Key result
Linagliptin 5 mg for 24 weeks showed a trend toward attenuating renal function loss in high CKD-risk patients with type 2 diabetes stratified by the CKD273 urinary proteome classifier.
Why the study?
Chronic kidney disease is a serious complication of hyperglycemia with scarce treatment options, and it was investigated whether an effect of linagliptin on kidney function could be unmasked by urinary proteome profiling in albuminuric T2D individuals.
Does linagliptin 5 mg attenuate renal function loss in albuminuric type 2 diabetes patients when stratified by the urinary proteome classifier CKD273?
RCT
1:1
Does linagliptin 5 mg attenuate renal function loss in albuminuric type 2 diabetes patients when stratified by the urinary proteome classifier CKD273?
The urinary proteome classifier CKD273 may help identify albuminuric type 2 diabetes patients at high risk for CKD progression and unmask potential kidney-protective effects of linagliptin.
Does not support routine linagliptin use for renal preservation; leaves open efficacy in larger CKD273-targeted T2D trials.
PURPOSE: Chronic kidney disease (CKD) is a serious complication of hyperglycemia and treatment options to slow its progression are scarce. Dipeptidyl peptidase-4 (DPP-4) inhibitors are common glucose-lowering drugs in type 2 diabetes (T2D). Among these, linagliptin has been suggested to exert kidney protective effects. It is investigated whether an effect of linagliptin on kidney function could be unmasked by characterizing the urinary proteome profile (UPP) in albuminuric T2D individuals. EXPERIMENTAL DESIGN: Participants of the MARLINA-T2D trial (NCT01792518) are randomized 1:1 to receive either linagliptin 5 mg or placebo for 24 weeks. A previously developed proteome-based classifier, CKD273, is assessed. RESULTS: Results confirm a significant correlation between CKD273 and clinical kidney parameters as well as with eGFR decline. Patient stratification using CKD273 at baseline, show a trend toward attenuation of renal function loss in high CKD-risk patients treated with linagliptin. Moreover, characterized are linagliptin affected peptides of which the majority contained a DPP-4 target sequence. CONCLUSIONS AND CLINICAL RELEVANCE: CKD273 is a promising tool for identifying patients at high risk for CKD progression and may unmask a potential of linagliptin to slow progressive kidney function loss in high CKD-risk patients. UPP characterization reveals a significant impact of linagliptin on urinary peptides.
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Siwy et al. (2019) conducted an RCT in Type 2 diabetes with albuminuria. Linagliptin vs. Placebo was evaluated on Renal function loss / eGFR decline. Linagliptin 5 mg for 24 weeks showed a trend toward attenuating renal function loss in high CKD-risk patients with type 2 diabetes stratified by the CKD273 urinary proteome classifier.
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