PMID- 33099742 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210319 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 12 IP - 1 DP - 2021 Jan TI - Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus. PG - 171-181 LID - 10.1007/s13300-020-00948-1 [doi] AB - INTRODUCTION: The aim of this analysis was to evaluate the efficacy of lobeglitazone on albuminuria at 24 weeks of follow-up in patients with type 2 diabetes mellitus (T2DM) compared with pioglitazone using data from a randomized, double-blinded phase III trial. METHODS: In the phase III trial, patients who were inadequately controlled with metformin received 0.5 mg of lobeglitazone or 15 mg of pioglitazone for 24 weeks. Post hoc, exploratory analysis was used to investigate mean changes from baseline in the urine albumin-creatinine ratio (UACR) between the lobeglitazone (N = 104) and pioglitazone (N = 101) treatment groups. RESULTS: After 24 weeks of treatment, UACR was slightly decreased in the lobeglitazone group (- 4.3 mg/g creatinine [Cr]) compared to baseline and slightly increased in the pioglitazone group (5.2 mg/g Cr), with no change in the estimated glomerular filtration rate in either group; this difference was not statistically significant (P = 0.476). The incidence of new-onset microalbuminuria (2.4%) and the progression of albuminuria by > 1 stage (2.9%) in the lobeglitazone group were lower than the respective values in the pioglitazone group (6.8 and 6.1%, respectively). Of the patients in the lobeglitazone group, 50% exhibited regression to normoalbuminuria, compared to 39.3% of the patients in the pioglitazone. In subjects in the lobeglitazone group with micro- and macroalbuminuria, UACR tended to be more decreased and HbA1c was more reduced compared to those with normoalbuminuria (P = 0.014). CONCLUSION: Lobeglitazone had a tendency to improve albuminuria in patients with T2DM and had comparable effects on albuminuria as pioglitazone which has demonstrated beneficial effects. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01106131. FAU - Kim, Kyung-Soo AU - Kim KS AUID- ORCID: 0000-0002-7738-2284 AD - Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea. FAU - Hong, Sangmo AU - Hong S AUID- ORCID: 0000-0002-8535-0565 AD - Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Republic of Korea. FAU - Ahn, Hong-Yup AU - Ahn HY AD - Department of Statistics, Dongguk University-Seoul, Seoul, Republic of Korea. FAU - Park, Cheol-Young AU - Park CY AUID- ORCID: 0000-0002-9415-9965 AD - Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. cydoctor@chol.com. LA - eng SI - ClinicalTrials.gov/NCT01106131 PT - Journal Article DEP - 20201024 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 PMC - PMC7843821 OTO - NOTNLM OT - Albuminuria OT - Diabetes mellitus, type 2 OT - Pioglitazone OT - Thiazolidinediones EDAT- 2020/10/26 06:00 MHDA- 2020/10/26 06:01 PMCR- 2020/10/24 CRDT- 2020/10/25 20:16 PHST- 2020/09/11 00:00 [received] PHST- 2020/10/10 00:00 [accepted] PHST- 2020/10/26 06:00 [pubmed] PHST- 2020/10/26 06:01 [medline] PHST- 2020/10/25 20:16 [entrez] PHST- 2020/10/24 00:00 [pmc-release] AID - 10.1007/s13300-020-00948-1 [pii] AID - 948 [pii] AID - 10.1007/s13300-020-00948-1 [doi] PST - ppublish SO - Diabetes Ther. 2021 Jan;12(1):171-181. doi: 10.1007/s13300-020-00948-1. Epub 2020 Oct 24.