KMT Workshop Kolhapur -416012 Kolhapur MAHARASHTRA
9822620359
avinashkumbhar.kcro@gmail.com
Dr Parmar Kartikeya Ganpatlal
B J Medical College and Civil Hospital
D-4, First Floor, Department of Medicine, Asarwa, Ahmedabad-380016, Gujarat, India. Ahmadabad GUJARAT
9924643799
drkartik@gmail.com
Dr Ritesh Kumar
Banaras Hindu University
Institute of Medical Sciences, Varanasi Uttar Pradesh 221005 India
Varanasi UTTAR PRADESH
Reference biologic product will be administered once weekly at any time of day, with or without meals for 24 weeks.
Intervention
Semaglutide Injection 0.25 mg, 0.5 mg, 1 mg, 2 mg
Test product will be administered once weekly at any time of day, with or without meals for 24 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
2) Patients with diagnosis of T2DM with HbA1c ≥7.0% and ≤10.5%
3) Patients along with diet and exercise control, additionally on stable daily dose of metformin (≥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 the 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]
ExclusionCriteria
Details
1) Patients with history of hypersensitivity to any of the study drug or its excipients or to drugs of similar chemical classes
2) Patients with Fasting Blood Glucose (FBG) greater than or equal to 270 mg/dL at screening
3) Treatment with any medication for diabetes or obesity 90 days or less before screening
4) History of pancreatitis (acute or chronic)
5) 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
6) Patients presently classified as being in New York Heart Association (NYHA) Class III or IV
7) Patients with planned coronary, carotid or peripheral artery revascularisation known on the day of screening
8) Patients having significant renal or hepatic impairment.
9) History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) before screening
10) Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)
11) 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)
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 of screening
15) Employee of the Sponsor, 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 or the Investigator
16) Pregnant, lactating women or women who intends 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
Permuted block randomization, fixed
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change from Baseline in HbA1c
Timeframe: Baseline, Week 24
Secondary Outcome
Outcome
TimePoints
Change from Baseline in HbA1c levels
Timeframe: Baseline, Weeks 4, 8, 12, 16, and 20
Change from Baseline in FBG levels
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline in PPBG levels
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in Bodyweight and BMI
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline in Systolic and Diastolic Blood Pressure
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline in Fasting Lipid Profile Parameters
Timeframe: Baseline, Weeks 8 and 24
Proportion of patients achieving HbA1c less than 7.0%
Timeframe: Baseline, Weeks 8, 12, 16, 20 and 24
Proportion of patients receiving rescue medications
Timeframe: Throughout the study period
Incidence of TEAEs and SAEs
Throughout the study period
Proportion of patients requiring hypoglycaemia management
Timeframe: Throughout the study period
Proportion of patients with ADA and NAb
Timeframe: Baseline (Pre-dose), Week 24]
Target Sample Size
Total Sample Size="314" Sample Size from India="314" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Phase of Trial
Phase 3
Date of First Enrollment (India)
24/02/2025
Date of Study Completion (India)
Date Missing
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 phase 3, randomized, open-label, multicenter, parallel-group, active-controlled study. The study will be conducted at approximately 15-20 centers from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and EC approval.
The study will randomize approximately 314 patients. The screening period will be of 2 weeks. During screening period, after obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments (Appendix I). After confirming eligibility, patients will be randomized in 1:1 ratio (157 patients in Test arm and 157 in Comparator arm) into either Test arm or Comparator arm. Patients will receive either Semaglutide Injection or Reference Biologic Injection, subcutaneously, based on treatment arm as per the dosing schedule.
All patients will be provided with diary at the time of enrolment along with glucometer to record details about study drug administration, adverse events (AEs), rescue medications (if any) and self-monitoring of blood glucose levels. Patients will be required to bring completed diary and glucometer at each visit. Patient will be provided with ‘instruction for use’ document and will be trained on how to administer the study product.
During the study, assessments will be performed as mentioned in Schedule of Assessments (Appendix I). Patients terminating early from the study will be completing EOT assessments. EOS visit will be conducted after 2 weeks post EOT assessments. The efficacy and safety will be assessed during the study period.