Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus: A 16-week, randomized, double-blind, placebo-controlled phase III trial

M. K. Kim, E. J. Rhee, K. A. Han, A. C. Woo, M. K. Lee, B. J. Ku, C. H. Chung, K. A. Kim, H. W. Lee, I. B. Park, J. Y. Park, H. C. Chul Jang, K. S. Park, W. I. Jang, B. Y. Cha

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Abstract

The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0%, on stable metformin≥1000mg/day] were randomized 2:1 to receive 20mg teneligliptin plus metformin (n=136) or placebo plus metformin (n=68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were -0.78 % and -1.24 mmol/l (22.42mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.

Original languageEnglish
Pages (from-to)309-312
Number of pages4
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number3
DOIs
Publication statusPublished - 2015 Mar 1

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

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Kim, M. K. ; Rhee, E. J. ; Han, K. A. ; Woo, A. C. ; Lee, M. K. ; Ku, B. J. ; Chung, C. H. ; Kim, K. A. ; Lee, H. W. ; Park, I. B. ; Park, J. Y. ; Chul Jang, H. C. ; Park, K. S. ; Jang, W. I. ; Cha, B. Y. / Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus : A 16-week, randomized, double-blind, placebo-controlled phase III trial. In: Diabetes, Obesity and Metabolism. 2015 ; Vol. 17, No. 3. pp. 309-312.
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abstract = "The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0{\%}, on stable metformin≥1000mg/day] were randomized 2:1 to receive 20mg teneligliptin plus metformin (n=136) or placebo plus metformin (n=68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9{\%} in the teneligliptin group and 7.8{\%} in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were -0.78 {\%} and -1.24 mmol/l (22.42mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.",
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Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus : A 16-week, randomized, double-blind, placebo-controlled phase III trial. / Kim, M. K.; Rhee, E. J.; Han, K. A.; Woo, A. C.; Lee, M. K.; Ku, B. J.; Chung, C. H.; Kim, K. A.; Lee, H. W.; Park, I. B.; Park, J. Y.; Chul Jang, H. C.; Park, K. S.; Jang, W. I.; Cha, B. Y.

In: Diabetes, Obesity and Metabolism, Vol. 17, No. 3, 01.03.2015, p. 309-312.

Research output: Contribution to journalArticle

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T2 - A 16-week, randomized, double-blind, placebo-controlled phase III trial

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AU - Rhee, E. J.

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AU - Ku, B. J.

AU - Chung, C. H.

AU - Kim, K. A.

AU - Lee, H. W.

AU - Park, I. B.

AU - Park, J. Y.

AU - Chul Jang, H. C.

AU - Park, K. S.

AU - Jang, W. I.

AU - Cha, B. Y.

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N2 - The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0%, on stable metformin≥1000mg/day] were randomized 2:1 to receive 20mg teneligliptin plus metformin (n=136) or placebo plus metformin (n=68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were -0.78 % and -1.24 mmol/l (22.42mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.

AB - The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0%, on stable metformin≥1000mg/day] were randomized 2:1 to receive 20mg teneligliptin plus metformin (n=136) or placebo plus metformin (n=68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were -0.78 % and -1.24 mmol/l (22.42mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.

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