Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Metformin + Trelagliptin (100 mg once weekly): Metformin (500 mg twice daily, oral administration) and Trelagliptin (100 mg once weekly, oral administration)
Control Intervention1: Metf
Sponsors
Prafulla Chandra Sen Govt Medical College
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with a confirmed diagnosis of Type 2 Diabetes Mellitus, having HbA1c levels between 6.5 and 10.5 , and currently receiving stable doses of Metformin and Glimepiride for at least 8 weeks prior to enrolment, with fasting plasma glucose (FPG) more than or equal to 126 mg/dL and postprandial plasma glucose (PPG) more than or equal to 200 mg/dL at screening.
Exclusion criteria
Exclusion criteria: Patients with prior exposure to any Sulfonyl urea DPP-4 inhibitor or sodium glucose cotransporter-2 (SGLT2) inhibitor are excluded. Additional exclusions include a diagnosis of Type 1 Diabetes Mellitus, renal impairment, active hepatic disease, or any other medical condition that, in the investigator s opinion, may interfere with study participation or outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in Glycosylated Hemoglobin (HbA1c) from baseline to 3 and 6 months between the triple therapy arm (Trelagliptin + Glimepiride + Metformin) and the dual therapy arm (Glimepiride + Metformin).Timepoint: Baseline 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate glycemic variability using Fasting Blood Glucose (FBG), Post Prandial Blood Glucose (PPBG), and Continuous Glucose Monitoring (CGM)Timepoint: Baseline 3 Months | — |
Countries
India
Contacts
Public ContactDR RUDRA PAUL
Prafulla Chandra Sen Govt Medical College
Outcome results
None listed