NCT06846411

The EMPA-FIT Study

Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.

Conditions

• Diabetes
• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 mg	The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin.
DRUG	Metformin	The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

1 site across 1 country: South Korea