NDLI: Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus.

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Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus.

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Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Kadowaki, T. Kondo, K.
Spatial Coverage	Japan
Description	Country affiliation: Japan Author Affiliation: Kadowaki T ( Department of Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.)
Abstract	AIM: To assess the efficacy, safety and dose-response relationship of once-daily teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group study, patients (n = 324) were randomized to receive teneligliptin 10, 20 or 40 mg, or placebo, once daily before breakfast for 12 weeks. The primary endpoint was the change in haemoglobin (Hb)A1c from baseline to week 12. RESULTS: All teneligliptin-treated groups showed significantly greater reductions in HbA1c and fasting plasma glucose (FPG) than did the placebo group. The differences between the teneligliptin 10, 20 or 40 mg groups and the placebo group for the change in HbA1c were -0.9 [least-squares (LS) mean; 95% confidence interval: -1.0, -0.7], -0.9 (-1.1, -0.7) and -1.0 (-1.2, -0.9)%, respectively (all, p < 0.001). The respective LS means for FPG were -17.8 (-23.4, -12.1), -16.9 (-22.6, -11.2) and -20.0 (-25.7, -14.3) mg/dl (all, p < 0.001). There were no significant differences in HbA1c among the three doses of teneligliptin. The incidence of adverse events and adverse drug reactions was similar in each group. The incidence of hypoglycaemia was not significantly different among the four groups. CONCLUSIONS: Treatment with teneligliptin for 12 weeks provided significant and clinically meaningful reductions in HbA1c and FPG across the dose range studied and was generally well tolerated in Japanese patients with T2DM.
File Format	HTM / HTML
ISSN	14628902
Issue Number	9
Volume Number	15
e-ISSN	14631326
Journal	Diabetes, Obesity and Metabolism
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2013-09-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Metabolism Discipline Endocrinology Discipline Pharmacology Discipline Diabetology Diabetes Mellitus, Type 2 Drug Therapy Dipeptidyl-peptidase Iv Inhibitors Therapeutic Use Pyrazoles Thiazolidines Adult Aged Area Under Curve Asian Continental Ancestry Group Statistics & Numerical Data Blood Glucose Metabolism Blood Epidemiology Administration & Dosage Adverse Effects Dose-response Relationship, Drug Double-blind Method Drug Administration Schedule Fasting Female Hemoglobin A, Glycosylated Humans Japan Male Middle Aged Time Factors Treatment Outcome Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Endocrinology, Diabetes and Metabolism Internal Medicine Endocrinology

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