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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
302
Change in Baseline in Glycosylated hemoglobin.
Time frame: Weeks: 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Glycosylated hemoglobin.
Time frame: Weeks: 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Fasting Plasma Glucose.
Time frame: Weeks: 2, 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Serum insulin.
Time frame: Weeks: 4, 12, 16, 20 and Final Visit.
Change in Baseline in C-peptide.
Time frame: Weeks: 4, 12, 16, 20 and Final Visit.
Change in Baseline in Lipids (triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, very-low-density lipoprotein).
Time frame: Weeks: 12, 16, 20 and Final Visit.
Change in Baseline in Lipids (low-density lipoprotein fractionation).
Time frame: Weeks: 12, 16, 20 and Final Visit.
Change in Baseline in Apolipoproteins Al and B100.
Time frame: Final Visit.
Change in Baseline in Free fatty acids.
Time frame: Weeks: 12, 16, 20 and Final Visit.
Markers of thrombosis (plasminogen activator inhibitor-i).
Time frame: Weeks: 4, 12, 16, 20 and Final Visit.
Markers of thrombosis (fibrinogen).
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Time frame: Weeks: 4, 12, 16, 20 and Final Visit.
Markers of inflammation (interleukin-6).
Time frame: Weeks: 4, 12, 16, 20 and Final Visit.
Markers of inflammation (C-reactive protein).
Time frame: Weeks: 4, 12, 16, 20 and Final Visit.
Urinary albumin/creatinine ratio.
Time frame: Weeks: 12, 16, 20 and Final Visit.