Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies.

Abstract

OBJECTIVE:

To assess the safety and efficacy of long-term administration of teneligliptin alone and in combination with oral antidiabetic drugs in Japanese type 2 diabetes mellitus (T2DM) patients with insufficient glycemic control.

METHODS:

This post-hoc pooled analysis used data from two Phase III clinical studies involving 702 Japanese patients. We evaluated teneligliptin as monotherapy and combined with a sulfonylurea, glinide, biguanide, or α-glucosidase inhibitor. Safety measures included adverse events (AEs), adverse reactions and hypoglycemia. The main efficacy measure was the change in glycated hemoglobin (HbA1c) from baseline.

RESULTS:

Incidences of AEs and adverse reactions were similar among the teneligliptin monotherapy group and all combination therapy groups except the combination with sulfonylurea. Hypoglycemia was more frequent in the sulfonylurea combination therapy group than in other groups. Teneligliptin administered once daily as monotherapy or combination therapy resulted in a decrease in HbA1c, which was maintained for 52 weeks. Bodyweight showed no change or a slight increase at the end of 52 weeks in all groups.

CONCLUSIONS:

This pooled analysis provides evidence for the safety and efficacy of long-term use of teneligliptin as monotherapy or combination therapy in Japanese T2DM patients.

• Authors: Takashi Kadowaki, Fuyuhiko Marubayashi, Shoko Yokota, Makoto Katoh, Hiroaki Iijima
• Journal: Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 16 Issue 7 Pg. 971-81 (May 2015) ISSN: 1744-7666 [Electronic] England
• PMID: 25861982 (Publication Type: Journal Article, Meta-Analysis)

Chemical References

• 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Pyrazoles
• Thiazolidines

Topics

• Asian People
• Blood Glucose (metabolism)
• Clinical Trials, Phase III as Topic
• Diabetes Mellitus, Type 2 (drug therapy)
• Drug Therapy, Combination
• Glycated Hemoglobin (metabolism)
• Humans
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Pyrazoles (adverse effects, therapeutic use)
• Thiazolidines (adverse effects, therapeutic use)