CTRI

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CTRI Number

CTRI/2025/06/088947 [Registered on: 16/06/2025] Trial Registered Prospectively

Last Modified On:

06/02/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Other

Public Title of Study

Study to check the effect 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 of MSN Laboratories Private Limited in Comparison with Ozempic (Semaglutide) Injection of Novo Nordisk in Patients with Type 2 Diabetes Mellitus

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
MSN/SEMA/Phase-III/2024-2025 V 2.0 Dated 03/MAR/ 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Mr Chandu Gangadhar Devanpally
Designation	Founder & Managing Director
Affiliation	Ardent Clinical Research Services
Address	office no 07A106 7th floor wework krishe emrald building laxmi cyber city whitefields road kondhapur Hyderabad TELANGANA 500081 India
Phone	9545817447
Fax	-
Email	cdevanpally@ardent-cro.com

Details of Contact Person
Scientific Query

Name	K Ravindar reddy
Designation	Sr Gr Manager Indian regulatory Affiars
Affiliation	MSN Laboratories Pvt Ltd
Address	MSN House Plot No C 24 Industrial Estate Sanathnagar knodapur road hyderabad Hyderabad TELANGANA 500018 India
Phone	9912099129
Fax	-
Email	krreddy@msnlabs.com

Details of Contact Person
Public Query

Name	Mr Chandu Gangadhar Devanpally
Designation	Founder & Managing Director
Affiliation	Ardent Clinical Research Services Pvt Ltd
Address	Room no 01 3rd floor office no 302 303 nyati unitree building yerwada Pune MAHARASHTRA 411006 India
Phone	09545717447
Fax	-
Email	cdevanpally@ardent-cro.com

Source of Monetary or Material Support

MSN House Plot No C 24 Industrial Estate Sanathnagar knodapur road hyderabad 500018

Primary Sponsor

Name	M/s MSN Laboratories Private Limited
Address	MSN House Plot No C 24 Industrial Estate Sanath Nagar Hyderabad 500018 Telangana India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Not Applicable

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 13
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Prashant Potdar	Accord hospital	Research department, Basment Plot No 1 Spine Rd beside FDA Sant Nagar Moshi Pradhikaran Sector Number 4 Moshi Pimpri Chinchwad Maharashtra 412105 Pune MAHARASHTRA	8440213193 - pashya2511@gmail.com
Dr Suhas Gopal Erande	Akshay Hospital	Clinical research department ground floor Rama Vasudev Apt Opp SNDT college near SBI bank Karve Road Pune 411004 India Pune MAHARASHTRA	9822025149 - drsse@rediffmail.com
Dr Siddiqui Md Sabah	All India Institute of Medical Sciences	All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur 492099 India Raipur CHHATTISGARH	8518881911 - dr.sabahsiddiqui@gmail.com
Dr Surendran Dansekaran	Delta Diabetic Centre	First floor room no 01 OPD block Delta Diabetes centre D-125 10 th cross Thillai nagar East Trichy 620018 Tamilnadu India Tiruchirappalli TAMIL NADU	9176600123 - Surendranresearchunit@gmail.com
Dr S S V V Narasinga Rao	Govt Medical College Govt General Hospital	OPD Block Room no 13 1st floor Govt Medical College Govt General Hospital Srikakulam Balaga Srikakulam Andhra Pradesh 532001 India Srikakulam ANDHRA PRADESH	9652160975 - drnarasingaraossvv@yahoo.com
Dr Richa Giri	GSVM medical college	Postgraduate Department of Medicine OPD number 08 ground floor GSVM Medical College Kanpur 208002 UP India Kanpur Nagar UTTAR PRADESH	8400331045 - krricha227@gmail.com
Dr Harshavardhan L	K R hospital Mysore medical college and research Institute	Room No 01 Jayadeva Block KR Hospital 1st Floor Oncology Ward Opd No 23 Department of Oncology K R Hospital Mysore Medical College and Research Institute irwin road myore 570001 Mysore KARNATAKA Mysore KARNATAKA	9663515531 - harshavardhanmed@gmail.com
Dr Rajashekhar S	Mandya Institute of Medical Science	Research Department 1st floor Bengaluru Mysuru Main Road Mandya 571401 Karnataka India Mandya KARNATAKA	7904026366 - dr.rajashekhars1983@gmail.com
Dr Vivek Shejole	medipoint Hospitals Pvt. Ltd.	Medipoint Hospitals Pvt.Ltd 241 by 1 New D P Road Aundh Pune 411007 Maharashtra lndia Pune MAHARASHTRA	9890847636 - drvivek.medipoint@gmail.com
Dr Rashmi	Nano Hospital	Clinical Research Unit 4 th Floor Nano Hospitals 79 Sir M Visveswaraya road Near Arekere Sai Baba temple Off Bannergatta road Bangalore 560076 India Bangalore KARNATAKA	9632588967 - clinicalresearchstudies23@gmail.com
Dr Kshikrsagar Ketan Ravindra	Sangvi Research Multispeciality Hospital	5th Floor Clinical Research Department Sangvi Multispeciality Hospital S No 71/1/2/189 C S no 2387 Krushna Chowk New Sangvi Pune MAHARASHTRA	9049002749 - drketan.sangvihospital@gmail.com
Dr Shravan Kumar Ankathi	St Anns General and Cancer Hospital	OPD block room no 01 ground floor St Anns General and Cancer Hospital Kazipet Warangal Telangana 506004 India Warangal TELANGANA	9985579753 - drshravanankathi.krcwgl@gmail.com
Dr Pravin Supe	Supe Heart and Diabetes Hospital and Research Centre	Supe Heart and Diabetes Hospital and Research Centre Nashik Gharapure Ghat Rd near Rungta High School Ashok Stambh Raviwar Karanja Panchavati Nashik Maharashtra 422002 Nashik MAHARASHTRA	9405366165 - drsupe1972@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 13
Name of Committee	Approval Status
Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre	Approved
Central Independent Ethics Committee	Approved
Central Independent Ethics Committee	Approved
IEC-SANGVI MULTISPECIALITY HOSPITAL	Approved
Instititional Ethics committee Mandya institute medical devices	Approved
Institutional Ethics Committee AIIMS Raipur	Approved
Institutional Ethics Committee government medical college and government general hospital srikakulam	Approved
Institutional Ethics Committee GSVM	Approved
Institutional Ethics Committee Mysore Medical College and Research Institute	Approved
Penta-Med Ethics Committee Medipoint Hospitals	Approved
Sri Durgamba Independent ethics commitee	Approved
St Ann’s Institutional Ethics Committee	Approved
SUPE hospital ethics committee	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	Ozempic® (Semaglutide) Injection	Ozempic® (Semaglutide) 2 mg/3 mL (0.68 mg/mL) pre-filled pen 4 mg/3 mL (1.34 mg/mL) prefilled pen and 8 mg/3 mL (2.68 mg/mL) manufactured by Novo Nordisk and supplied by Injections are to be taken subcutaneously once a week on the same day each week at any time of the day with or without meals for 24 weeks of treatment duration Participants will continue to receive metformin at prestudy dose for entire study duration of 24 weeks
Intervention	Semaglutide Injection	Semaglutide Injection 2 mg/3 mL (0.68 mg/mL) prefilled pen 4 mg/3 mL (1.34 mg/mL) prefilled pen and 8 mg/3 mL (2.68 mg/mL) supplied by M/s MSN Laboratories Private Limited Injections are to be taken subcutaneously once a week on the same day each week at any time of the day with or without meals Participants for total 24 weeks duration and subject will continue to receive metformin at prestudy dose for entire study duration of 24 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1 Male or female subject greater than 18 to less than 65 years of age who are willing to provide the written informed consent 2 Subject with Type 2 diabetes mellitus for at least 1 year prior to baseline visit 3 Subjects receiving 2 or more Oral hyperglycemic medications (OAMs at stable doses for 12 weeks prior to screening with metformin greater than 1500 mg per day 4 Glycated hemoglobin greater than 8.0% and less than 10.5 percentage 5 Ability and willingness to administer study medication weekly once as injections to abdomen thigh or upper arm 6 Female adult subject who is non pregnant non lactating 7 Female subject participating in a study is capable of bearing children but is using a reliable form of birth control throughout the study as determined by the investigator 8 As determined by the investigator, the subject should be capable and willing to do the following a Perform self monitored blood glucose (SMBG) b Complete subject diaries as instructed c Be receptive to diabetes education d Be able and willing to adhere to the protocol requirements

ExclusionCriteria

Details

1Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation
2Surgical or medical condition that in the judgment of the Investigator or Sponsor could interfere with test product to be used
3Renal system
Subject with clinically significant abnormal Renal Function Test parameters
Subject with abnormal eGFR less than 30 mL per min per 1.73 m2
Subjects with clinically significant hyponatremia as per blood biochemistry results at screening
Subject with clinically significant hyperkalemia and hypokalemia as per blood biochemistry results at screening
4Hepatic system
Subject with abnormal Liver Function Test parameters with values more than 2.5 times the upper limit of normal
5 Endocrine system
Subject with abnormal Thyroid Function Test
Subject with Type 1 Diabetes Mellitus
Subject with acute or chronic pancreatitis
Calcitonin levels greater than or equal to 100 ng per L at screening
6Cardiovascular system
Inadequately treated hypertension systolic greater than or equal to 150 mm Hg or diastolic greater than or equal to 100 mm Hg
Subject with history of atrial fibrillation OR sick sinus syndrome OR atrioventricular block II III Grade AVB II III without pacemaker
Subject with known case of symptomatic congestive heart failure unstable angina pectoris myocardial infarction percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery sinus node dysfunction and any clinically significant cardiac arrhythmias
Subject is a known case of Stroke
7 Cerebrovascular system
Subject with cerebrovascular disease
8 Other disease conditions
Subject with clinical history of Bronchospastic disorders Subject with medical history of Oncological Conditions for the last 2 years Subject with known case of Epileptic seizures
Subject with clinical history of bipolar disorder who are taking lithium etc Subject with history of muscular dystrophy
History of non arteritis central retinal vein occlusion or retinopathy
9 Trial related conditions
Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent
Currently taking prohibited concomitant medication listed and inability unwillingness to discontinue them for the entire study period
Suspected inability or unwillingness to comply with the study procedures
Women of childbearing potential to use proper contraceptive methods to avoid pregnancy during study period

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1Changes in HbA1c value	1Baseline to end of treatment (week 24)

Secondary Outcome

Outcome	TimePoints
1Changes in HbA1c 2Changes in fasting blood glucose (FBG) compared 3Changes in 2 hours postprandial blood 4Changes in body weight and BMI compared 5Incidence and rate of hypoglycemic episodes. 6The percentage of participants reaching HbA1c target of 7 % 7Proportion of participants receiving rescue medications	1from baseline after 12 weeks visit 5 of treatment 2from baseline to week 4 week 8 week 12 week 16 and week 24 of treatment 3from baseline after 12 weeks visit 5 of treatment 4glucose from baseline to week 4 week 8 week 12 week 16 and week 24 of treatment 5from baseline to 12 weeks 24 weeks of treatment. 6week 12 and week 24 7Baseline through Week 24

Target Sample Size

Total Sample Size="296"
Sample Size from India="296"
Final Enrollment numbers achieved (Total)= "296"
Final Enrollment numbers achieved (India)="296"

Phase of Trial

Phase 3

Date of First Enrollment (India)

27/06/2025

Date of Study Completion (India)

02/01/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

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 of MSN Laboratories Private Limited in Comparison with Ozempic (Semaglutide) Injection of Novo Nordisk in patients with Type 2 Diabetes Mellitus

The study will randomize approximately 296 participants

The screening period will be 1 week During the screening period after obtaining the written informed consent participants will be screened by undergoing various assessments as mentioned in the Schedule of Events treatment arm as per the dosing schedule given below

Week 0 All participants will receive the initial dose of 0.25 mg once weekly for 4 weeks.

Week 4 All participants will be up titrated to the dosage of 0.5 mg once weekly for next 4 weeks

At week 8 Participants with HbA1c less than or equal to 7.5 percentage will continue to receive 0.5 mg dosage once weekly.

Participants with HbA1c greater than or equal to 7.5% will be titrated to a dose of 1 mg dosage once weekly for the next 4 weeks week 8 to 12

At week 12 to week 24

1 Participants with HbA1c less than 7.5 percentage will continue to receive the ongoing dose.

2 Participants with HbA1c greater than or equal to 7.5 percentage and ongoing dose 0.5 mg will be up titrated to a dose of 1 mg dose

3 Participants with HbA1c greater than or equal to 7.5 percentage and ongoing dose 1 mg will be up titrated to a dose of 2 mg dose

Efficacy evaluations will be done by analyzing change from baseline in HbA1c levels PPBG levels FBG levels body weight and BMI fasting blood lipids and systolic and diastolic blood pressure Proportion of participants achieving HbA1c less than 7.0% and proportion of participants receiving rescue medications will also be evaluated as a part of efficacy evaluation