CTRI/2025/10/096183 [Registered on: 17/10/2025] Trial Registered Prospectively
Last Modified On:
30/04/2026
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 Study to assess Change in HbA1C levels and blood glucose levels and safety of Alkems Semaglutide Tablet compared to Rybelsus (Novo-nordisk semaglutide Tablet) in Type 2 Diabetes Mellitus after 24 weeks
Scientific Title of Study
A Phase 3 multicenter randomized double blind double dummy parallel group study to compare the efficacy and safety of Alkem Tab Semaglutide versus innovator Semaglutide (Tab Rybelsus Novo Nordisk) in patients with Type 2 Diabetes Mellitus inadequately controlled on metformin
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akhilesh Sharma
Designation
President & CMO
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya center Senapati Bapat Marg Lower Parel Mumbai MAHARASHTRA 400013 India Mumbai (Suburban)
Mumbai (Suburban) MAHARASHTRA 400013 India
Phone
9701346369
Fax
Email
akhilesh.sharma@alkem.com
Details of Contact Person Scientific Query
Name
Dr Mayur Mayabhate
Designation
Deputy General Manger
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya center Senapati Bapat Marg Lower Parel Mumbai MAHARASHTRA 400013 India Mumbai (Suburban)
Mumbai (Suburban) MAHARASHTRA 400013 India
Phone
7718808088
Fax
Email
mayur.mayabhate@alkem.com
Details of Contact Person Public Query
Name
Mr Mukesh Jaiswal
Designation
Manager-Clinical Research
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya center Senapati Bapat Marg Lower Parel Mumbai MAHARASHTRA 400013 India Mumbai (Suburban)
Room No. 01, Ground Floor Post Graduate Department of Medicine Division Medicine, G.S.V.M. Medical College,
Swaroop Nagar, Kanpur-208002, U.P, India Kanpur Nagar UTTAR PRADESH
8440331045
drrichagiri.gsvm@gmail.com
Dr V P Jyotsna
AIl India Institute of Medical Sciences, New Delhi
AIl India Institute of Medical Sciences, Room No. 305, 3rd Noor, Biotechnology Building. AlIMS, Ansari Nagar, New Delhi- 110019 New Delhi DELHI
8076713020
vivekapjyotsna@gmail.com
Dr Vipul Khandelwal
Apex Hospital Pvt Ltd, Jaipur
Room No 1, Basement OPD Floor Internal Medicine Department Main Building Apex Hospital, SP 4 & 6 MIA, Malviya Nagar, Jaipur-302017 Jaipur RAJASTHAN
9829193517
khandelwalvipul03@gmail.com
Dr Gayatri Ghanekar
Asian Institute of Medical Sciences, Dombivli
OPD No. 06, Ground Floor Asian Institute of Medical Sciences, P/72, Milap Nagar, MIDC, Dombivli [E]-421203 Mumbai MAHARASHTRA
9167531680
drgayatrighanekar@gmail.com
Dr Paramesh Shamanna
Bangalore Diabetic Centre, Bangalore
Basement Floor Research Department No. 426, 4th Cross, 2nd Block, Kalyan Nagar, Bangalore-560043 Bangalore KARNATAKA
9845010610
drparamesh2@gmail.com
Dr Unnikrishnan
Chellaram Diabetes Institute, Pune
1st floor, Chellaram Diabetes Institute, Lalani Quantum, Pune-Bangalore NH-4, Bavdhan (Budruk), Pune - 411021, Maharashtra, India. Pune MAHARASHTRA
9689287337
uagcdi@cdi.org.in
Dr Jayashree Shembalkar
Getwell Hospital And Research Institue, Nagpur
Room No 13, Ground Floor General OPD Department Getwell Hospital And Research Institue, 20/1, Dr. Khare Marg, Dhantoli, Nagpur-440012 Nagpur MAHARASHTRA
9881015523
drshembalkar@gmail.com
Dr Gandhi Parise
Government Siddhartha Medical College, Vijayawada
1st Floor, Clinical Research Department, Division Central Diagnostic Block, Government Siddhartha Medical College Ring Road, Gunadala, Vijaywada-520008, Andhra Pradesh Krishna ANDHRA PRADESH
9492732771
parisegandhi34@gmail.com
Dr K Sudheer
Great Eastern Medical School & Hospital
Department of General Medicine, Great Eastern Medical School & Hospital, Ragolu, Srikakulam- 532484, Andhra Pradesh, India. Srikakulam ANDHRA PRADESH
9666123122
drsudheerresearch@gmail.com
Dr Parag Shah
Gujarat Endocrine Centre
Gujarat Endocrine Centre, AWS 3518-526, Block-B, Opposite Manav Mandir, Nera Helmet Cross Roads, Memnagar, Ahmedabad-380052, Gujarat, India. Ahmadabad GUJARAT
9824042688
paragendo@gmail.com
Dr Aruna Mangipudi
King George Hospital, Vishakhapatnam
Department of Endocrinology, King George Hospital, Maharanipeta, Vishakhapatnam, Andhra Pradesh- 530002 Visakhapatnam ANDHRA PRADESH
9440105711
drarunamangipudiresearch@gmail.com
Dr Nitin D Karnik
Lokmanya Tilak Munciple Medical college & General hospital, SION. Mumbai
Lokmanya Tilak Munciple Medical college & General hospital, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai - 400022 Mumbai MAHARASHTRA
9821483404
drndkarnik@hotmail.com
Dr Raja Bhattacharya
Medical College & Hospital, Kolkata
Room No. 301, 2nd Floor, Division OPD Building Medicine Department, MCH Building, 4th Floor, 88 college street, Kolkata- 700073 Kolkata WEST BENGAL
8100273048
rbrbhattacharya@gmail.com
Dr Beatrice Anne
Nizams Institute of Medical Sciences, Hyderabad
Department of Endocrinology, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad- 500082, Telangana, India. Hyderabad TELANGANA
9666123122
drsudheerresearch@gmail.com
Dr Ashu Rastogi
PGIMER, Chandigarh
Room No. 16, Ground Floor Endocrinology Department Division Nehru Extension Block, Department of Endocrinology and Metabolism, PGIMER Chandigarh, Sector-12 CHD 160012 Chandigarh CHANDIGARH
9781001046
ashuendo@gmail.com
Dr Jasminder Singh
PGIMS Rohtak
Room No.4, Ground Floor, Division- Unit 4, Department of Medicine, Pt B.D.S PGIMS, Rohtak, Haryana- 124001 Rohtak HARYANA
9813140750
jasminder.singh20@gmail.com
Dr Sambit Das
Pradyumna Bal Memorial Hospital (KIMS Hospital)
Pradyumna Bal Memorial Hospital Krushna Bhadra Campus (KIIT Campus-5), Patia, Bhubaneswar- 751024, Odisha, India. Khordha ORISSA
8093060177
drsambitendocrine@gmail.com
Dr Santosh Saklecha
Santosh Hospital, Bangalore
Room No 310 3rd Floor Clinical Research Department Santosh Hospital, 6/ 1, Promenade Rd, Near Coles park, Frazer Town, Bengaluru, Karnataka 560005 Bangalore KARNATAKA
9845306703
ssaklecha@gmail.com
Dr Arindam Naskar
School of Tropical Medicine, Kolkata
Room No. 16, 3rd Floor, Division Administrative Building, Department of Endocrinology Nutrition and Metabolic Diseases, OPD Building, Govt of West Bengal, 108 Chittranjan Avenue Calcutta- 700073, Kolkata Kolkata WEST BENGAL
Department of Endocrinology, Room No. 43A, Fourth Floor, Dhanvantari OPD Block, SMS Hospital Jaipur-302004 Jaipur RAJASTHAN
9660226666
drbalramendo@gmail.com
Dr Indraneel Basu
Swami Harshankaranand Ji Hospital and Research Centre
Swami Harshankaranand Ji Hospital and Research Centre, N. 8/237 Newada, B.H.U – D.L.W. Road, Newada, Sunderpur, Varanasi- 221004 Varanasi UTTAR PRADESH
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Alkem Semaglutide Tablets (3mg, 7 mg and 14 mg)
To be taken at least 30 minutes before the first food beverage or other oral medications of the day with up to 120 ml of plain water only Swallow tablets whole Do not cut crush or chew tablets
Comparator Agent
Innovator Semaglutide Tablets (Rybelsus 3mg 7 mg and 14 mg)
To be taken at least 30 minutes before the first food beverage or other oral medications of the day with up to 120 ml of plain water only Swallow tablets whole Do not cut crush or chew tablets
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
The patients will be included in the study based on the following criteria:
1. Willing to provide voluntary written informed consent and able to comply with the protocol requirements
2. Male or female patients with Type 2 DM of 18 to 65 years of age (both inclusive)
3. Patients who have inadequate glycemic control with at least 1000 mg/ day of metformin for 8 weeks
4. Patients with HbA1c value between 7% - 10%
ExclusionCriteria
Details
The patients will be excluded from the study based on the following criteria:
1. Known hypersensitivity to Semaglutide or to any of the excipients of the investigational products
2. Patients with BMI more than equal to 40 kg/m2
3. Laboratory findings measured at screening:
a. Hemoglobin less than 10 g/dl
b. Neutrophils less than 2000/mm3
c. Platelets less than 100,000/mm3
d. Total bilirubin more than 1.5 X ULN
e. ALT/ AST more than 2.5 X ULN
f. Serum amylase and/or lipase more than 3 X ULN
g. Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study
4. Patients with Type 1 DM
5. Acute decompensation of glycemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
6. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
7. History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
8. Sr. Calcitonin at screening above or equal to 50 ng/L
9. Patients with history of diabetic retinopathy
10. Currently planned coronary, carotid or peripheral artery revascularization
11. Chronic heart failure New York Heart Association (NYHA) class III & IV
12. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
13. Personal history of non-familial medullary thyroid carcinoma
14. Presence or history of malignant neoplasm within 5 years prior to the day of screening
15. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
16. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
17. Patients with hypothyroidism or hyperthyroidism including patient on controlled thyroid function test on medications
18. Patients who are on dialysis
19. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.)
20. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents
21. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period.
22. Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack within past 3 months
23. Patients with history of pancreatitis
24. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology
25. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study. (Patient using oral contraceptives or likely to use oral contraceptive during the study will not be eligible to participate in the study)
26. Pregnant or lactating women
27. Patients with clinically significant medical history, vital signs, physical examination requiring exclusion of the patient as deemed by the investigator or designee
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Change in HbA1c levels from baseline to Week 24
Baseline to Week 24
Secondary Outcome
Outcome
TimePoints
Change in body weight from baseline to Week 24
Change in fasting plasma glucose (FPG) from baseline to Week 24
Change in post-prandial blood glucose (PPG) levels from baseline to Week 24
Percentage of patients requiring dose escalation to 14 mg/day post week 16
Baseline to Week 24
Target Sample Size
Total Sample Size="232" Sample Size from India="232" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A Phase 3 multicenter randomized double blind double dummy parallel group study to compare the efficacy and safety of Alkem Tab Semaglutide versus innovator Semaglutide (Tab Rybelsus Novo Nordisk) in patients with Type 2 Diabetes Mellitus inadequately controlled on metformin
A total 232 patients who meet the eligibility criteria will be randomized in the ratio of 1:1 to receive either test product or reference product for 24 weeks.
The total study duration will be approximately 13 months considering screening period of 2 weeks, about 6 months of recruitment period and 24 weeks of study period.
Screening Period: Up to 2 weeks
Treatment Period: It will last for 24 weeks
End of study (EOS) assessment: EOS assessment will be performed at Week 24
The primary and secondary endpoint of this trial are as follow:
Primary efficacy endpoint:
Change in HbA1c levels from baseline to Week 24
Secondary efficacy endpoint(s):
Change in body weight from baseline to Week 24
Change in fasting plasma glucose (FPG) from baseline to Week 24
Change in post-prandial blood glucose (PPG) levels from baseline to Week 24
Percentage of patients requiring dose escalation to 14 mg/day post week 16
Safety endpoints:
Treatment emergent serious and non-serious adverse events (AEs) during the study
Alteration in clinical laboratory parameters during the study (hematology, biochemistry including Sr. Calcitonin)