Despite the rapidly increasing prevalence of
non-alcoholic fatty liver disease (
NAFLD) in
type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel
thiazolidinedione (TZDs),
lobeglitazone (Duvie) in T2D patients with
NAFLD. We recruited
drug-naïve or
metformin-treated T2D patients with
NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan®; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents. Fifty patients with CAP values above 250 dB/m were treated once daily with 0.5 mg
lobeglitazone for 24 weeks. The primary endpoint was a decline in CAP values, and secondary endpoints included changes in components of glycemic,
lipid, and liver profiles.
Lobeglitazone-treated patients showed significantly decreased CAP values (313.4 dB/m at baseline vs. 297.8 dB/m at 24 weeks; P = 0.016), regardless of
glycemic control.
Lobeglitazone improved HbA(1C) values (7.41% [57.5 mM] vs. 6.56% [48.2 mM]; P < 0.001), as well as the
lipid and liver profiles of the treated patients. Moreover, multivariable linear regression analysis showed that hepatic fat reduction by
lobeglitazone was independently associated with baseline values of CAP, liver stiffness, and liver
enzymes, and
metformin use.
Lobeglitazone treatment reduced intrahepatic fat content, as assessed by transient liver elastography, and improved glycemic, liver, and
lipid profiles in T2D patients with
NAFLD. Further randomized controlled trials using liver histology as an end point are necessary to evaluate the efficacy of
lobeglitazone for
NAFLD treatment.