At a glance
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Clinical Efficacy and Safety of Glimepiride, Empagliflozin and Sitagliptin With Metformin in Type 2 Diabetes Mellitus: A Double and Triple Drug Therapy
In Brief
A Phase 4 clinical trial evaluating Tab Metformin + Tab Glimepiride, Tab Metformin + Tab Empagliflozin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 172 participants across 1 site.
Detailed Summary
This clinical trial aims to evaluate and compare the clinical efficacy and safety of Glimepiride, Empagliflozin, and Sitagliptin with Metformin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 172 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves four groups, subjects will receive following treatment: Group A will receive Tab Metforrmin 500mg + Tab Glimepiride 2mg (FDC) , Group B Tab Metforrmin 500mg + Tab Empagliflozin 12.5mg (FDC), Group C Tab Metforrmin 500mg + Tab Sitagliptin 50mg (FDC) and Group D Tab Metformin 500mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg per orally, once daily for 90 days. Safety and efficacy will be assessed through anthropometric measurements and lab investigations at baseline, 6 weeks, and 12 weeks, with weekly monitoring of blood sugar levels. The total duration of the study will be 6 months, with a 3-month individual treatment period.
Study Details
Timeline
Interventions
Tab Metformin 500mg+ Tab Glimepiride 2mg (FDC) once per orally for 90 days.
Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) once per orally for 90 days.
Tab Metformin 500mg+Tab Sitagliptin 50mg (FDC) once per orally for 90 days.
Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg once per orally for 90 days.