1. 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
- Author
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Hyun Shik Son, Chul Woo Ahn, Sangmo Hong, Moon-Kyu Lee, Min Kyong Moon, Yong‐Wook Cho, Choon Hee Chung, Sung Woo Park, Cheol-Young Park, Kyung Ah Han, Chang Beom Lee, Hak Chul Jang, and Bon Jeong Ku
- Subjects
Blood Glucose ,Time Factors ,endocrine system diseases ,Endocrinology, Diabetes and Metabolism ,Administration, Oral ,Type 2 diabetes ,Dipeptidyl peptidase-4 inhibitor ,030204 cardiovascular system & hematology ,Gastroenterology ,DPP‐IV inhibitor ,0302 clinical medicine ,Endocrinology ,Diet, Diabetic ,Clinical endpoint ,Medicine ,Incidence ,Combined Modality Therapy ,Thiazolidines ,type 2 diabetes ,medicine.drug ,medicine.medical_specialty ,030209 endocrinology & metabolism ,Hypoglycemia ,Placebo ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,Republic of Korea ,Research Letter ,Internal Medicine ,Humans ,Teneligliptin ,Adverse effect ,Exercise ,Glycated Hemoglobin ,antidiabetic drug ,Dipeptidyl-Peptidase IV Inhibitors ,business.industry ,Type 2 Diabetes Mellitus ,medicine.disease ,Research Letters ,phase III study ,Surgery ,Diabetes Mellitus, Type 2 ,Hyperglycemia ,Patient Compliance ,Pyrazoles ,Insulin Resistance ,business - 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
- Published
- 2016