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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00763022 |
The purpose of this study was to determine the safety and efficacy of TAK-559 in Type 2 Diabetes subjects.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: TAK-559 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 302 |
Study Start Date: | November 2003 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TAK-559
TAK-559 16 mg, tablets, orally, once daily for up to 26 weeks.
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2: Experimental |
Drug: TAK-559
TAK-559 32 mg, tablets, orally, once daily for up to 26 weeks.
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3: Placebo Comparator |
Drug: Placebo
TAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.
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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.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Was required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 01-02-TL-559-014 |
Study First Received: | September 26, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00763022 |
Health Authority: | United States: Food and Drug Administration |
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes |
Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias |