The EMPA-FIT Study

NCT06846411 | Recruiting Phase 4

• 2 other identifiers: B-2201-732-0032021-02251
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metformin, empagliflozin, glucose variability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• SD of glucose

  24 weeks

• Time in range (TIR)

  24 weeks

• Mean Blood Glucose (MBG)

  24 weeks

• Glucose Management Indicator (GMI)

  24 weeks

• Coefficient of Variation (CV)

  24 weeks

Study Arms (2)

Standard

ACTIVE COMPARATOR

Metformin therapy

Drug: Metformin

Experimental

EXPERIMENTAL

Empagliflozin therapy

Drug: Empagliflozin 10 mg

Interventions

Empagliflozin 10 mg DRUG

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

Metformin DRUG

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.

Standard

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

SNUBH

Seongnam, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Ji Young Byun Administrative staff, MS

CONTACT

82-31-787-7035; 65423@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: January 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year.
• Access Criteria: Soo Lim

Locations

KR (1)