Type 2 Diabetes Clinical Trial
Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist
that decreases insulin resistance in the periphery and liver resulting in increased
insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It
demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison
to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the
only drug which is considered as an effective therapeutic agent for improving non-alcoholic
fatty liver disease (NALFD) in type 2 diabetes (T2D).
The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4
study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on
intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.
Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet
once daily) for 24 weeks.
Primary endpoint is changes from baseline in controlled attenuation parameters (CAP)
measured by transient elastography (fibroscan) after treatment with Lobeglitazone.
Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated
albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function
parameters (AST, ALT, r-GT), and adverse events during the trial.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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