Type 2 Diabetes Clinical Trial
Official title:
A Phase 4, Monocenter, Randomized, Double-blind, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Linagliptin Versus the Sulfonylurea (SU) Derivative Glimepiride on Renal Physiology and Biomarkers in Metformin-treated Patients With Type 2 Diabetes Mellitus (T2DM)
The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4 inhibitor linagliptin on the renal system in 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 (DPP-4i), 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 DPP-4i
on fasting and postprandial renal physiology and biomarkers in patients with type 2
diabetes.
Forty-eight patients with type 2 diabetes will undergo an eight week intervention with
linagliptin or glimepiride in order to assess changes in the outcome parameters.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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