Effects of Long-Term Lobeglitazone Treatment on Renal Function and Albuminuria in Korean Patients with Type 2 Diabetes Mellitus: A Multicenter Retrospective Observational Study (LUCKY)

Introduction: This study aimed to evaluate the long-term effects of lobeglitazone on renal function, glycemic control, metabolic parameters, and safety in Korean patients with type 2 diabetes mellitus (T2DM) treated for over 1 year. Methods: This retrospective, non-interventional, multicenter observational study was conducted at 30 institutions in South Korea. Patients with T2DM who had received lobeglitazone for at least 1 year and had available estimated glomerular filtration rate (eGFR) data were included. Primary outcomes were changes in eGFR and urinary albumin–creatinine ratio (UACR). Secondary outcomes included changes in HbA1c, body weight, lipid profiles, insulin resistance, β-cell function, and adverse events (AEs). Results: Of the 2743 enrolled patients, 2648 and 2500 were analyzed for safety and efficacy, respectively. Of 2648 patients analyzed for safety, 1655 (62.5%) were male and 993 (37.5%) were female. Baseline eGFR (82.0 ± 22.0 ml/min/1.73 m²) remained stable over 6 years across all chronic kidney disease (CKD) stages. UACR was unchanged in 77–83% of patients throughout follow-up. HbA1c significantly decreased from baseline (− 0.99% at year 1 to − 0.93% at year 6; all p < 0.0001), indicating sustained glycemic control. Lipid profiles and HOMA-IR improved, while HOMA- β remained stable. Overall, 1165 AEs occurred in 531 patients (20.05%), mostly consistent with the established safety profile; events of special interest were rare (< 1%). Conclusions: Long-term lobeglitazone treatment was not associated with deterioration of renal function or worsening of albuminuria status across all CKD stages, while demonstrating sustained glycemic efficacy and a favorable safety profile in real-world clinical practice. These findings support lobeglitazone as a clinically relevant long-term treatment option for patients with T2DM, including those with pre-existing CKD.