The EMPA-FIT Study (EMPA-FIT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Diabetes Mellitus, Type II
• Intervention / Treatment: Drug: Metformin; Drug: Empagliflozin 10 mg

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ji Young Byun Administrative staff, MS; Phone Number: 82-31-787-7035; Email: 65423@snubh.org

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Recruiting
    • SNUBH
    • Contact: Soo Lim, MD.; Phone Number: 82-10-9766-2706; Email: limsoo@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening.

Exclusion Criteria:

• individuals with a body mass index (BMI) <18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR <60 mL/min/1.73 m²) or end-stage renal disease (eGFR <15 mL/min/1.73 m² or on dialysis) were also excluded.

Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides >1,000 mg/dL or LDL cholesterol >250 mg/dL).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; Metformin therapy	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.
Experimental: Experimental; Empagliflozin therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean amplitude of glucose excursion (MAGE)	MAGE is a key glucose variability index that assesses the amplitude of clinically relevant glucose fluctuations and is calculated as the mean of the differences between consecutive glucose nadirs and peaks that exceed one standard deviation (SD) above or below the mean glucose level	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SD of glucose	Standard deviation of glucose obtained from continuous glucose monitoring (CGM)	24 weeks
Time in range (TIR)	Time in range obtained from continuous glucose monitoring (CGM)	24 weeks
Mean Blood Glucose (MBG)	Mean Blood Glucose (MBG) obtained from continuous glucose monitoring (CGM)	24 weeks
Glucose Management Indicator (GMI)	Glucose Management Indicator (GMI) obtained from continuous glucose monitoring (CGM)	24 weeks
Coefficient of Variation (CV)	Coefficient of Variation (CV) obtained from continuous glucose monitoring (CGM)	24 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Metformin, empagliflozin, glucose variability
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin; Metformin
• Other Study ID Numbers: B-2201-732-003; 2021-02251 (Other Grant/Funding Number: BI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anthropometric and biochemical data.
• IPD Sharing Time Frame: 1 year.
• IPD Sharing Access Criteria: Soo Lim
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No