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

ClinicalTrials.gov IDNCT07771010

PhasePHASE4

Enrollment54

SponsorUniversity Medical Centre Ljubljana

Age18 Years

SexMALE

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Conditions studied

Diabetes Type 2

About this study

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.

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.

Primary outcomes

Change in skeletal muscle mitochondrial oxidative capacity (Baseline, Day 14, Month 1, Month 3, and Month 6)

Eligibility information

Inclusion Criteria: * Male sex * Age 18-75 years * Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment * Body mass index (BMI) 25-35 kg/m² * Currently managed at a diabetes outpatient clinic * No known chronic diabetes-related complications * No prior antidiabetic pharmacological treatment, with the exception of sulfonylureas Exclusion Criteria: * Other forms of diabetes mellitus (i.e., not type 2) * Type 2 diabetes mellitus known for more than 2 years * Comorbidities known to independently affect skeletal muscle oxidative capacity, including: spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, cystic fibrosis, local joint immobility, or hemiplegia * Known mitochondrial disease * Heart failure, NYHA class II or higher * Chronic kidney disease, stage 3 or higher * Poorly controlled chronic medical conditions (e.g., arterial hypertension, hypothyroidism) * Recurrent urinary tract infections * Active malignancy currently undergoing oncologic treatment * Life expectancy less than 3 months * Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol/L, HbA1c ≥ 10% * Unwillingness to provide informed consent

Study locations

UMC Ljubljana, Ljubljana, 1000 Slovenia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.