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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.
Diabetes Obes Metab. 2016 May; 18(5):528-32.DO

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 (20 mg) 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 24 weeks. 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 -1.21 mmol/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 24 weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.

Authors+Show Affiliations

Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Korea.Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.Division of Endocrinology, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine, Uijeognbu St. Mary's Hospital, Catholic University Medical College, Uijeongbu, Korea.Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Korea.Department of Internal Medicine, CHA Bungdang Medical Center, CHA University College of Medicine, Seongnam, Korea.Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26749529

Citation

Hong, S, et al. "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." Diabetes, Obesity & Metabolism, vol. 18, no. 5, 2016, pp. 528-32.
Hong S, Park CY, Han KA, et al. 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. Diabetes Obes Metab. 2016;18(5):528-32.
Hong, S., Park, C. Y., Han, K. A., Chung, C. H., 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. (2016). 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. Diabetes, Obesity & Metabolism, 18(5), 528-32. https://doi.org/10.1111/dom.12631
Hong S, et al. 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. Diabetes Obes Metab. 2016;18(5):528-32. PubMed PMID: 26749529.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hong,S, AU - Park,C-Y, AU - Han,K A, AU - Chung,C H, 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, Y1 - 2016/03/18/ PY - 2015/08/23/received PY - 2015/12/23/revised PY - 2015/12/29/accepted PY - 2016/1/11/entrez PY - 2016/1/11/pubmed PY - 2017/1/7/medline KW - DPP-IV inhibitor KW - antidiabetic drug KW - phase III study KW - type 2 diabetes SP - 528 EP - 32 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 18 IS - 5 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 (20 mg) 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 24 weeks. 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 -1.21 mmol/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 24 weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/26749529/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_ L2 - https://doi.org/10.1111/dom.12631 DB - PRIME DP - Unbound Medicine ER -