NCT00726713

Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

A 24 Week, Double-blind, Placebo-controlled, Multisite Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Pamlab, Inc. · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be randomly assigned to receive either Metanx or placebo for 6 months.

Conditions

• Type 2 Diabetic Peripheral Neuropathy (DPN)

Interventions

Type	Name	Description
OTHER	Metanx (a medical food)	Metanx one tablet twice a day
OTHER	Metanx placebo	Metanx placebo one tablet twice a day

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-05-01
• Completion: 2011-06-01
• First posted: 2008-08-01
• Last updated: 2013-08-30
• Results posted: 2013-08-30

Locations

6 sites across 1 country: United States