GLPwatch

Effect of LIXIsenatide on the Renal System

NCT02276196 · Completed

Last updated 2026-05-28

This clinical trial tests the effects of the medication lixisenatide on kidney function in adults with diabetes-related kidney disease over an 8-week period.

Status Completed The study has finished.
Phase Phase 4 Monitors a drug already on the market.
Type Interventional (clinical trial)
Design Randomized, open-label (no blinding) treatment study
Participants 40 people
Who can join Ages 35–75 · all sexes
Timeline Started 2014-09 · est. completion 2016-04
Where 1 site · Netherlands

What this study is testing ClinicalTrials.gov NCT02276196 ↗

Description as written by the study sponsor.

Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, may hold promise in preventing the onset and progression of diabetic kidney disease. 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. Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.

Treatments tested

Main thing measuredChanges from baseline following 8-week treatment with a glucagon-like peptide(GLP)-1 receptor agonist versus insulin glulisine on renal hemodynamics, measured as glomerular filtration rate (GFR) / effective renal plasma flow (ERPF)
SponsorAmsterdam UMC, location VUmc
Conditions studiedDiabetic Kidney Disease, Diabetic Nephropathy, Diabetes Mellitus, Glucagon-Like Peptide 1
GLP-1 drugs lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02276196 ↗