Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy (NCT00760955) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
United States338 participantsStarted 2006-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria
* Individuals with a history…
What they're measuring
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.