Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Alkem Semaglutide Tablets (3mg, 7 mg and 14 mg): To be taken at least 30 minutes before the first food beverage or other oral medications of the day with up to 120 ml of plain water onl
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: The patients will be included in the study based on the following criteria: 1. Willing to provide voluntary written informed consent and able to comply with the protocol requirements 2. Male or female patients with Type 2 DM of 18 to 65 years of age (both inclusive) 3. Patients who have inadequate glycemic control with at least 1000 mg/ day of metformin for 8 weeks 4. Patients with HbA1c value between 7% - 10%
Exclusion criteria
Exclusion criteria: The patients will be excluded from the study based on the following criteria: 1. Known hypersensitivity to Semaglutide or to any of the excipients of the investigational products 2. Patients with BMI more than equal to 40 kg/m2 3. Laboratory findings measured at screening: a. Hemoglobin less than 10 g/dl b. Neutrophils less than 2000/mm3 c. Platelets less than 100,000/mm3 d. Total bilirubin more than 1.5 X ULN e. ALT/ AST more than 2.5 X ULN f. Serum amylase and/or lipase more than 3 X ULN g. Any other screening laboratory value that is clinically significant in the Investigatorâ??s opinion precluding patientâ??s participation in the study 4. Patients with Type 1 DM 5. Acute decompensation of glycemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening 6. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) 7. History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) 8. Sr. Calcitonin at screening above or equal to 50 ng/L 9. Patients with history of diabetic retinopathy 10. Currently planned coronary, carotid or peripheral artery revascularization 11. Chronic heart failure New York Heart Association (NYHA) class III & IV 12. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma 13. Personal history of non-familial medullary thyroid carcinoma 14. Presence or history of malignant neoplasm within 5 years prior to the day of screening 15. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening 16. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening 17. Patients with hypothyroidism or hyperthyroidism including patient on controlled thyroid function test on medications 18. Patients who are on dialysis 19. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.) 20. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents 21. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period. 22. Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack within past 3 months 23. Patients with history of pancreatitis 24. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology 25. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study. (Patient using oral contraceptives or likely to use oral contraceptive during t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels from baseline to Week 24Timepoint: Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to Week 24 Change in fasting plasma glucose (FPG) from baseline to Week 24 Change in post-prandial blood glucose (PPG) levels from baseline to Week 24 Percentage of patients requiring dose escalation to 14 mg/day post week 16Timepoint: Baseline to Week 24 | — |
Countries
India
Contacts
Public ContactMr Mukesh Jaiswal
Alkem Laboratories Limited
Outcome results
None listed