Diabetes Mellitus Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo-and Active-Controlled, Multi-center Study to Determine the Efficacy and Safety of TAK-379 in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.
Type 2 diabetes is a metabolic disease that has reached epidemic proportions. The global
incidence of this disease is estimated to increase from 120 million individuals to over 200
million by the year 2010. In type 2 diabetes, multiple metabolic defects contribute to
hyperglycemia. These include insulin resistance, inadequate insulin secretion, and excessive
hepatic glucose production. Nine classes of antihyperglycemic agents are currently approved
for the treatment of type 2 diabetes (insulin, sulfonylureas, biguanides, alpha-glycosidase
inhibitors, thiazolidinediones, glinides, glucagon-like peptide analogues, amylin analogues,
and dipeptidyl peptidase 4 inhibitors). Each class acts by a unique mechanism on 1 or more
of the metabolic defects.
Takeda Pharmaceutical Company Limited is developing TAK-379, a non-thiazolidinedione partial
proliferator-activated receptor agonist for the treatment of type 2 diabetes mellitus. Study
participation is anticipated to be approximately 4.5 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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