CTRI/2024/10/074715 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On:
16/04/2025
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 Study to Evaluate the Efficacy, Safety of two forms/formulations of Semaglutide in Subjects with Type 2 Diabetes Mellitus.
Scientific Title of Study
A Randomized, Multicentric, Open Label, Active-Controlled, Parallel-Group, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Semaglutide Injection of Dr. Reddy’s Laboratories Pvt. Ltd Compared with Ozempic® (Semaglutide) Injection Novo Nordisk A/S, in Subjects with Type 2 Diabetes Mellitus
DRL-IND-NDA23-SEM/2024, version 2.1 dated 24 Sep 2024
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 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 Khawja Metro Station, Faridabad -121003, Haryana, India
Faridabad HARYANA 121003 India
Phone
09771407484
Fax
0129-6613520
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 Khawja Metro Station, Faridabad -121003, Haryana, India
Faridabad HARYANA 121003 India
Phone
8800799887
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 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 Khawja Metro Station, Faridabad -121003, Haryana, India
Faridabad HARYANA 121003 India
Phone
09771407484
Fax
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Dr. Reddys Laboratories Limited, 8¬2-337, Road No.3 Banjara Hills, Telangana (India) -500034
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
Mysore Medical College and Research Institute Mysore Medical College and Research Institute Irwin Road Mysuru Mysuru (Mysore) Karnataka - 570001 India
Approved
Osmania Medical College Osmania Medical College,Koti, Hyderabad,500095 Osmania Medical College, koti, Hyderabad, 500095 Hyderabad Hyderabad Telangana - 500095 India
Shah Lifeline Hospital and Heart Institute Ethics Committee
Approved
St Theresas Hospital Sanathnagar, Opp. Erragadda Raitu Bazar Hyderabad, Telangana - 500018 India
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 Novo Nordisk A/S, in Patients with Type 2 Diabetes Mellitus.
The purpose of the present trial is to compare Semaglutide injection of Dr. Reddy’s Laboratories Pvt. Ltd with Ozempic® (Semaglutide) Injection (subcutaneous) of Novo Nordisk A/S, in terms of glycaemic control, weight loss, and other efficacy and safety parameters in subjects with T2DM.
Intervention
Semaglutide
This is a A Randomized, Multicentric, Open Label, Active-Controlled, Parallel Group, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Semaglutide Injection of Dr. Reddy’s Laboratories Pvt. Ltd Compared with Ozempic® (Semaglutide) Injection Novo Nordisk A/S, in Patients with Type 2 Diabetes Mellitus.
The purpose of the present trial is to compare Semaglutide injection of Dr. Reddy’s Laboratories Pvt. Ltd with Ozempic® (Semaglutide) Injection (subcutaneous) of Novo Nordisk A/S, in terms of glycaemic control, weight loss, and other efficacy and safety parameters in subjects with T2DM.
The study will be conducted at multiple study centres across India.
Dose 0.25 mg,0.5mg, 1.0mg and 2.0 mg / Once a week
Route of administration -Subcutaneous
total duration: Six Months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subjects will be enrolled in the study if they meet all the following criteria.
1.Adult human subjects aged between 18 to 65 years (both inclusive) with diagnosis of type 2 diabetes mellitus.
2.Subjects with glycosylated haemoglobin (HbA1c) levels of 7.0% to 10.5% (both inclusive)
Subjects on stable dose of Metformin ≥1500 mg within 12 weeks of Screening Visit
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:
a) Female Condom with Spermicide or Diaphragm
b) Contraceptive subdermal implant that meets effectiveness criteria including a less than 1% rate of failure per year, as stated in the product label.
c)Intrauterine device or intrauterine hormonal system that meets effectiveness criteria including a less than 1% rate of failure per year, as stated in the product label
d) Combined oral contraceptive.
e) Injectable progestogen
f)Contraceptive vaginal ring.
5. Willing to provide written informed consent, as applicable, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF); written informed consent will be obtained prior to any study related procedures
ExclusionCriteria
Details
Subjects will not be entered into the study only if they meet any of the following criteria.
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 or diabetes insipidus.
3. Subjects with a history of metabolic acidosis or diabetic ketoacidosis.
4. Subjects with Fasting Plasma Glucose (FPG) more than 270 mg/dL at screening.
5. Subjects with the Body Mass Index (BMI) more than or equal 45.0 kg/m2 at screening.
6. Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness.
7. Subjects with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
8. 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.
9. Female who is pregnant, breast-feeding or intends to become pregnant during the study.
10. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.
11. Screening serum calcitonin value that is out of range as per central laboratory’s reference range
12. History or presence of pancreatitis (acute or chronic).
13. Subject has undergone bariatric surgery within 12 months prior to screening
14. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina
or transient ischemic attack within 180 days prior to the day of Screening Visit.
15. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
16. Planned coronary, carotid or peripheral artery revascularization known on the day of Screening Visit.
17. Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
18. Subjects with alanine aminotransferase (ALT) and AST greater than 2.5 x upper limit of the normal (ULN).
19. Subjects with uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
To determine the subject’s eligibility at Screening and Baseline, a single repeat of tests or procedures may be allowed at the discretion of the Investigator, the Medical Monitor should be consulted if needed.
Method of Generating Random Sequence
Other
Method of Concealment
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To record Mean change in HbA1c from baseline
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 .
The timepoints for secondary outcomes will be week 12 and week 24.
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"
This is a A Randomized, Multicentric, Open Label, Active-Controlled, Parallel Group, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Semaglutide Injection of Dr. Reddy’s Laboratories Pvt. Ltd Compared with Ozempic® (Semaglutide) Injection Novo Nordisk A/S, in Patients with Type 2 Diabetes Mellitus.
The purpose of the present trial is to compare Semaglutide injection of Dr. Reddy’s Laboratories Pvt. Ltd with Ozempic® (Semaglutide) Injection (subcutaneous) of Novo Nordisk A/S, in terms of glycemic control, weight loss, and other efficacy and safety parameters in subjects with T2DM.
The study will be conducted at multiple study centers across India.