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)
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
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.