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CTRI Number  CTRI/2025/07/091328 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Injection Semaglutide in Uncontrolled Diabetes Mellitus patients 
Scientific Title of Study   A Prospective, Multi-Centric, Randomized, Open label, Active-Controlled, Parallel Group, Comparative Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Hetero-Semaglutide injection and RMP-Semaglutide injection (Ozempic, Novo Nordisk) in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/SEMADM/10/2024; Version 1.1; Date 17.02.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubhadeep Sinha 
Designation  Senior Vice President and Head 
Affiliation  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sd.sinha@hetero.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sreenivasa Chary S 
Designation  Senior General Manager 
Affiliation  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sreenivasa.chary@hetero.com  
 
Details of Contact Person
Public Query
 
Name  Mohan Reddy Bandi  
Designation  General Manager 
Affiliation  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  B.MohanReddy@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad 
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 37  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Viswa prasad V  Abhayahasta Multispeciality Hospital  Department of General Medicine, Ground Floor, Site No 1- 2 Katha No. 347/247 2nd Cross Kaggadasapura Main Road, CV Raman Nagar-560093 India
Bangalore
KARNATAKA 
9448278422

cr@abhayahastahospital.com 
Dr Anand Vishal  ABVIMS, Dr. Ram Manohar Lohia Hospital  Department of Endocrinology, Room No 301, 3rd Floor, Baba Kharak Singh Marg-110001, India
New Delhi
DELHI 
9319803331

dranandvishal21@gmail.com 
Dr Noushadali Shaik  ACSR Government Medical College and Hospital  Department of General medicine, Room No 11, Ground Floor, G.T. Road, Nellore -524004, Andhra Pradesh India
Nellore
ANDHRA PRADESH 
9494828694

mddbnoal@gmail.com 
Dr Sachin Dethe  Altiuz Multispeciality Hospital & Research Centre   Department of General Medicine, Research Room, 1st floor, Link House, Link Road, Chincholi, Malad-400064
Mumbai
MAHARASHTRA 
9322532803

drsachin197818@yahoo.in 
Dr Deepak Gargi Pande  Dr. B.L.Kapur Memorial Hospital  Department of General Medicine Room No 28, Ground Floor, Pusa Road-110005, India
New Delhi
DELHI 
9818802981

doctorsblkkcr@gmail.com 
Dr Tinkal C Patel   Dr.M.K.Shah Medical College and Research Centre & Smt SMS Multispeciality Hospital  Department of Medicine, Room No 3 Blcok B, Ground Floor, Near Tapovan Circle, Visat-Gandhinagar, Highway, Chandkheda- 382424, India"
Ahmadabad
GUJARAT 
9898713223

drmkshahmc@gmail.com 
Dr L Suneel Kumar   Gandhi Hospital   Department of Medicine, 2nd Floor, Room No 01, Inpatient Block Musheerabad, Secunderabad, Telangana-500003, India.
Hyderabad
TELANGANA 
9000976655

drsunil@gmail.com 
Dr K Sunil Naik  Government Medical College and Govt.General Hospital (Old RIMSGGH)  Department of General medicine, Room No, 13, First Floor, Srikakulam-532001 Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH 
9440828299

drsunilnaikggh@gmail.com 
Dr Palaparthi Rajesh Kumar  Govt. Siddhartha Medical College  Department of General Medicine Room No 9 Ground Floor, Ring Road, Gunadala, Vijayawada-520008, Andhra Pradesh, India
Krishna
ANDHRA PRADESH 
8500540805

dr.rajeshpalaparthi@gmail.com 
Dr Sanket Chetanbhai Mathukiya  Hi Tech Multispeciality Hospital  Department of General Medicine, Room No 04, Ground Floor, Sector 3-D, Plot No. 1180, Gh Road, Near Gh-1 ½ Bus Stand, India.
Gandhinagar
GUJARAT 
9953214322

drsanketmathukiya16@gmail.com 
Dr Anil Samaria   Jawahar Lal Nehru Medical College  Department of Medicine, Ground Floor, Room No.99, Kala Bagh-305001, India.
Ajmer
RAJASTHAN 
9414008246

dr.anilsamaria@outlook.com 
Dr Biswaroop Mukherjee  Kasturi Das Memorial Superspeciality Hospital  Department of General Medicine, Room No 2, Ground Floor, A Unit of Dishari Health Point Pvt Ltd, Holding No-B1-38/1/New Santoshpur, Block-B, Road Bye Lane-1, P.O.- Santoshpur (M), P.S.- Maheshtala-700142, India.
Kolkata
WEST BENGAL 
9830839636

bm.clinicaltrial@gmail.com 
Dr Prabhat Kumar Sharma  Maharaja Agrasen Superspeciality Hospital   Department of General medicine, Room No B11, Basement Reseaserch Department Ground Floor, Central Spine, Agrasen Aspatal Marg, Sector7, VidyadharNagar, Jaipur, -302039 Rajasthan, India
Jaipur
RAJASTHAN 
9983995050

pksharma.clinical@gmail.com 
Dr B Thrilok Chander  Mahatma Gandhi Memorial Hospital  Department of General Medicine, Room No 1, Second Floor, Warangal,506002, Telangana, India.
Warangal
TELANGANA 
9160860777

thrilok73@gmail.com 
Dr Leelabati Toppo  Malla Reddy Narayana Multispeciality Hospital  Department of General Medicine Room No 1, Ground Floor, Suraram X Roads, Jeedimetla, Hyderabad-500055, Telangana, India.
Hyderabad
TELANGANA 
8886436633

leelabati.rath@gmail.com 
Dr Abhishek Prakash   Manglam Plus Medicity Hospital  Department of Endocrinology, Room No,601 6th Floor, Sector 05, Shipra Path, Mansarovar-302020 India",
Jaipur
RAJASTHAN 
9680040978

drmkshahmc@gmail.com 
Dr Anirban Sinha  Medical College and Hospital Kolkata  Department of Endocrinology Clinical Research Room, Fourth Floor, Kolkata 88, College Street, Kolkata, -700073, West Bengal India.
Kolkata
WEST BENGAL 
9830160050

Anirban.doc@gmail.com 
Dr Subhash Kumar  Medipulse Hospital  Department of Endocrinology, Clinical research department Lower Ground Floor, E4, MIA Basni II Phase, Opposite AIIMS Link Road, Jodhpur 342005, Rajasthan, India
Jodhpur
RAJASTHAN 
7300454987

endocrineacademic2020@gmail.com 
Dr Sirshendu Pal  Mitras Multispeciality Hospital   Department of General Medicine Room No 3, Ground Floor, ,1 Tilak Road Ward -12, Hakim para, Siliguri, Darjeeling, West Bengal-734001, India.
Darjiling
WEST BENGAL 
9474875556

info@hamsindia.com 
Dr Nutan Kumar Agrawal   MLB Medical College and Associated Hospital  Department of Medicine, Ground Floor, Room No.138, Kanpur Road-284128, India.
Jhansi
UTTAR PRADESH 
9839789378

dr_nutan_agrawal@yahoo.com 
Dr Kaushalendra Nath Tripathi  Motilal Nehru Medical College & Associate Swarooprani Nehru Hospital  Department of General Medicine Room No 3, Ground Floor, Swarooprani Nehru Hospital, Prayagraj, Uttar Pradesh -211002 India.
Varanasi
UTTAR PRADESH 
7007486535

kaushlendranathtripathi@gmail.com 
Dr Ramanbhai Gamabhai Patel  Namostute Hospital   Department of General Medicine Room No 105 ,First Floor Plot No-1285 Sector 6-D, GH-3 circle, Opposite, Civil Hospital, GandhiNagar382006, Gujarat, India
Gandhinagar
GUJARAT 
9898205641

drramanpatel22@gmail.com 
Dr Sunetra Mondal  Nil Ratan Sircar Medical College and Hospital   Department of Endocrinology Clinical Research Room, Second Floor, 138, A.J.C Bose Road, Raja Bazar, Kolkata, 700014 West Bengal, India.
Kolkata
WEST BENGAL 
9475738409

sunetra59@gmail.com 
Dr Deo Nidhi Mishra  Nirmal Hospital   Department of General Medicine Room No 1, Devalaya, Ground Floor, Opp. MLB Medical College, Gate No 3, Jhansi -284128 Uttar Pradesh, India.
Jhansi
UTTAR PRADESH 
9415031689

drmishra.nirmal@gmail.com 
Dr K Neelaveni  Osmania Medical College & Osmania General Hospital   Department of Endocrinology, 2nd Floor, Room No 306, Golden Jubilee Block, Afzalgunj-500012, India
Hyderabad
TELANGANA 
9848131182

neelaveni1@yahoo.co.in 
Dr Ashu Rastogi   Postgraduate Institute of Medical Education &Research (PGIMER)  Department of Endocrinology, Nehru Extension, Ground Floor, Room No 16, Sec-12-160012, India"
Chandigarh
CHANDIGARH 
9781001046

ashuendo@gmail.com 
Dr Parth Dineshbhai Patel  Rhythm Hospital   Department of General Medicine Room No 01, Second Floor, D-201, SF Fortune Atlantis, Kudasan, Gandhi Nagar,382421 Gujarat, India
Gandhinagar
GUJARAT 
8780089653

info@therhythmhospital.com 
Dr Prabhat Kumar Agrawal   S.N Medical College  Department of Medicine, Room No 12, Ground Floor, Near Central Library, Moti Katra Mantola - 282003, India.
Agra
UTTAR PRADESH 
9319250485

prabhatagrawal321@gmail.com 
Dr Veer Bahadur Singh  Sardar Patel Medical College and AG Hospitals  Department of General Medicine Room No 01, Ground Floor, Sardar Patel Colony, Bikaner, Rajasthan-334001 India
Bikaner
RAJASTHAN 
9414136888

Vbsingh2@rediffmail.com 
Dr Kannan Rajendran  Saveetha Medical College and Hospital  Department of General Medicine Room No 4, Sixth Floor Saveetha Nagar, Thandalam, Chennai-602105 Tamil Nadu India.
Chennai
TAMIL NADU 
9710071284

endork@yahoo.com 
Dr Moxit Sunilkumar Shah   Shashvat Surgicare Hospital  Department of Endocrinology, Ground Floor,Room No 101 Plot No 3,4, Shyam Residency, Kudasan-382421, India.
Gandhinagar
GUJARAT 
7073660927

shashvathospitalcr@gmail.com 
Dr Shalin J Shah   Sheth Vadilal Sarabhai General Hospital and Sheth Chinai Maternity Hospital  Department of Endocrinology, 2nd Floor, Research wing Room No. 201, Ellis bridge-380006, India
Ahmadabad
GUJARAT 
9924071369

drshalinjshah@gmail.com 
Dr Arvind Palawat  SMS Medical College and Hospital  Department of Medicine, Ground Floor, Room No 72, Dhanvantri OPD Block-302004, India.
Jaipur
RAJASTHAN 
9828025364

drpalawat@gmail.com 
Dr Ronak Gandhi   SN Medical College, Mathuradas Mathur Hospital  Department of Endocrinology, Room No 102, Ground Floor, Residency Road, Shashtri Nagar-342003, India.
Jodhpur
RAJASTHAN 
9001324190

sonu.ronak@gmail.com 
Dr A Venkateshwar Rao  St. Theresa’s Hospital   Department of General Medicine Room No 3, Ground Floor Sanathnagar, Hyderabad Telangana State 500018, India.
Hyderabad
TELANGANA 
9440040662

drvenkateshwarraoavula@gmail.com 
Dr Nitin Parikh  Trisha Multispeciality Hospital  Department of General Medicine, Room No 5, 6Th Floor, Dream Square, Chandlodia Rd Bridge, Akhbar Nagar, Nirnay Nagar-380013, India
Ahmadabad
GUJARAT 
9825412828

drncp2007@yahoo.co.in 
Dr Baratam Hari Kiran  Visakha Institute of Medical Sciences (VIMS)  Department of Endocrinology Room No 11, Ground Floor, Hanumanthawaka, Visakhapatnam-530040, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 
9959682999

drbharikiranresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 37  
Name of Committee  Approval Status 
Dr. B.L.Kapur Memorial Hospital Ethics Committee. Dr. B.L.Kapur Memorial Hospital, Academic Affairs Research and continuing Education  Submittted/Under Review 
Ethicare Ethics Committee  Submittted/Under Review 
Ethics Committee Nil Ratan Sircar Medical College and Hospital  Submittted/Under Review 
Ethics Committee SMS Medical College and Attached Hospitals  Approved 
Ethics Committee SP Medical College  Approved 
Ethics Committee St. Theresa’s Hospital   Approved 
Ethics Committee, Siliguri Sumita Cancer R.W and E Society  Submittted/Under Review 
Hi-Tech Ethics Committee, Hi Tech Multispeciality Hospital  Approved 
IEC Manglam Medicity Hospital   Approved 
IEC, Abhayahasta Superspeciality HospitalAbhayahasta Multispeciality Hospital  Approved 
IEC, Shashvat Surgicare Hospital Shashvat Surgicare Hospital  Submittted/Under Review 
Institutional Ethics Committee Aatman Hospital  Submittted/Under Review 
Institutional Ethics Committee Aatman Hospital, Aatman Hospital  Submittted/Under Review 
Institutional Ethics Committee Dr. S.N. Medical College  Submittted/Under Review 
Institutional Ethics Committee S.N Medical College  Submittted/Under Review 
Institutional Ethics Committee AC Subba Reddy ACSR Government Medical College and Hospital  Approved 
Institutional Ethics Committee Dr. M.K. Shah Medical College and Research  Submittted/Under Review 
Institutional Ethics Committee Government General Hospital and Srikakulam  Approved 
Institutional Ethics Committee Kakatiya Medical College  Submittted/Under Review 
Institutional Ethics Committee Malla Reddy Medical College for women  Approved 
Institutional Ethics Committee Medipulse Hospital  Approved 
Institutional Ethics Committee Nirmal Hospital  Approved 
Institutional Ethics Committee PGIMER  Submittted/Under Review 
Institutional Ethics Committee Shashvat Surgicare Hospital   Approved 
Institutional Ethics Committee SMC and GGH Govt. Siddhartha Medical College,  Approved 
Institutional Ethics Committee, ABVIMS, Dr. Ram Manohar Lohia Hospital  Submittted/Under Review 
Institutional Ethics Committee, Gandhi Medical/Hospital College  Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Institutional Ethics Committee, Kasturi Das Memorial Superspeciality   Approved 
Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital  Approved 
Institutional Ethics Committee, Medical College and Hospital for Human Research Kolkata  Submittted/Under Review 
Institutional Ethics Committee, MLB Medical College  Submittted/Under Review 
Institutional Ethics Committee, MLN Medical College Motilal Nehru Medical College  Submittted/Under Review 
Institutional Ethics Committee, Osmania Medical College  Approved 
Institutional Ethics Committee, Saveetha Medical College and Hospital  Approved 
Institutional Ethics Committee, Visakha Institute of Medical Sciences  Approved 
Rhythm Hospital Ethics Committee Rhythm Hospital  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 
Intervention  Hetero-Semaglutide injection  Start with 0.25 mg once weekly for 4 weeks followed by 0.5 mg once weekly for 4 weeks. Further dose titration to 1mg and 2mg will be done if HbA1c levels are above 7.5 percent. If the HbA1c levels are below 7.5 pecent after 4 weeks, same doe will be continued for another 4 weeks. 
Comparator Agent  RMP-Semaglutide (Ozempic injection, Novo Nordisk)  Start with 0.25 mg once weekly for 4 weeks followed by 0.5 mg once weekly for 4 weeks. Further dose titration to 1mg and 2mg will be done if HbA1c levels are above 7.5 percent. If the HbA1c levels are below 7.5 pecent after 4 weeks, same doe will be continued for another 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male or female patients aged 18-65 years with diagnosis of type 2 diabetes mellitus.
2. Patients who are on Metformin greater than or equal to 1500mg per day for about 12 weeks before screening.
3. Patients with glycosylated haemoglobin (HbA1c) greater than or equal to 7.0 percentage and less than or equal to 11.0 percentage at screening.
 
 
ExclusionCriteria 
Details  1. Patients with known Type I diabetes mellitus or secondary diabetes mellitus
2. Patients with history of two or more episodes of severe hypoglycemia within 6 months prior to screening
3. Patients having a history of metabolic acidosis or diabetic ketoacidosis or hyperosmolar state, with or without coma.
4. Patients with severe renal impairment as an estimated glomerular filtration rate less than 30 mL/min/1.73 meter square as calculated by chronic kidney disease-epidemiology collaboration as determined by central laboratory.
5. Patients with hyperthyroidism or hypothyroidism at screening (except those with stable drug dose control for more than 3 months and normal thyroid function tests) or clinically significant abnormal thyroid function test results at screening and requiring drug treatment.
6. Have been taking any other glucose lowering agent(s) other than metformin during the last 12 weeks prior to screening (short-term treatment (no longer than 14 days in total) with insulin in connection with inter-current illness allowed).
7. Patient with any of the following laboratory abnormality at screening
a. Haemoglobin less than 10 gm/dl
b. Neutrophils less than 1500/mm3
c. Platelets less than 100,000/mm3
d. Fasting plasma glucose greater than or equal to 270 mg/dL
e. Total bilirubin greater than 1.5 X ULN
f. ALT/ AST greater than 3 X ULN
g. Serum amylase and/or lipase greater than 3.0 X ULN
h. Serum calcitonin greater than 50 ng/L
i. QTc interval greater than 450 msec in men and greater than 470 msec in women 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in glycosylated haemoglobin (HbA1c)  Baseline to end of 24 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in HbA1c  Baseline to end of 12 Weeks 
The proportion of patients who achieved HbA1C less than 7.0 percentage  At the End of 12 and 24 Weeks 
Mean change in fasting plasma glucose (FPG) levels  Baseline to end of 4, 8, 12, 16, 20 and 24 Weeks 
Mean change in postprandial plasma glucose (PPG) levels  Baseline to end of 4, 8, 12, 16, 20 and 24 Weeks 
Mean change in body weight  Baseline to end of 12 and 24
Weeks. 
Proportion of patients who achieved body weight loss greater than or equal to 5 percentage and greater than or equal to 10 percentage   At the End of 12 and 24 Weeks. 
Proportion of patients who develop anti-drug antibodies (ADA) to Semaglutide  Baseline to end of 12 and 24
Weeks 
Proportion of patients with hypoglycaemic episodes  Baseline to end of 12 and 24
Weeks 
Treatment emergent clinical and laboratory adverse events
(TEAEs) 
Baseline to end of 24 Weeks 
Proportion of patients who require rescue medications  Baseline to end of 24 Weeks 
 
Target Sample Size   Total Sample Size="312"
Sample Size from India="312" 
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)   04/08/2025 
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)  Open to Recruitment 
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 randomized, multi-centre, open-label, parallel arm, active controlled, comparative clinical study, to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Hetero-Semaglutide injection and RMP-Semaglutide injection (Ozempic, Novo Nordisk) in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin. Patients who are on Metformin greater than or equal to 1500mg/day for about 12 weeks before screening and glycosylated haemoglobin (HbA1c) greater than or equal to 7.0 percentage and less than or equal to 11.0 percentage at screening will be enrolled in this study. The study will consist of up to 14-days screening period, 24 weeks treatment period. Approximately 312 patients will be randomized into either Test arm or Comparator arm. Patients will receive either Hetero Semaglutide Injection or Reference Injection of 0.25 mg, 0.5 mg, 1mg and 2 mg dose will be administer Subcutaneously in the abdomen, thigh, or upper arm once weekly, on the same day each week, at any time of day, with or without meals with initial Starting dose of 0.25 mg once weekly for 4 weeks and followed by Dose Titration. 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), hypoglycaemic episodes, 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. Patients will continue to receive metformin as per pre study dose for entire study duration of 24 weeks.

 
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