title: Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.
abstract: OBJECTIVE
  The aim of this study was to assess the glucose-lowering and lipid-modifying effects, and safety profile of lobeglitazone, a novel peroxisome proliferator-activated receptor- γ agonist, compared to placebo as a monotherapy in patients with type 2 diabetes.
  
  
  METHODS
  In this 24-week, multicenter, randomized, double-blind, parallel-group, placebo controlled study, 173 patients were randomly assigned (a 2∶1 ratio) to lobeglitazone 0.5 mg (n=115) or matching placebo (n=58) orally once daily. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to the end of treatment. The secondary endpoints included various glycemic parameters, lipid parameters and safety profile (ClinicalTrials.gov number NCT01001611).
  
  
  RESULTS
  At 24 weeks, a significant reduction in HbA1c was observed with lobeglitazone versus placebo (-0.44% vs 0.16%, mean difference -0.6%, p<0.0001). The goal of HbA1c <7% was achieved significantly more in the lobeglitazone group compared to the placebo group (44% vs 12%, p<0.0001). Markers of insulin resistance were also improved in the lobeglitazone group. In addition, lobeglitazone treatment significantly improved triglycerides, high density lipoprotein cholesterol, small dense low density lipoprotein cholesterol, free fatty acid, and apolipoprotein-B/CIII compared to placebo (p<0.01, respectively). More weight gain was observed in the lobeglitazone group than the placebo group (0.89 kg vs - 0.63 kg, mean difference 1.52 kg, p<0.0001). The safety profile was comparable between the two groups and lobeglitazone was well tolerated.
  
  
  CONCLUSIONS
  Lobeglitazone 0.5 mg showed a favorable balance in the efficacy and safety profile. The results support a potential role of lobeglitazone in treating type 2 diabetes.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01001611.
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
authors.forename: Sin Gon
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.
authors.forename: Doo Man
authors.initials: DM
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea.
authors.forename: Jeong-Taek
authors.initials: JT
authors.lastname: Woo
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea.
authors.forename: Choon Hee
authors.initials: CH
authors.lastname: Chung
authors.affiliation: Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea.
authors.forename: Kyung Soo
authors.initials: KS
authors.lastname: Ko
authors.affiliation: Department of Internal Medicine, Inje University Pusan Paik Hospital, Pusan, Korea.
authors.forename: Jeong Hyun
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.
authors.forename: Yong Soo
authors.initials: YS
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Soon Chun Hyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Sang Jin
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
authors.forename: Dong Seop
authors.initials: DS
authors.lastname: Choi
mesh_terms: D000368:Aged; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D011743:Pyrimidines; D045162:Thiazolidinediones; C546215:lobeglitazone
references.citation: Diabetes Care. 2004 Jan;27 Suppl 1:S68-71
references.pmid: 14693930
references.citation: Lancet. 2005 Oct 8;366(9493):1279-89
references.pmid: 16214598
references.citation: Clin Ther. 2011 Nov;33(11):1819-30
references.pmid: 22047812
references.citation: Biochim Biophys Acta. 2007 Aug;1771(8):1065-81
references.pmid: 17428730
references.citation: Diabetes Care. 2000 Nov;23(11):1605-11
references.pmid: 11092281
references.citation: Endocr J. 2006 Jun;53(3):325-30
references.pmid: 16710073
references.citation: Eur J Med Chem. 2005 Sep;40(9):862-74
references.pmid: 15908051
references.citation: Trends Endocrinol Metab. 2012 May;23(5):205-15
references.pmid: 22513163
references.citation: Nat Rev Drug Discov. 2010 Sep;9(9):668-9
references.pmid: 20811368
references.citation: Eur J Med Chem. 2004 May;39(5):433-47
references.pmid: 15110969
references.citation: Diabetologia. 2012 Jul;55(7):1953-62
references.pmid: 22460763
references.citation: Diabetes Care. 2007 Oct;30(10):2458-64
references.pmid: 17595355
references.citation: N Engl J Med. 2006 Dec 7;355(23):2427-43
references.pmid: 17145742
references.citation: Curr Med Res Opin. 2012 Jul;28(7):1213-20
references.pmid: 22697273
references.citation: Diab Vasc Dis Res. 2007 Sep;4(3):194-203
references.pmid: 17907109
references.citation: Arch Intern Med. 2010 Jul 26;170(14):1191-1201
references.pmid: 20656674
references.citation: N Engl J Med. 2004 Sep 9;351(11):1106-18
references.pmid: 15356308
references.citation: JAMA. 2005 Nov 23;294(20):2581-6
references.pmid: 16239637