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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

Author

Listed:
  • Sin Gon Kim
  • Doo Man Kim
  • Jeong-Taek Woo
  • Hak Chul Jang
  • Choon Hee Chung
  • Kyung Soo Ko
  • Jeong Hyun Park
  • Yong Soo Park
  • Sang Jin Kim
  • Dong Seop Choi

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. Research Design and 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

Suggested Citation

  • Sin Gon Kim & Doo Man Kim & Jeong-Taek Woo & Hak Chul Jang & Choon Hee Chung & Kyung Soo Ko & Jeong Hyun Park & Yong Soo Park & Sang Jin Kim & Dong Seop Choi, 2014. "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," PLOS ONE, Public Library of Science, vol. 9(4), pages 1-7, April.
    • Handle: RePEc:plo:pone00:0092843
    DOI: 10.1371/journal.pone.0092843
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