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

NCT06759922 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tab Metformin + Tab Glimepiride

Tab Metformin 500mg+ Tab Glimepiride 2mg (FDC) once per orally for 90 days.

DRUG

Tab Metformin + Tab Empagliflozin

Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) once per orally for 90 days.

DRUG

Tab Metformin +Tab Sitagliptin

Tab Metformin 500mg+Tab Sitagliptin 50mg (FDC) once per orally for 90 days.

DRUG

Tab Metformin + Tab Empagliflozin + Tab Sitagliptin

Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg once per orally for 90 days.

Sponsors & Collaborators

  • Bahria University

    lead OTHER

Principal Investigators

  • Saima Chandio, 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
2025-01-01
Primary Completion
2025-03-30
Completion
2025-06-30

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06759922 on ClinicalTrials.gov