Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes
NCT07452913 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2026-03-05
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.
Conditions
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.
Sponsors & Collaborators
-
Bahria University
lead OTHER
Principal Investigators
-
Khalil Ur Rehman, MBBS · Bahria University, Islamabad
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-03-30
- Completion
- 2026-06-30
Countries
- Pakistan
Study Locations
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