Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Study to Evaluate the Efficacy and Safety of 3 Doses of TAK-583 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
2 other identifiers
interventional
338
2 countries
38
Brief Summary
The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily (QD), in the treatment of neuropathy caused by diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedJune 22, 2016
June 1, 2016
1.4 years
September 24, 2008
June 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline for a composite measure of Maximal Nerve Conduction Velocity of the Peroneal and Median Motor Nerves and the Median and Sural Sensory Nerves.
Month 6 or Final Visit
Secondary Outcomes (10)
Change from Baseline in Electrophysiological Parameters for Individual Nerves.
Month 6 or Final Visit
Change from Baseline in Sensory Sub-Composite and Motor Sub-Composite Scores.
Months 3 and 6 or Final Visit
Change in Vibration Perception Threshold.
Months 3 and 6 or Final Visit
Change in Pain Scores.
Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in Neurological Examination Score.
Months 3 and 6 or Final Visit
- +5 more secondary outcomes
Study Arms (4)
TAK-583 5 mg QD
EXPERIMENTALTAK-583 50 mg QD
EXPERIMENTALTAK-583 100 mg QD
EXPERIMENTALPlacebo QD
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Female subjects must be post-menopausal or status post documented hysterectomy and bilateral oophorectomy.
- Has fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed not clinically significant by the investigator prior to randomization.
- Has Type 1 or type 2 diabetes, as defined by World Health Organization Criteria.
- Has mild to Moderate Diabetic Peripheral Neuropathy defined as:
- Confirmed abnormality of at least two nerve conduction velocity parameters as defined by the Neurological Core Laboratory.
- Sural sensory nerve potential amplitude greater than or equal to 1 μV (microvolt).
- Has glycosylated hemoglobin less than or equal to 10%.
- Is on stable pain medications for at least 3 weeks prior to randomization, if applicable.
- Has a glomerular filtration rate calculated by Modification of Diet in Renal Disease of greater than or equal to 45 mL/min/ body surface area.
- Spot albumin/creatinine ratio of less than 300 mg/g creatinine or 33.9 mg/mmol creatinine.
- Has acceptable clinical laboratory test results as defined by:
- Hemoglobin Greater than or equal to 9.0 g/dL or 5.58 mmol/L
- Thyroid stimulating hormone Within normal limits
- Free T4 index Within normal limits
- B12 level Within normal limits
- +1 more criteria
You may not qualify if:
- Individuals with a history of other neuropathies due to causes other than diabetes such as alcohol abuse, liver or renal disease, uremia, toxic exposure, genetic factors, autoimmune disorders, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders.
- Has clinical or electrophysiologic evidence of bilateral carpal tunnel syndrome.
- Has a significant skin abnormality or ulcerative changes in their lower extremities that may interfere with the performance of the study related procedures.
- Has a body mass index greater than 45 kg/m2.
- Participants with uncontrolled hypertension or a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure of greater than 95 mm Hg.
- Has a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, clinically significant abnormal electrocardiograms, New York Heart Association Functional Classification III or IV, or documented cerebrovascular accident.
- Has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval greater than 450 milliseconds).
- Has a history of additional risk factors for Torsades de pointes.
- Is 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:
- Medications that prolong the QT/QTc interval.
- Lipoic acid.
- Linolenic acid (primrose oil).
- Inositol.
- Topiramate.
- Acetyl-L-Carnitine.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (38)
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Peoria, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Palm Beach Gardens, Florida, United States
Unknown Facility
Sunrise, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Englewood, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Greenville, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
North Bay, Ontario, Canada
Unknown Facility
Laval, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 26, 2008
Study Start
September 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 22, 2016
Record last verified: 2016-06