Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: 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 tha
Sponsors
Dr. Reddy s Laboratories Ltd.
Eligibility
Inclusion criteria
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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 mellitusTimepoint: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: week 12 and week 24 | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia pacific Private Limit
Outcome results
None listed