NCT07771010RecruitingPhase 4
The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 16 Apr 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Type 2 diabetes
- NCT number
- NCT07771010
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 54
- From 16 Apr 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other forms of diabetes mellitus (i.e., not type 2)
- Type 2 diabetes mellitus known for more than 2 years
- 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
Lab values
- Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol/L, HbA1c ≥ 10%
Other
- 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
- Life expectancy less than 3 months
- Unwillingness to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMC Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.