Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Semaglutide Tablet 3 mg/7 mg/14 mg/Placebo of Semaglutide Tablet: Once a day along with respective placebo of RYBELSUS (Semaglutide) tablet for 24 weeks
Control Intervention1: RYBELSUS
Sponsors
Torrent Pharmaceuticals Ltd Torrent Research Centre
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects of 18 to 65-both inclusive years of age, at the time of signing informed consent. 2. Subject having a confirmed diagnosis of type 2 diabetes mellitus T2DM greater than and is equal to 12 weeks prior to the day of screening. 3.Subjects with inadequate glycemic control with HbA1c greater than or is equal to 7.0 per to less than or is equal to 9.5 per. 4. Subject on a stable daily dose of metformin greater than 1500 mg or maximum tolerated dose either alone or in combination with a stable daily dose of a SU (half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) or in combination with a stable daily dose of a SGLT 2 inhibitor all doses approved as maintenance therapy for at least 12 weeks prior to the day of screening. 5. Subject is willing to provide written informed consent document and have ability and willingness to adhere to the protocol.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycemia, fasting plasma glucose greater than 270 mg/dl at screening. 2. Treatment with any antidiabetic medications other than metformin, SU and SGLT-2 inhibitor within 12 weeks prior to screening. 3. Subjects who required to take insulin treatment for any acute illness within 12 weeks prior to screening. 4. Subject with BMI value less than 23 kg per m2 or greater than or is equal to 45.0 kg/m2 at screening. 5. Subjects with history or presence of hypothyroidism/ hyperthyroidism at the time of screening. 6. Treatment with weight loss medications includes but not limited to orlistat, cetilistat, topiramate, glucagon-like peptide-1 receptor agonists such as liraglutide, tirzepatide within 12 weeks prior to screening. 7. Ongoing treatment with systemic steroids other than inhaled or topical steroids at time of screening. 8.Subjects with the diagnosis of unstable [proliferative] retinopathy or maculopathy, verified on the basis of fundus examination carried out at screening. 9. Subjects with any of the following: myocardial infarction, stroke or unstable angina and/or transient ischaemic attack within 24 weeks prior to screening. 10. Subjects with New York Heart Association NYHA Class III or IV symptoms. 11. Subjects with any planned major or minor surgery or invasive procedure within the next 24 weeks from the day of screening. 12. Subject with history of any gastrointestinal surgery (except an appendicectomy performed greater than or is equal to 1 year from screening) or any chronic gastrointestinal condition. 13. Subject with renal impairment defined as estimated Glomerular Filtration Rate less than 60 mL/min/1.73 m2as evaluated by Modification of Diet in Renal Disease (MDRD) formula. 14. Subjects with serum creatinine more than upper limit of normal (ULN). 15. Subjects with liver enzymes aspartate transaminase, serum glutamic oxaloacetic transaminase, Alanine transaminase ,serum glutamic pyruvic transaminase, alkaline phosphatase more than 1.5 times of ULN or total bilirubin more than 1.5 times of ULN. 16. Subject having known allergy or hypersensitivity to GLP-1 receptor agonist (RA). 17. Subject with history of human immunodeficiency viruses (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV). 18. Subjects with personal or family history of medullary thyroid carcinoma or subjects with multiple endocrine neoplasia syndrome type 2 or serum calcitonin value greater than or is equal to 100 ng/L at screening 19. Subject with history or presence of malignant neoplasms within the last 5 years or currently receiving any anti-cancer medication. 20. Subject with history of pancreatitis (acute or chronic). 21. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and neither surgically sterilized nor willing to use reliable contraceptive methods throughout the study duration and for 8 weeks after the last exposure to investigational product. 22.Male subjects who are engaging in sexual activity with female partner of child-bearing potential and not willing to use reliable contraceptive methods throughout the study duration. 23. Any clinically significant condition that in the investigator s opinion may hinder the subject s participation in the study or can interfere with the in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of semaglutide oral tablets compared to RYBELSUS (semaglutide) oral tablets in adult patients of type 2 diabetes mellitus who are inadequately controlled on background therapy [stable dose of metformin or metformin + sodium-glucose co-transporter-2 (SGLT-2) inhibitor or metformin + sulphonylureas (SU)].Timepoint: Mean change from baseline in HbA1c at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety & further efficacy of semaglutide oral tablets compared to RYBELSUS (semaglutide) oral tablets in adult patients of type 2 diabetes mellitus who are inadequately controlled on background therapy (stable dose of metformin or metformin + SGLT-2 inhibitor or metformin + SU). Timepoint: Mean change in HbA1c from baseline to week 8,12 & 16. Mean change from baseline to week 8,12,16& week 24. Proportion of patients achieving HbA1c 7.0 % at the week 24. Proportion of patient who required rescue medication from baseline to at the end of treatment (week 24). Mean change from baseline to week 24 in fasting lipid profile. Number of treatment emergent adverse events (TEAEs). | — |
Countries
India
Contacts
Public ContactDr Prashant Jamadarkhana
Outcome results
None listed