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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.
Diabetes Obes Metab. 2013 Sep; 15(9):810-8.DO

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.

Authors+Show Affiliations

Department of Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23464664

Citation

Kadowaki, T, and K Kondo. "Efficacy, Safety and Dose-response Relationship of Teneligliptin, a Dipeptidyl Peptidase-4 Inhibitor, in Japanese Patients With Type 2 Diabetes Mellitus." Diabetes, Obesity & Metabolism, vol. 15, no. 9, 2013, pp. 810-8.
Kadowaki T, Kondo K. Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013;15(9):810-8.
Kadowaki, T., & Kondo, K. (2013). Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Diabetes, Obesity & Metabolism, 15(9), 810-8. https://doi.org/10.1111/dom.12092
Kadowaki T, Kondo K. Efficacy, Safety and Dose-response Relationship of Teneligliptin, a Dipeptidyl Peptidase-4 Inhibitor, in Japanese Patients With Type 2 Diabetes Mellitus. Diabetes Obes Metab. 2013;15(9):810-8. PubMed PMID: 23464664.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. AU - Kadowaki,T, AU - Kondo,K, Y1 - 2013/04/07/ PY - 2012/08/31/received PY - 2012/10/01/revised PY - 2013/03/03/accepted PY - 2013/3/8/entrez PY - 2013/3/8/pubmed PY - 2014/3/13/medline KW - DPP-4 inhibitor KW - HbA1c KW - teneligliptin KW - type 2 diabetes mellitus SP - 810 EP - 8 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 15 IS - 9 N2 - 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. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/23464664/Efficacy_safety_and_dose_response_relationship_of_teneligliptin_a_dipeptidyl_peptidase_4_inhibitor_in_Japanese_patients_with_type_2_diabetes_mellitus_ L2 - https://doi.org/10.1111/dom.12092 DB - PRIME DP - Unbound Medicine ER -