Effect of LIXIsenatide on the Renal System

What Was Tested

The trial (phase 4) is built around Lixisenatide.

However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes.

Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1 receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes.

It had two arms (groups): Lixisenatide (experimental) and Insulin glulisine (active comparator).

Lixisenatide will be administered subcutaneously, once daily for 8 weeks.

Insulin glulisine will be administered subcutaneously, once daily for 8 weeks.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 35 years up to 75 years.

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

Examples of who could join: Females must be post-menopausal. Age: 35 - 75 years. Body Mass Index: \>25 kg/m2. Hypertension should be under control, i.e. \<140/90 mmHg, and treated with an angiotensin-converting enzyme inhibitor or angiotensin-II-receptor blocker for at least 3 months. Albuminuria should be treated with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin-II-receptor blocker (ARB) for at least 3 months.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: hypoglycemia unawareness based on investigator judgment; history of severe hypoglycemia that required emergency hospital treatment within 3 months prior to screening; current urinary tract infection and active nephritis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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

It started in 2014-09 with completion listed for 2016-04.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Renal damage, measured by urine biomarkers, Renal tubular function and Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Lixisenatide in 40 people.

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

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