Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
NCT ID: NCT00760955
Last Updated: 2016-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
338 participants
INTERVENTIONAL
2006-09-30
2008-02-29
Brief Summary
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Detailed Description
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TAK-583 is a synthetic compound currently under development for the treatment of diabetic polyneuropathy. The purpose of this study is to evaluate the safety and efficacy of TAK-583 for the treatment of mild to moderate diabetic polyneuropathy in subjects with type 1 or type 2 diabetes mellitus. Study participation is anticipated to be about 8 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAK-583 5 mg QD
TAK-583
TAK-583 5 mg, tablets, orally, once daily for up to 6 months.
TAK-583 50 mg QD
TAK-583
TAK-583 50 mg, tablets, orally, once daily for up to 6 months.
TAK-583 100 mg QD
TAK-583
TAK-583 100 mg, tablets, orally, once daily for up to 6 months.
Placebo QD
Placebo
TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.
Interventions
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TAK-583
TAK-583 5 mg, tablets, orally, once daily for up to 6 months.
TAK-583
TAK-583 50 mg, tablets, orally, once daily for up to 6 months.
TAK-583
TAK-583 100 mg, tablets, orally, once daily for up to 6 months.
Placebo
TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* Is willing to follow an American Diabetes Association or similar recommended dietary regimen.
Exclusion Criteria
* 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.
* Nerve growth factors.
* Capsaicin.
* CYP3A4 inhibitors (amiodarone, diltiazem, Verapamil)
* HIV protease inhibitors
* Itraconazole
* Ketoconazole
* macrolide antibiotics
* CYP 3A4 inducers
* Has an alanine aminotransferase level of greater than 1.5 times upper limit of normal, active liver disease or jaundice or Total bilirubin greater than 1.2 times upper limit of normal.
* Has a 12-hour urinary cortisol test greater than 264 nmol/night (95.6 mcg/night) at screening.
* Has clinically significant (as determined by the investigator) or unstable: pulmonary, gastrointestinal, hepatic, hematologic, musculoskeletal, osteoporosis, osteopenia, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) diseases.
* Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
* Has any other serious disease or condition at screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subjects according to the protocol.
* Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
* Has a known hypersensitivity to a compound related to TAK-583.
* Is currently participating in another investigational study or has participated in an investigational study within the past 30 days.
18 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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VP Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Huntington Beach, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Tustin, California, United States
Largo, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Palm Beach Gardens, Florida, United States
Sunrise, Florida, United States
West Palm Beach, Florida, United States
Decatur, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Las Vegas, Nevada, United States
Englewood, New Jersey, United States
Buffalo, New York, United States
Staten Island, New York, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Vancouver, British Columbia, Canada
Kingston, Ontario, Canada
North Bay, Ontario, Canada
Laval, Quebec, Canada
Québec, Quebec, Canada
Countries
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Other Identifiers
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U1111-1129-7781
Identifier Type: REGISTRY
Identifier Source: secondary_id
01-06-TL-583-006
Identifier Type: -
Identifier Source: org_study_id
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