The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus

Summary

The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes. As the primary outcome, the investigators selected the change in skeletal muscle oxidative capacity and posed the following scientific question: Does empagliflozin significantly improve the oxidative capacity of skeletal muscle? The study will enroll 54 individuals with type 2 diabetes in a prospective, randomized, interventional, open-label study. Participants will be randomized into 3 equally sized groups: 1) a group receiving empagliflozin; 2) a group receiving metformin; and 3) a group receiving a combination of both drugs (empagliflozin and metformin). The investigators will analyze the clinical variables of the subjects, near-infrared spectroscopy (NIRS) measurements over the flexor digitorum superficialis muscle of the non-dominant arm at rest, after submaximal muscular work, and during transient brachial artery occlusion at specified time intervals (14 days, 1 month, 3 months, 6 months), as well as body composition, physical performance, and glycemic control following the pharmacological intervention.

Conditions

• Diabetes Type 2

Interventions

DRUG

Empagliflozin (Jardiance®)

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor administered orally at a standard therapeutic dose for the treatment of type 2 diabetes mellitus. In this study, empagliflozin will be administered alone (Arm 1) or in combination with metformin (Arm 3) for 6 months, with skeletal muscle oxidative capacity and microvascular reactivity assessed at baseline and follow-up visits.

DRUG

Metformin

Metformin is a biguanide antihyperglycemic agent administered orally at a standard therapeutic dose for the treatment of type 2 diabetes mellitus. In this study, metformin will be administered alone (Arm 2) or in combination with empagliflozin (Arm 3) for 6 months, with skeletal muscle oxidative capacity and microvascular reactivity assessed at baseline and follow-up visits.

COMBINATION_PRODUCT

Synjardy® 12.5mg/1000mg film-coated tablets

Fixed-dose combination product containing empagliflozin and metformin, administered orally at standard therapeutic doses for the treatment of type 2 diabetes mellitus. Used in the combination therapy arm (Arm 3) for 6 months, with skeletal muscle oxidative capacity and microvascular reactivity assessed at baseline and follow-up visits.

Sponsors & Collaborators

• University of Ljubljana, Faculty of Medicine

  collaborator OTHER

• University Medical Centre Ljubljana

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-16

Primary Completion

2027-12-31

Completion

2028-07-31

Countries

• Slovenia

Study Locations