CTRI/2025/03/081595 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On:
19/02/2026
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 Phase III Clinical Study to determine 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 III Study to evaluate the efficacy and safety of Semaglutide Injection in comparison with Ozempic (Semaglutide) Injection in Type 2 Diabetes Mellitus.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
ICS/NAT/2024-006 Version 3.0 Date 01 FEB 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
#512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura
North West DELHI 110034 India
Phone
9868679414
Fax
Email
kartik.sahni@insigniacs.com
Details of Contact Person Scientific Query
Name
Mr Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
#512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura
DELHI 110034 India
Phone
9868679414
Fax
Email
kartik.sahni@insigniacs.com
Details of Contact Person Public Query
Name
Dr G Venkata Ramana
Designation
Principal Scientist- Drug Development and Clinical Research
Affiliation
Natco Pharma Limited
Address
Natco House
Road No.2, Banjara Hills
Hyderabad-, India
Hyderabad TELANGANA 500034 India
Phone
914023547532
Fax
Email
gvramana@natcopharma.co.in
Source of Monetary or Material Support
Natco Pharma Limited,
Natco House
Road No.2, Banjara Hills
Hyderabad-500 034, India
Primary Sponsor
Name
Natco Pharma Limited
Address
Natco House
Road No.2, Banjara Hills
Hyderabad-500 034, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Natco Pharma Limited
Natco House
Road No.2, Banjara Hills
Hyderabad-500 034, India
15,Shashwat Ppposite, ESI Hospital, Gotri road- 390021 Vadodara GUJARAT
9904402122
amankhanna170974@gmail.com
Dr Prashant Jaikar
Belagavi Institute of Medical sciences
Department of Research, 1st Floor , Research Room, Dr BP. Ambedkar road, Sadashiv Nagar-590001, India
Belgaum KARNATAKA
8088907430
drprashantjaikar@gmail.com
DrDeshpande Neeta
Belgaum Diabetes Centre
Ground and Second Floor CTS,1574/1575 Maruti Galli, Belagavi Belgaum KARNATAKA
9880271313
neetarohit@gmail.com
Dr Rajesh Gosavi
Datta Meghe Medical College And Shalinitai Meghe Hospital and Research Centre
Department of Clinical Research, Ground Floor of Block G, Clinical research Room, Hingna Road, Wanadongri, - 440016, India
Nagpur MAHARASHTRA
9890225111
gosavirv.smhrc@gmail.com
Dr MV Rama Mohan
DEC Healthcare Hospital
Department of Clinical Research, 5th Floor, Clinical Reseach Room, 16-2-219, Pogathota- 524001, India
Nellore ANDHRA PRADESH
9490463301
rammohanmddm@gmail.com
Dr Govardhan Rao
Excel Hospital
Department of Research, 5th floor, Room no. 501, Excel Hospital, Plot No. 29, Old Alwal, Near IG, Statue, Banda Basti, Old Alwal, Alwal, Secunderabad -500010, India
Hyderabad TELANGANA
9440664042
goroshidrmanjunath@gmail.com
Dr Manjunath Goroshi
Goroshi Clinic Complete Hormone Care Superspeciality Diabetes, Thyroid and Endocrine Center
Department of Clinical Research, 1st Floor Clinical Research Room, Forun Builder(above Belgaum Diagnostics), SP office Road-590010, India Belgaum KARNATAKA
9930270424
goroshidrmanjunath@gmail.com
Dr Jitendra Singh Kushwaha
GSVM Medical College, Kanpur
Department of Medicine - 208002, India Kanpur Nagar UTTAR PRADESH
9918002260
drjskushwaha@gmail.com
Dr Parag Shah
Gujarat Endocrine Centre ( A unit of Gujarat Endocrin Pvt. Ltd.)
Department of Research, Research room, 5th floor, 518-526, Block – B, AWS-3, Opp. Manav Mandir, Nr. Helmet Circle, Memnagar – 380052, India Ahmadabad GUJARAT
9824042688
Paragendo@gmail.com
Dr Urman Dhruv
HCG Medisurge Hospital Ahemedabad
Department of Medicine, Mithakali Ellisbridge-380006, India Ahmadabad GUJARAT
7575010447
clinicalresearch.hms@hcg.com
Dr Anjali Rajan Pillay
Inamdar Multispecialty Hospital
Department of Research Research Room, Ground Floor, Admin Building, Fatima Nagar-411040, India Pune MAHARASHTRA
Reference drug will be administered once weekly subcutaneously at any time of day, with or without meals for 24 weeks.
Intervention
Semaglutide Injection 0.25mg, 0.5mg, 1mg, 2mg
Test drug will be administered once weekly subcutaneously 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 glycated haemoglobin (HbA1c) more than or equal to 7.0 percent and less than or equal to 10.5 percent
3. Patients with Body Mass Index BMI more than or equal to 18 kg per meter square.
4. Patients along with diet and exercise control, additionally on stable daily dose of metformin (more than or equal to 1500mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening.
5. 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.
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) more than or equal to 270mg per dL at screening.
3. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
4. Serum Calcitonin level more than or equal to 50 ng per L at screening.
5. History of pancreatitis (acute or chronic).
6. 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.
7. Patients presently classified as being in New York Heart Association (NYHA) Class III or IV.
8. Patients with planned coronary, carotid or peripheral artery revascularization known on the day of screening.
9. Patients having significant renal (estimated Glomerular Filtration Rate (eGFR) below
30mL per min per 1.73 msq, as calculated on MDRD formula) or hepatic impairment (aspartate
aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase (ALP) more than 3×upper limit of normal [ULN]), total bilirubin more than 1.5×ULN, hemoglobin less than 9 g per dL, WBC count less than 2500 per mmcube, neutrophil count less than 1500 per mm per cube, platelet count less than 100×1000 per mmcube.
10. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) before screening.
11. Proliferative diabetic retinopathy or maculopathy requiring acute treatment.
12. 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).
13. Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
14. 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).
15. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period.
16. Patients with any clinically significant laboratory abnormalities or 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.
17. Pre-planned surgery or medical procedure that would interfere with the conduct of the study.
18. Patients with known alcohol or other substance abuse within last one year of screening.
19. 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.
20. 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
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change from Baseline in HbA1c
Week 25
Secondary Outcome
Outcome
TimePoints
Change from Baseline in HbA1c levels
Weeks 5, 9, 13, 17, and 21
Change from Baseline in FBG levels
Weeks 5, 9, 13, 17, 21, and 25
Change from Baseline in postprandial blood glucose (PPBG) levels
Weeks 5, 9, 13, 17, 21, and 25
Change from Baseline in BMI
Weeks 5, 9, 13, 17, 21, and 25
Proportion of patients achieving HbA1c less than 7.0 percent
Weeks 9, 13, 17, 21 and 25
Proportion of patients receiving rescue medications
Throughout the study period
Target Sample Size
Total Sample Size="306" Sample Size from India="306" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Type 2 Diabetes Mellitus (T2DM) is characterized by
progressively diminished response to insulin also known as “Insulin Resistance”
that results in sequential adding of different oral and injectable medications
to achieve optimal glycemic control. First-line treatment strategies for T2DM
are lifestyle modification and use of Biguanides (Metformin,Proguanil)
and Insulin Secretagogues like Sulphonylureas (Tolbutamide, Glimepiride) and
Megaltidines class of drugs (Nateglinide and Repaglinides). However, almost 50%
of patients with T2DM will require additional antihyperglycemic medication(s)
within one year of diagnosis. Diabetes associations globally stress importance of
a patient-centered approach especially when choosing add-on therapy.
GLP-1 receptor agonists stimulate insulin
secretion and suppress glucagon release in a glucose-dependent manner, thereby
effectively controlling blood glucose in patients with T2DM without excess risk
of hypoglycaemia. The results from dedicated cardiovascular outcome trials have
shown their cardiovascular safety, and for some of them have also proven
additional cardiovascular benefits (liraglutide, subcutaneous semaglutide,
albiglutide and dulaglutide). As per the ADA guidelines, GLP-1 receptor
agonists have a high to very high efficacy in T2DM with no hypoglycaemia risk.
Semaglutide also has beneficial cardiovascular effects with neutral effects on
heart failure.
Natco Pharma Limited has developed a proposed
biosimilar to semaglutide Injection, (Ozempic®) and intends to conduct a phase III clinical
study in India. It is comparable to the RMP in terms of its physicochemical
characteristics, structure, and mechanism of action. Taking into account the
results of the analytical similarity, pharmacological, and toxicological
profiles of IMP, and previous clinical and marketing experience of Ozempic®,
the present study has been planned to compare the efficacy and safety of IMP versus
Ozempic® in T2DM.