This is a study to establish non-inferiority of Intas semaglutide subcutaneous injectionagainst Innovator semaglutide (Ozempic, Novo Nordisk) subcutaneous injection in adultparticipants with type 2 diabetes mellitus who are inadequately controlled on metformin, in adjunctto diet and exercise

Phase 3

Not yet recruiting

• Conditions: Endocrine, nutritional and metabolic diseases,

• Registration Number: CTRI/2025/06/089290
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

This is a study to establish non-inferiority of Intas semaglutide subcutaneous injection against Innovator semaglutide (Ozempic, Novo Nordisk) subcutaneous injection in adult participants with type 2 diabetes mellitus who are inadequately controlled on metformin, in adjunct to diet and exercise

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-07
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 1. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 as well as in this protocol and is willing to participate in the study 2) Male or female participants with age 18 to 65 in completed years (both inclusive) at the time of signing the informed consent.
• 3. Participants with type 2 diabetes mellitus having Glycosylated Haemoglobin (HbA1c) greater than or equal to 7 percentage and less than 10.5 percentage at screening assessment.
• 4. Participants along with diet and exercise control, additionally on stable daily dose of metformin (greater than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening).
• 5. Contraceptive use by participants or participant’s partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4.
• Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 2 months after the last dose of the study intervention.
• The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention.
• A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception.
• A WOCBP agrees to seek advice about donation and cryopreservation of germ cells.
• A WOCBP must have a negative highly sensitive serum Bhuman chorionic gonadotropin (BhCG) test at Screening and urine BhCG test at Baseline.
• If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
• In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
• 6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 months after the last dose of study intervention: Must agree not to plan to father a child or donate sperm for reproduction; PLUS, either of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR Must agree to use contraception barrier as detailed below a male participant must wear a condom when engaging in any activity that allows for the passage of ejaculate to another person o With female partner use of an additional highly effective contraceptive method with a failure rate of less than 1 percentage per year as described in Appendix 4 7) The participant with adequate hematologic, liver, renal function and other parameters as mentioned below, at screening assessment.
• a) Haemoglobin greater than or equal to 9 g per dL b) WBC count greater than or equal to 2500 per cu.mm c) Neutrophil count greater than or equal to 1500 per cu.mm d) Platelet count greater than or equal to 100,000 per cu.mm e) Calcitonin less than or equal to 50 ng per L f) Blood amylase less than or equal to 3 into ULN g) Blood lipase less than or equal to 3 into ULN h) Total bilirubin less than or equal to 1.5 into ULN i) Alanine aminotransferase (ALT) less than or equal to 3 into ULN j) Aspartate aminotransferase (AST) less than or equal to 3 into ULN k) Alkaline phosphatase (ALP) less than or equal to 3 into ULN l) Estimated glomerular filtration rate (eGFR) greater than 30ml per min per 1.73m2 as assessed by CKD-EPI 2021 equation.

Exclusion Criteria

• 1. Known allergies, hypersensitivity, or intolerance to any of the study interventions and other GLP-1 receptor agonists, or components excipients thereof (refer to the SmPC of Ozempic), or drug or other allergies that, in the opinion of the investigator, contraindicates participation in the study.
• 2. Participants with Fasting blood glucose greater than or equal to 270 mg per dL at screening.
• 3. Participants with Body Mass Index greater than or equal to 45 kg per m2 at screening.
• 4. Contraindications or limitations for administration of investigational intervention according to SmPC of Ozempic.
• 5. Treatment with any medication for diabetes or obesity 12 weeks or less before screening [other than metformin, or short-term insulin (less than or equal to 14 days in total).
• 6. Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention.
• 7. Positive hepatitis C antibody test result at screening or within 3 months prior to starting the investigational intervention.
• NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
• 8. Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
• 9. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• Family is defined as a first degree relative.
• 10. Participants with a documented medical history of uncontrolled, clinically significant intercurrent medical conditions that, in the investigators opinion, could affect weight and glucose metabolism.
• 11. Continuous or cumulative use of systemic glucocorticoids for more than 14 days within 3 months before screening (systemic glucocorticoids: intravenous, oral or intra articular glucocorticoid treatment).
• 12. Plan to receive glucocorticoids, immunosuppressants, or other drugs (except topical medications and inhaled preparations) that are assessed as unsuitable during the study by the investigator.
• 13. Participants with documented diagnosis of type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing syndrome or acromegaly-associated diabetes).
• 14. History or presence of malignancy within the past 5 years except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer 15) Have a history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis or hyperosmolar hyperglycaemic state) within 6 months before screening.
• 16. Participants who have undergone bariatric surgery within 12 months prior to screening.
• 17. Participant with clinically significant current or recent [within the past 90 days before randomization (unless otherwise specified below)] cardiac conditions as defined below: a) Acute coronary syndrome, stroke [including transient ischemic attack (TIA)] or other ischemic event or thromboembolic event [e.g., deep vein thrombosis (DVT), pulmonary embolism] within the past 90 days prior to randomization.
• b) Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification of Class III and IV presently.
• 18. History of proliferative retinopathy or diabetic macular oedema, or any other unstable retinopathy (rapidly progressive) recorded in medical history and may require treatment during the study.
• 19. Participants with a history of acute chronic pancreatitis.
• 20. Received any other investigational intervention or used a drug releasing invasive investigational medical device within 3 months or 5 half lives prior to the first dose of study intervention, whichever is longer, or participant is currently enrolled in an investigational study.
• 22. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
• 23. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period.
• 24. Participants with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and or diastolic BP greater than or equal to 100 mmHg at screening.
• Note: If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart.
• Participants may be re-tested or rescreened after initiation or adjustments of antihypertensive medications to establish control.
• 27. Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish non-inferiority of semaglutidetest	Change from Baseline to Week 24 in Glycosylated Haemoglobin (HbA1c)
compared to semaglutide-reference in	Change from Baseline to Week 24 in Glycosylated Haemoglobin (HbA1c)
adult participants with type 2 diabetes	Change from Baseline to Week 24 in Glycosylated Haemoglobin (HbA1c)
mellitus who are inadequately controlled on	Change from Baseline to Week 24 in Glycosylated Haemoglobin (HbA1c)
metformin, in adjunct to diet and exercise	Change from Baseline to Week 24 in Glycosylated Haemoglobin (HbA1c)

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of semaglutide-test	compared to semaglutide-reference in adult
To evaluate the safety of semaglutide-test	compared to semaglutide-reference in adult
To evaluate the immunogenicity of	semaglutide-test compared to semaglutidereference

Trial Locations

Locations (16)

B J Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Department of Endocrinology, Seth GS Medical College and KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Department of Endocrinology, SMS Medical College; 🇮🇳 Jaipur, RAJASTHAN, India

Diabetes Bhawan and multispecialty hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Endocare Clinic; 🇮🇳 Nashik, MAHARASHTRA, India

Endoliofe Speciality Hospitals; 🇮🇳 Guntur, ANDHRA PRADESH, India

G.S.V.M. Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Gujarat Endocrine Centre; 🇮🇳 Ahmadabad, GUJARAT, India

K R Hospital; 🇮🇳 Mysore, KARNATAKA, India

KIMS Hospital; 🇮🇳 Khordha, ORISSA, India

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B J Medical College & Civil Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Kartikey Parmar

Principal investigator

drkartik@gmail.com