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ENROLLING BY INVITATION
NCT07452913
PHASE4

Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes

Sponsor: Bahria University

View on ClinicalTrials.gov

Summary

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.

Official title: Comparative Efficacy and Safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin as Initial Triple Therapy in Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-01-01

Completion Date

2026-06-30

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

Metformin+ Empagliflozin + Sitagliptin

Group A (Triple Therapy): Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, orally, once daily for 90 days

DRUG

Metformin + Empagliflozin + Linagliptin

Group B (Triple Therapy) Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) orally, once daily, for 90 days.

Locations (1)

National Medical Center Karachi

Karachi, Sindh, Pakistan