Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus

A 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial

S. Hong, C. Y. Park, K. A. Han, Choon Hee Chung, B. J. Ku, H. C. Jang, C. W. Ahn, M. K. Lee, M. K. Moon, H. S. Son, C. B. Lee, Y. W. Cho, S. W. Park

Research output: Contribution to journalLetter

7 Citations (Scopus)

Abstract

We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n=142) were randomized 2:1 into two different treatment groups as follows: 99 received teneligliptin (20mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21mmol/l (-1.72, -0.70), respectively (all p<0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.

Original languageEnglish
Pages (from-to)528-532
Number of pages5
JournalDiabetes, Obesity and Metabolism
Volume18
Issue number5
DOIs
Publication statusPublished - 2016 May 1

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Dipeptidyl-Peptidase IV Inhibitors
Type 2 Diabetes Mellitus
Placebos
Safety
Glycosylated Hemoglobin A
Least-Squares Analysis
Hypoglycemia
Fasting
3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
Exercise
Diet
Glucose
Incidence

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Hong, S. ; Park, C. Y. ; Han, K. A. ; Chung, Choon Hee ; Ku, B. J. ; Jang, H. C. ; Ahn, C. W. ; Lee, M. K. ; Moon, M. K. ; Son, H. S. ; Lee, C. B. ; Cho, Y. W. ; Park, S. W. / Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus : A 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial. In: Diabetes, Obesity and Metabolism. 2016 ; Vol. 18, No. 5. pp. 528-532.
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abstract = "We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n=142) were randomized 2:1 into two different treatment groups as follows: 99 received teneligliptin (20mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94{\%} [least-squares (LS) mean -1.22, -0.65] and -1.21mmol/l (-1.72, -0.70), respectively (all p<0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.",
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Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus : A 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial. / Hong, S.; Park, C. Y.; Han, K. A.; Chung, Choon Hee; Ku, B. J.; Jang, H. C.; Ahn, C. W.; Lee, M. K.; Moon, M. K.; Son, H. S.; Lee, C. B.; Cho, Y. W.; Park, S. W.

In: Diabetes, Obesity and Metabolism, Vol. 18, No. 5, 01.05.2016, p. 528-532.

Research output: Contribution to journalLetter

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T1 - Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus

T2 - A 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial

AU - Hong, S.

AU - Park, C. Y.

AU - Han, K. A.

AU - Chung, Choon Hee

AU - Ku, B. J.

AU - Jang, H. C.

AU - Ahn, C. W.

AU - Lee, M. K.

AU - Moon, M. K.

AU - Son, H. S.

AU - Lee, C. B.

AU - Cho, Y. W.

AU - Park, S. W.

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N2 - We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n=142) were randomized 2:1 into two different treatment groups as follows: 99 received teneligliptin (20mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21mmol/l (-1.72, -0.70), respectively (all p<0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.

AB - We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n=142) were randomized 2:1 into two different treatment groups as follows: 99 received teneligliptin (20mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21mmol/l (-1.72, -0.70), respectively (all p<0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.

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