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