Can a diabetes drug rev up muscle power?

NCT ID NCT07771010

Disease control Sponsor: University Medical Centre Ljubljana Source: ClinicalTrials.gov ↗

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial asks whether empagliflozin, metformin, or a combination of both can improve how muscles produce energy and respond to blood flow in people newly diagnosed with type 2 diabetes. About 54 men with type 2 diabetes will be randomly assigned to one of three groups: empagliflozin alone, metformin alone, or both drugs together. Over six months, researchers will use a non-invasive light-based technique to measure muscle oxygen recovery and blood vessel reactivity, alongside body composition and blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: empagliflozin and metformin, alone or in combination
What this could lead to: If empagliflozin improves muscle energy use, it could point to a better way to protect muscle function in people with type 2 diabetes.
What could go wrong: This is a small, early-stage study, and results may not apply to everyone. The drugs may not show a clear benefit on muscle health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Can a diabetes drug rev up muscle power?

What the study statuses mean