CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 214 enrolled
Drug / intervention
Metanx (a medical food) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00726713
NCT00726713Phase 4Completed
CompareCT.gov

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

Pamlab, Inc.·interventional·Posted Aug 1, 2008·Updated Aug 30, 2013

In Brief

A Phase 4 clinical trial evaluating Metanx (a medical food) and Metanx placebo for Type 2 Diabetic Peripheral Neuropathy (DPN). Completed, enrolled 214 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetic Peripheral Neuropathy (DPN)
CountriesUnited States
CollaboratorsTulane University Health Sciences Center, VA Nebraska Western Iowa Health Care System, Scott and White Hospital & Clinic, Dallas Diabetes and Endocrine Center, University of Alabama at Birmingham, dgd Research, Inc., Baylor Health Care System

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2008
Enrollment StartJun 1, 2008
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.9 years ago

Interventions

Metanx (a medical food)other

Metanx one tablet twice a day

Metanx placeboother

Metanx placebo one tablet twice a day