Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Alkem s Semaglutide 0.25 mg, 0.5mg, 1 mg, 2mg: Test product will be administered once weekly at anytime of day, with or without meals for 24 weeks.
Control Intervention1: Innovator Sema
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 = 40 Kg/m2. 3. Laboratory findings measured at screening: a. eGFR less than 45 mL/min/1.73 m2 by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation. b. Hemoglobin less than 10 g per dl c. Neutrophils less than 2000/mm3 d. Platelets less than 100,000/mm3 e. Total bilirubin more than 1.5 X ULN f. ALT/ AST more than 2.5 X ULN g. Serum amylase and/or lipase more than 3 X ULN h. Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study 4. Patients with Type 1 DM 5. Acute decompensation of glyceamic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening 6. Sr. Calcitonin at screening above or equal to 50 ng/L 7. Patients with history of diabetic retinopathy 8. Currently planned coronary, carotid or peripheral artery revascularization 9. Chronic heart failure New York Heart Association (NYHA) class III & IV 10. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma 11. Personal history of non-familial medullary thyroid carcinoma 12. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening 13. Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening 14. Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness 15. Patients with hypothyroidism or hyperthyroidism including patient on controlled thyroid function test on medications 16. Patients who are on dialysis 17. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.) 18. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents 19. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period. 20. Any weight loss medications within 3 months prior to randomization 21. Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack within past 3 months. 22. Patients with history of pancreatitis 23. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology 24. 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 the study will not be eligible to participate in the study) 25. Pregnant or lactating women 26. Patients with clinically significant medical history, vital signs, physical examination requiring exclus
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. Proportion of patients achieving HbA1c less than 7.0% from baseline to week 24 Proportion of patients with anti-drug antibodies (ADA) & neutralizing antibody from baseline to week 24.Timepoint: from baseline to Week24 | — |
Countries
India
Contacts
Public ContactMr Mukesh Jaiswal
Alkem Laboratories Limited
Outcome results
None listed