Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus

Phase 4 Completed 219 enrolled Takeda

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.

Timeline

Start: 2017-02-18
Primary completion: 2017-10-21
Completion: 2017-10-21

Outcome

Missed primary endpoint

paper The between-group difference in the change from baseline to week 12 in DTR-QOL total score was 2.418 (95% confidence interval - 1.546, 6.382; P = 0.2305). PMID 31214997 ↗

Publications

Ishii H, Suzaki Y, Miyata Y, Matsui S. Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor. Diabetes Ther. 2019 Aug;10(4):1369-1380. doi: 10.1007/s13300-019-0643-1. Epub 2019 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Alogliptin	Unknown	—	Oral
Comparator	Anagliptin	Small molecule	—	Oral
Comparator	Linagliptin	Unknown	—	Oral
Comparator	SAXAGLIPTIN ANHYDROUS	Small molecule	—	Oral
Comparator	Sitagliptin	Small molecule	—	Oral
Comparator	Teneligliptin	Small molecule	—	Oral
Subject	Trelagliptin	Small molecule	50 mg	Oral
Subject	Trelagliptin	Small molecule	100 mg	Oral
Comparator	Vildagliptin	Other / unclassified	—	Oral