Empagliflozin Effect on Glucose Toxicity

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized, open-label, controlled, parallel group, exploratory study.

It had two arms (groups): Empagliflozin (Jardiance®) (experimental) and Insulin Glargine (Lantus®) (active comparator).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 40 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The informed consent form must be signed before any study specific tests or procedures are done. Male or female patients aged between 40 and 70 years (including) at the first screening visit. Patients diagnosed with T2DM. Stable treatment with antidiabetic drugs over the last 4 weeks. Accepted background medication:.

The full record lists 11 inclusion and 21 exclusion criteria; among the exclusions: unstable angina pectoris, myocardial infarction or stroke within 1 year before inclusion in the study; history of atrial fibrillation; uncontrolled arterial hypertension (\> 160/100 mmhg in three subsequent measurements - mean value).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-10-27 with completion listed for 2023-05-03.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in skeletal muscle H202 concentration between baseline and end of treatment (EoT) (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example Change in skeletal muscle lipid peroxidation, Change in 24-hour urinary excretion rate of 8-iso PGF2a, • Difference in DNA methylation pattern and Change in plasma FFA levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.