Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Slovenia
UMC Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Eva Podbregar Kolar, MD
evapodbregar@gmail.com
+38640762768
Time Frame
Start Date: 2026-04-16
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 54
Treatments
Active_comparator: Empagliflozin
Participants with newly diagnosed type 2 diabetes will receive empagliflozin monotherapy for 6 months.
Active_comparator: Metformin
Participants with newly diagnosed type 2 diabetes will receive metformin monotherapy for 6 months.
Active_comparator: Empagliflozin + Metformin
Participants with newly diagnosed type 2 diabetes will receive combination therapy with empagliflozin and metformin for 6 months.
Related Therapeutic Areas
Sponsors
Collaborators: University of Ljubljana, Faculty of Medicine
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov

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