Empagliflozin and metformin and muscle function in newly diagnosed type 2 diabetes
Compares empagliflozin, metformin and both together on muscle function in new type 2 diabetes.
Plain-language title generated from the registry record
Registry title: The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus
Key facts
- Where
- Ljubljana, SloveniaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07771010, who can take part
Where in Slovenia
- UMC LjubljanaLjubljana, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Centre Ljubljana
- Trial code
- NCT07771010
- Record updated
- 18 August 2026
- Original description
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.Read full original descriptionShow less
The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus
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.
Inclusion: 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: 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; Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol/L, HbA1c ≥ 10%; 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.