Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Empagliflozin (Jardiance®) for Diabetes Type 2

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?

Official registry: https://clinicaltrials.gov/study/NCT07771010 · University Medical Centre Ljubljana · enrollment listed as 54

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Empagliflozin (Jardiance®), Metformin, or Synjardy® 12.5mg/1000mg film-coated tablets. The registry lists allocation as randomized. 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.

They plan to enroll about 54 people at Ljubljana. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Empagliflozin (Jardiance®), Metformin, Synjardy® 12.5mg/1000mg film-coated tablets

Primary outcome (registry wording): Change in skeletal muscle mitochondrial oxidative capacity

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Men only
  • Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment
  • Body mass index (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

Public study contact (from the registry)

Eva Podbregar Kolar, MD

+38640762768

evapodbregar@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07771010 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07771010?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07771010?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary