Trials Sponsors Conditions Drugs Pricing

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 mgDrug

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

MetforminDrug

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

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Seoul National University Bundang Hospital
Otherlead

Study Sites (1)

SNUBH

Seongnam, South Korea

RECRUITING

Soo Lim, MD.CONTACT82-10-9766-2706 limsoo@snu.ac.kr

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

empagliflozinMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic 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

Actual (reported)

Primary Completion

September 30, 2025

Estimated (date passed)

The EMPA-FIT Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Standard

Experimental

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Standard

Experimental

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations