A clinical study to evaluate the efficacy, safety & tolerability of Semaglutide oral tablets in patients with Inadequately Controlled Type 2 Diabetes Mellitus.

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2025/06/088110
• Lead Sponsor: Dr. Reddy’s Laboratories Ltd.

Brief Summary

This isa Randomized, Multicentric, Double-Blind, Active-Controlled, Parallel Group Studyto Evaluate Efficacy, Safety and Tolerability of Oral Semaglutide Tablets ofDr. Reddy’s Laboratories Ltd Compared with RYBELSUS (Semaglutide) Tablets inAdult Patients with Inadequately Controlled Type 2 Diabetes Mellitus Phase IIIstudy.

 Thepurpose of this study is to determine the long-term safety, tolerability, andefficacy of Semaglutide in subjects with Inadequately Controlled Type 2Diabetes Mellitus.

 The study will be conducted atmultiple study centres across India. 24-week treatment duration is expected tobe adequate to assess the response to treatment. An active comparator(Rybelsus® [Semaglutide] tablets) is included to provide a control forcomparison of the safety and efficacy of Semaglutide oral tablets of Dr.Reddy’s Laboratories Ltd.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-06
• Study Start: 2025-06-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• 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.

Exclusion Criteria

• Subjects must meet NONE of the following exclusion criteria to be enrolled.
• Known or suspected hypersensitivity to investigational product(s) or related products.
• Subjects with a history of Type 1 diabetes mellitus or secondary diabetes mellitus.
• Subjects with a history of metabolic acidosis or diabetic ketoacidosis.
• Subjects with Fasting Plasma Glucose (FPG) 270 mg/dL at screening.
• 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.).
• Subjects with uncontrolled hypertension with sitting systolic BP 160 mmHg and/or diastolic BP 100 mmHg at screening.
• 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.
• 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.
• Screening serum calcitonin concentration value 100 pg/mL 11.
• History or presence of pancreatitis (acute or chronic).
• Subject has undergone bariatric surgery within 12 months prior to screening.
• 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.
• 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).
• Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
• 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).
• Subjects with alanine aminotransferase (ALT) and AST 2.5 x upper limit of the normal (ULN).
• Subjects with uncontrolled and potentially unstable diabetic retinopathy (proliferative) or maculopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1.To record mean change in HbA1c from baseline.	2.Mean change in weight from baseline .

Trial Locations

Locations (25)

Abhayahasta Multispeciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Banu Hospital - A Unit of PCRI Hospitals Pvt Ltd; 🇮🇳 Nellore, ANDHRA PRADESH, India

Chellaram Diabetes Institute; 🇮🇳 Pune, MAHARASHTRA, India

Cordis Criticare Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Datta Meghe Medical College and Shalinitai Meghe Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

DEC - Health Care Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Diacon Hospital Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Geetanjali Medical College and Hospital; 🇮🇳 Udaipur, RAJASTHAN, India

Government medical college and government general hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Horizon Lifeline Private Limited; 🇮🇳 Kolkata, WEST BENGAL, India

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Abhayahasta Multispeciality Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Sagorika Mallick

Principal investigator

9845208292

sagorika.mullick@gmail.com