Diabetes Mellitus Clinical Trial
Official title:
A Phase 4, Mono-center, Randomized, Open Label, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist Lixisenatide Versus Insulin Glulisine on Renal Physiology and Biomarkers in Insulin Glargine-treated Patients With Type 2 Diabetes Mellitus
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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