Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathies

In brief

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.

Key facts

Study ID

NCT00760955

Run by

Takeda

People needed

338

Starts

2006-09-01

Expected to finish

2008-02-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Is willing to follow an American Diabetes Association or similar recommended dietary regimen.

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.
• 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.

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Huntington Beach, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — Tustin, California, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Sunrise, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Englewood, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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