Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes

Sponsor
Bahria University
Study ID
NCT06759922
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Tab Metformin + Tab Glimepiride — DRUG
    Tab Metformin 500mg+ Tab Glimepiride 2mg (FDC) once per orally for 90 days.
  • Tab Metformin + Tab Empagliflozin — DRUG
    Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) once per orally for 90 days.
  • Tab Metformin +Tab Sitagliptin — DRUG
    Tab Metformin 500mg+Tab Sitagliptin 50mg (FDC) once per orally for 90 days.
  • Tab Metformin + Tab Empagliflozin + Tab Sitagliptin — DRUG
    Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg once per orally for 90 days.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Apr 2026
Primary completion
Mar 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A: Metformin + Glimepiride (Combination Therapy)
    Dual therapy (Fixed Dose Combination): Tab Metformin 500mg + Tab Glimepiride 2mg Dosage: One tablet per day for 90 days.
  • Active Comparator: Group B: Metformin + Empagliflozin (Combination Therapy)
    Dual therapy (Fixed Dose Combination): Tab Metformin 500mg + Tab Empagliflozin 12.5mg Dosage: One tablet per day for 90 days.
  • Active Comparator: Group C: Metformin + Sitagliptin (Combination Therapy)
    Dual therapy (Fixed Dose Combination): Tab Metformin 500mg + Tab Sitagliptin 50mg Dosage: One tablet per day for 90 days.
  • Active Comparator: Group D: Metformin + Empagliflozin + Sitagliptin (Combination Therapy)
    Triple Therapy: Tab Metformin 500mg + Tab Empagliflozin 12.5mg (Fixed Dose Combination) + Tab Sitagliptin 50mg Dosage: One tablet of each per day for 90 days.

Primary Outcome Measure

Primary Outcome [ Time Frame: 3 months ]

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