Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Study of the Safety and Efficacy of TAK-559 Compared to Placebo in the Treatment of Patients With Type 2 Diabetes Mellitus
The purpose of this study was to determine the safety and efficacy of TAK-559, once daily (QD), in Type 2 Diabetes subjects.
Insulin is a primary regulator of blood glucose concentrations. A subnormal response to
circulating insulin levels at target tissues leads to a decrease in insulin-mediated glucose
uptake. Insulin resistance is associated with normal to high insulin levels and is often
accompanied by dyslipidemia, a disruption in lipid metabolism resulting in increased
triglycerides and low-density lipoprotein levels as well as decreased high-density
lipoprotein levels in patients with type 2 diabetes mellitus. In the early stages of insulin
resistance, a compensatory mechanism of increased insulin secretion by the pancreas
maintains normal to near-normal glucose levels. Once the pancreas fails to maintain the
increased insulin output, overt type 2 diabetes mellitus occurs.
TAK-559 is a novel oxyiminoalkanoic acid under investigation for use as an oral agent in the
treatment of patients with type 2 diabetes mellitus. TAK-559 has partial peroxisome
proliferator-activated receptor-alpha agonist activity, potent peroxisome
proliferator-activated receptor-alpha activity, and modest peroxisome proliferator-activated
receptor-gamma activity at high concentrations in nonclinical models.
This study was designed to evaluate the safety and glycemic control of TAK-559 in patients
with type 2 diabetes mellitus whose symptoms were managed by diet and exercise.
;
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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