Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

What Was Tested

This registered not phased trial tested Dulaglutide.

The purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2 Diabetic Nephropathy.

It had two arms (groups): Dulaglutide (experimental) and other hypoglycemic agents not including GLP-1 receptor agonists (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, it is not clear whether the above-mentioned properties are involved in the EMT process of renal tubular epithelial cells.

A random number method was applied for grouping in this study.

Dulaglutide and other hypoglycemic agents were administered according to the drug package insert.

Of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.

Who Took Part

300 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: All adults aged 18 and above. No minors involved in the study.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: patients with other types of kidney disease; urinary tract infection; type 1 diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Dulaglutide study did not mask who received what.

It started in 2021-10-30 with completion listed for 2023-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Evaluation of the urinary albumin-to-creatinine ratio (time frame: 3,6 and 12 months after dulaglutide injection treatment). Evaluation of the biomarkers of the epithelial-mesenchymal transition process (time frame: 3,6 and 12 months after dulaglutide injection treatment).

It also tracked 3 secondary outcomes, for example Evaluation of the estimated glomerular filtration rate, Evaluation of the cystatin C and Evaluation of adverse event.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Dulaglutide in 300 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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