Summary:
A multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and nutritional benefits of Metanx® in subjects with diabetic peripheral neuropathy.
Qualified Participants Must:
• Be male or female
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Be between 25 and 80 years of age
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Have a diagnosis of diabetes mellitus Type 2
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Have a diagnosis of DPN established at least 6 months but not greater than 5 years prior to Screening and, if receiving DPN-related medication, doses must be stable for at least 6 weeks
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Have negative urinalysis for drugs of abuse, such as amphetamines, barbiturates, cannabinoids, cocaine, or opiates
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Other inclusion criteria apply
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NOT be pregnant or lactating
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NOT have a history of amputation, skin ulceration, and/or active Charcot of either foot
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Not have a history of previous surgery involving the spine or lower extremity, with residual symptoms of pain or difficulty with movement
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Not have Crohn's disease or a history of any type of bariatric surgery or any surgical resection of all or part of the stomach, duodenum, jejunum, and/or ileum. (Previous surgical resections of the colon that spared the stomach, duodenum, jejunum and ileum are allowed.)
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Not have a history of surgery or hospitalization within 2 months prior to Screening or planned hospitalization at any time during the study
NOT be taking systemic corticosteroids, opiates, tramadol hydrochloride, immunosuppressives, or receiving radiotherapy within 6 months prior to Screening
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Not be taking more than one anticonvulsant, serotonin-norepinephrine reuptake inhibitor (SNRI), or tricyclic antidepressant (TCA)
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more exclusion criteria apply
Qualified Participants May Receive:
$50 per completed visit for time/travel.