GLP-1 Receptor Agonist Therapy and Albuminuria in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Exenatide.

This is a prospective study to evaluate effect of Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo.

It had two arms (groups): Exenatide extended release (experimental) and Placebo (placebo comparator).

Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo.

Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release.

The registry classes the interventions as drug.

More on the Plan

The similarities in baseline values between the study groups will be compared using appropriate parametric tests.

Transformations of the data on order to meet statistical assumptions may be considered.

Data will be presented as mean±standard error.

The primary endpoint of the study is the change from baseline in albuminuria level at weeks 12, 26, 39 and 56 following Exenatide extended release and placebo treatments.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Type 2 Diabetes for at least 1 year. Ages 18-65 years (inclusive of ages 18 and 65). On ARBs/ACEi for at \>3months.

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: use of glp-1 receptor agonists or sglt-2 inhibitors therapy in the last 3 months; history or risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia); coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

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

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-01-10 with completion listed for 2019-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Urinary Albuminuria Levels (time frame: baseline and 52 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 15 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.