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

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

Research output: Contribution to journalArticle

25 Citations (Scopus)

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- c 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 (20.44% vs 0.16%, mean difference 20.6%, 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.

Original languageEnglish
Article numbere92843
JournalPLoS One
Volume9
Issue number4
DOIs
Publication statusPublished - 2014 Apr 15

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Medical problems
noninsulin-dependent diabetes mellitus
Type 2 Diabetes Mellitus
placebos
Placebos
glycohemoglobin
Safety
endpoints
apolipoprotein B
lipids
lobeglitazone
Apolipoprotein C-III
low density lipoprotein cholesterol
high density lipoprotein cholesterol
insulin resistance
Lipids
agonists
free fatty acids
Peroxisome Proliferator-Activated Receptors
Glycosylated Hemoglobin A

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

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. / Kim, Sin Gon; Kim, Doo Man; Woo, Jeong Taek; Jang, Hak Chul; Chung, Choon Hee; Ko, Kyung Soo; Park, Jeong Hyun; Park, Yong Soo; Kim, Sang Jin; Choi, Dong Seop.

In: PLoS One, Vol. 9, No. 4, e92843, 15.04.2014.

Research output: Contribution to journalArticle

Kim, Sin Gon ; Kim, Doo Man ; Woo, Jeong Taek ; Jang, Hak Chul ; Chung, Choon Hee ; Ko, Kyung Soo ; Park, Jeong Hyun ; Park, Yong Soo ; Kim, Sang Jin ; Choi, Dong Seop. / 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. In: PLoS One. 2014 ; Vol. 9, No. 4.
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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- c 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 (20.44{\%} vs 0.16{\%}, mean difference 20.6{\%}, 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.",
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T2 - A multicenter, randomized, double-blind, parallel-group, placebo controlled trial

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AU - Kim, Doo Man

AU - Woo, Jeong Taek

AU - Jang, Hak Chul

AU - Chung, Choon Hee

AU - Ko, Kyung Soo

AU - Park, Jeong Hyun

AU - Park, Yong Soo

AU - Kim, Sang Jin

AU - Choi, Dong Seop

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