C-C motif-ligand 2 inhibition with emapticap pegol (NOX-E36) in type 2 diabetic patients with albuminuria
Why the study?
Does emapticap pegol reduce albuminuria and improve glycemic control in type 2 diabetic patients with albuminuria?
Population
75 type 2 diabetic patients with albuminuria
Comparison
Emapticap pegol 0.5 mg/kg administered… vs Placebo administered subcutaneously twice weekly…
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
24 weeks
Authors
Discussion
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Member takes
Implication
Emapticap fails to significantly reduce ACR versus placebo; leaves open its potential benefits on albuminuria and HbA1c for confirmation in larger trials.
Structured PICO
Does emapticap pegol reduce albuminuria and improve glycemic control in type 2 diabetic patients with albuminuria?
P
Population
75 type 2 diabetic patients with albuminuria
I
Intervention
Emapticap pegol (NOX-E36) 0.5 mg/kg administered subcutaneously twice weekly for 12 weeks
C
Comparator
Placebo administered subcutaneously twice weekly for 12 weeks
O
Outcome
Safety, tolerability, urinary albumin/creatinine ratio (ACR), and HbA1c at 12 weekssurrogate
Emapticap pegol was safe and well-tolerated, showing potential disease-modifying effects on albuminuria and HbA1c that require confirmation in larger trials.
Limitations
- Exploratory study
- Post hoc analysis required to show significant ACR difference between arms
Cite This Study
Menne et al. (2016) studied this question.