CTRI/2025/06/088110 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On:
03/06/2025
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 clinical study to evaluate the efficacy, safety & tolerability of Semaglutide oral tablets in patients with Inadequately Controlled Type 2 Diabetes Mellitus.
Scientific Title of Study
A Randomized, Multicentric, Double-Blind, Active-Controlled, Parallel Group, Phase III Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Oral Semaglutide Tablets of Dr. Reddy’s Laboratories Ltd Compared with RYBELSUS (Semaglutide) Tablets in Adult Patients with Inadequately Controlled Type 2 Diabetes Mellitus
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
DRL-IND-NDA28-SEM/2024 Version 2.0 dated 12 Feb 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jayashri Krishnan
Designation
Vice President Operations
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Plot no 12/4, Sector 27 D,
Delhi Mathura Road, Near Sarai Khawaja Metro Station
Faridabad HARYANA 121003 India
Phone
9771407484
Fax
Email
jayashri.krishnan@jssresearch.com
Details of Contact Person Scientific Query
Name
Dr Sonika Newar
Designation
General Manager- Medical Monitoring and Safety
Affiliation
JSS Medical Research Asia pacific Private Limit
Address
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Plot no 12/4, Sector 27 D,
Delhi Mathura Road, Near Sarai Khawaja Metro Station
Faridabad HARYANA 121003 India
Phone
08800799887
Fax
Email
Sonika.newar@jssresearch.com
Details of Contact Person Public Query
Name
Dr Jayashri Krishnan
Designation
Vice President Operations
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Plot no 12/4, Sector 27 D,
Delhi Mathura Road, Near Sarai Khawaja Metro Station Tower 2, 1st Floor, South Wing, L&T Business Park, Faridabad HARYANA 121003 India
Phone
09771407484
Fax
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Dr. Reddy’s Laboratories Ltd.
Integrated Product Development Organization,
Innovation plaza, Survey No: 42, 45 and 46,
Bachupally village, Bachupally Mandal
Medchal Malkajgiri District 500 090,
Telangana, India
Primary Sponsor
Name
Dr. Reddy’s Laboratories Ltd.
Address
Integrated Product Development Organization, Innovation plaza, Survey No: 42, 45 and 46, Bachupally village, Bachupally Mandal Medchal Malkajgiri District 500 090,Telangana, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 25
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sagorika Mallick
Abhayahasta Multispeciality Hospital
1st floor 347/247, 2nd Cross Kaggadasapura, Main road C V Raman Nagar, Bangalore, 560093, Karnataka Bangalore KARNATAKA
Government medical college and government general hospital
Dept. of Clinical Research 2nd floor Beside FM ward Government Medical College & Government General Hospital- Srikakulam 532001, Andhra Pradesh, India Srikakulam ANDHRA PRADESH
9908611119
drnarasingaraossvv@yahoo.com
Dr Utsa Basu
Horizon Lifeline Private Limited
Horizon Lifeline Private Limited- No. P34, Park Circus, CIT Road, Entally, Kolkata, West Bengal 700014 Kolkata WEST BENGAL
9432658968
dr.utsabasu@yahoo.com
Dr Anil Samaria
Jawaharlal Nehru Medical College
Jawahar Lal Nehru Medical College Kala Bagh, Ajmer, 305001 Rajasthan Ajmer RAJASTHAN
9414008246
dranilsamaria@outlook.com
Dr Sambit Das
Kalinga Institute of Medical Sciences
Kalinga Institute of Medical Sciences- Kushabhadra campus-5, KIIT Road, Bhubaneshwar, Odisha, 751024 Khordha ORISSA
Shah Lifeline Hospital and Heart Institute Ethics Committee
Approved
Shah Lifeline Hospital and Heart Institute Ethics Committee
Submittted/Under Review
Shubham Institutional 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
Rybelsus® (Semaglutide) Tablets 3mg, 7mg and 14mg
Comparator product will be administered daily at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than ~120 ml of plain water only for 24 weeks
Intervention
Semaglutide Tablets 3mg, 7mg and 14mg
Test product will be administered daily at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than ~120 ml of plain water only for 24 weeks.
Dose - 3mg, 7mg, 14mg
Frequency - Start with 3mg tablets, orally, one tablet once daily. After 4 weeks, increase the dosage to 7 mg tablets, orally, one tablet once daily. If additional glycemia control is needed, increase the dosage to 14 mg tablets, orally, one tablet once daily after at least 4 weeks on the 7 mg dose.
Route of Administration – Oral
Total duration of such intervention – The total duration of the study will be 26 weeks (2 weeks of screening period prior to randomization and 24 weeks of treatment).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Adult human subjects aged between 18 to 65 years (both inclusive) with a diagnosis of type 2 diabetes mellitus.
2. Subjects with glycosylated hemoglobin (HbA1c) levels of 7.0% to 9.5% (both inclusive).
3. Subjects, along with diet and exercise control, additionally on a stable dose of Metformin (1500 mg or maximally tolerated) either alone or in combination with SU (half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject’s medical record) or in combination with a stable daily dose of a SGLT-2 inhibitor (all doses approved as maintenance therapy) within 90 days prior to the day of screening.
4. Subjects with the Body Mass Index (BMI) of 23 - 45.0 kg/m2 (both inclusive) at screening.
5. Female subjects of child-bearing potential and male subjects who are engaging in sexual activity with female partner of child-bearing potential that could lead to pregnancy, must use at least 1 of the following adequate birth control methods while on study treatment and for 4 weeks after the last exposure to investigational product. Acceptable contraception methods include.
Male partner with vasectomy, OR
Male condom AND partner use of at least 1 of the contraceptive options below:
Female Condom with Spermicide or Diaphragm
Contraceptive subdermal implant that meets effectiveness criteria including a 1% rate of failure per year, as stated in the product label.
Intrauterine device or intrauterine hormonal system that meets effectiveness criteria including a 1% rate of failure per year, as stated in the product label.
Combined oral contraceptive.
Injectable progestogen
Contraceptive vaginal ring.
6. Willing to provide written informed consent, as applicable, which includes compliance with the requirements and re-strictions listed in the informed consent form (ICF); written informed consent will be obtained prior to any study related procedures.
ExclusionCriteria
Details
Subjects must meet NONE of the following exclusion criteria to be enrolled.
1. Known or suspected hypersensitivity to investigational product(s) or related products.
2. Subjects with a history of Type 1 diabetes mellitus or secondary diabetes mellitus.
3. Subjects with a history of metabolic acidosis or diabetic ketoacidosis.
4. Subjects with Fasting Plasma Glucose (FPG) 270 mg/dL at screening.
5. Subjects with chronic insulin treatment within the past 3 months (short term course of 7 days is allowed e.g. for infection or trauma etc.).
6. Subjects with uncontrolled hypertension with sitting systolic BP 160 mmHg and/or diastolic BP 100 mmHg at screening.
7. Subjects with any abnormality on 12-lead ECG at screening that in the opinion of the Investigator is clinically significant and is judged as potential risk for his/her participation in the study.
8. Female who is pregnant, breast-feeding or intends to become pregnant during the study.
9. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is de-fined as a first degree relative.
10. Screening serum calcitonin concentration value 100 pg/mL
11. History or presence of pancreatitis (acute or chronic).
12. Subject has undergone bariatric surgery within 12 months prior to screening.
13. Subjects with any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic at-tack within the past 180 days prior to the day of screening.
14. Subjects presently classified as being in New York Heart As-sociation (NYHA) Class IV (Symptoms of heart failure at rest. Any physical activity causes further discomfort).
15. Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
16. Renal impairment measured as estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
17. Subjects with alanine aminotransferase (ALT) and AST 2.5 x upper limit of the normal (ULN).
18. Subjects with uncontrolled and potentially unstable diabetic retinopathy (proliferative) or maculopathy
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To compare the effect of Semaglutide oral tablets of Dr. Reddy’s Laboratories Ltd, once-daily versus Rybelsus (Semaglutide) tablets once-daily, when added on to ongoing oral anti-diabetic drug therapy, on glycaemic control, in subjects with inadequately controlled type 2 diabetes mellitus
week 24
Secondary Outcome
Outcome
TimePoints
1.To record mean change in HbA1c from baseline.
2.Mean change in weight from baseline .
3. Mean change in fasting plasma glucose (FPG) from baseline.
4. Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline
5. Number of subjects achieving a therapeutic glycaemic response, defined as HbA1c less than 7% from baseline
6. Proportion of subjects requiring rescue medications from baseline
week 12 and week 24
Target Sample Size
Total Sample Size="288" Sample Size from India="288" 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)
13/06/2025
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="0" Months="9" Days="14"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
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, Multicentric, Double-Blind, Active-Controlled, Parallel Group Study
to Evaluate Efficacy, Safety and Tolerability of Oral Semaglutide Tablets of
Dr. Reddy’s Laboratories Ltd Compared with RYBELSUS (Semaglutide) Tablets in
Adult Patients with Inadequately Controlled Type 2 Diabetes Mellitus Phase III
study.
The
purpose of this study is to determine the long-term safety, tolerability, and
efficacy of Semaglutide in subjects with Inadequately Controlled Type 2
Diabetes Mellitus.
The study will be conducted at
multiple study centres across India. 24-week treatment duration is expected to
be adequate to assess the response to treatment. An active comparator
(Rybelsus® [Semaglutide] tablets) is included to provide a control for
comparison of the safety and efficacy of Semaglutide oral tablets of Dr.
Reddy’s Laboratories Ltd.