Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes

Sponsor
Bahria University
Study ID
NCT07452913
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

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

Interventions

Study Details

This clinical trial aims to evaluate and compare the comparative efficacy and safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 110 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves two groups, subjects will receive the following treatments: Group A will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, whereas Group B will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) 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, 2026
Status verified
Feb 2026
Primary completion
Mar 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin + Empagliflozin (FDC)+ Sitagliptin
    Metformin decrease hepatic production of glucose. Empagliflozin increase urinary glucose excretion. Sitagliptin increase glucose dependent insulin release.
  • Active Comparator: Metformin + Empagliflozin + Linagliptin
    Metformin reduces hepatic glucose production. Empagliflozin raise excretion of urinary glucose. Sitagliptin increase glucose dependent insulin release.

Primary Outcome Measure

Primary Outcome [ Time Frame: 3 Months ]

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