title: Lobeglitazone and pioglitazone as add-ons to metformin for patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, parallel-group, active-controlled, phase III clinical trial with a 28-week extension.
abstract: We aimed to compare the efficacy and safety of lobeglitazone and pioglitazone as add-ons to metformin in patients with type 2 diabetes. Patients who were inadequately controlled by metformin were randomized and treated once daily with either lobeglitazone (0.5 mg, n = 128) or pioglitazone (15 mg, n = 125) for 24 weeks, with a 28-week extension trial of lobeglitazone treatment in patients who consented. The primary endpoint was the change in glycated haemoglobin (HbA1c) concentration from baseline to week 24. At week 24, the mean change from baseline in HbA1c was -0.74% for the lobeglitazone group and -0.74% for the pioglitazone group, with a mean difference of 0.01% [95% confidence interval (CI) of difference, -0.16 to 0.18]. The effects of lobeglitazone on lipid variables and the adverse events associated with lobeglitazone were similar to those observed with pioglitazone. Lobeglitazone was not inferior to pioglitazone as an add-on to metformin in terms of their efficacy and safety.
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: S-M
authors.initials: SM
authors.lastname: Jin
authors.affiliation: Department of Endocrinology and Metabolism, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: C-Y
authors.initials: CY
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Y M
authors.initials: YM
authors.lastname: Cho
authors.affiliation: Department of Internal Medicine, School of Medicine, Chungnam National University, Daejeon, Republic of Korea.
authors.forename: B J
authors.initials: BJ
authors.lastname: Ku
authors.affiliation: Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University of College of Medicine, Seoul, Republic of Korea.
authors.forename: C W
authors.initials: CW
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, Severance Hospital, Yonsei University of Collage of Medicine, Seoul, Republic of Korea.
authors.forename: B-S
authors.initials: BS
authors.lastname: Cha
authors.affiliation: Diabetes Centre, Department of Endocrinology and Metabolism, Eulji General Hospital, Eulji University School of Medicine, Seoul, Republic of Korea.
authors.forename: K W
authors.initials: KW
authors.lastname: Min
authors.affiliation: Department of Internal Medicine, EwhaWomans University School of Medicine, Seoul, Republic of Korea.
authors.forename: Y A
authors.initials: YA
authors.lastname: Sung
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, Korea University, Seoul, Republic of Korea.
authors.forename: S H
authors.initials: SH
authors.lastname: Baik
authors.affiliation: Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: K W
authors.initials: KW
authors.lastname: Lee
authors.affiliation: Department of Endocrinology and Metabolism, Immunology, Cell Biology Core Laboratory, Institutes of Medical Science, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: K-H
authors.initials: KH
authors.lastname: Yoon
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: M-K
authors.initials: MK
authors.lastname: Lee
authors.affiliation: Department of Endocrinology and Metabolism, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: S W
authors.initials: SW
authors.lastname: Park
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance / Q000502:physiology; D008055:Lipids / Q000097:blood; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D000077205:Pioglitazone; D011743:Pyrimidines / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D008687:Metformin; D000077205:Pioglitazone; D011743:Pyrimidines; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human; C546215:lobeglitazone
keywords: antidiabetic drug; clinical trial; phase III study; randomised trial; thiazolidinediones