drugset / Trial / NCT02276196

Effect of LIXIsenatide on the Renal System

NCT02276196

Phase 4 Completed 40 enrolled Amsterdam UMC, location VUmc
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-09
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin glulisine Protein / enzyme biologic Subcutaneous
Subject Lixisenatide Peptide 20 ug Subcutaneous