Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Trelagliptin 100 mg Tablet: Once weekly for 16 weeks
Control Intervention1: Vildagliptin 50 mg Tablet: Twice daily for 16 weeks
Sponsors
Zuventus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged =18 years. 2. Naïve patients diagnosed with Type 2 diabetes mellitus. 3. Patients with glycosylated hemoglobin (HbA1c) ranged in 6.5-10% (both inclusive) at screening. 4. Patients with BMI ranged from 19-35 kg/m2 (both inclusive). 5. Patients who are willing to participate voluntarily and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to Trelagliptin, Vildagliptin or any of the ingredients of the formulation. 2. History of acute or chronic liver disease, and SGOT or SGPT > 2.5 times of reference range or total bilirubin > 1.5 times of reference range during the screening period. 3. Renal insufficiency, with eGFR 4. Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma), or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy) 5. Active heart disease (including acute myocardial infarction, unstable angina), moderate to severe congestive heart failure 6. History of epilepsy, mental illness, major depression, or previous abnormal thyroid function and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease. 7. Female patients who are pregnant, lactating or not following adequate contraceptive measures. 8. Patients otherwise judged to be inappropriate for inclusion in the study by the investigator. 9. Patients with known history of pancreatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated haemoglobin (HbA1c) levels.Timepoint: Baseline and end of week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in 2-hours postprandial glucoseTimepoint: Baseline and end of week 6, 12, 16;Mean change in C-peptide levelTimepoint: Baseline and end of week 16;Mean change in fasting blood glucoseTimepoint: Baseline and end of week 6, 12, 16;Mean change in fasting glucagon levelTimepoint: Baseline and end of week 16;Mean change in fasting insulinTimepoint: Baseline and end of week 16;Mean change in GLP-1 levelsTimepoint: Baseline and end of week 16;Number of patients reporting incidences of adverse eventsTimepoint: Entire study period | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Limited
Outcome results
None listed