Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN) - Full Text View

Sponsor:	Pamlab, L.L.C.
Collaborators:	Tulane University Health Sciences Center Omaha VA Medical Center Scott and White Hospital & Clinic Dallas Diabetes and Endocrine Center University of Alabama at Birmingham dgd Research, Inc. Baylor University
Information provided by:	Pamlab, L.L.C.
ClinicalTrials.gov Identifier:	NCT00726713

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetic Peripheral Neuropathy (DPN)	Other: Metanx (a medical food) Other: Metanx placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 24 Week, Double-blind, Placebo-controlled, Multisite Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: B Vitamins Peripheral Nerve Disorders

Drug Information available for: Mecobalamin

U.S. FDA Resources

Further study details as provided by Pamlab, L.L.C.:

Primary Outcome Measures:

To determine if Metanx® (compared to placebo) improves sensory neuropathy in persons with Type 2 diabetes as measured by vibration perception threshold [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if Metanx® (compared to placebo) improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
To determine if Metanx® (compared to placebo) improves clinical examination as determined by the Neuropathy Disability Score (NDS) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
To determine if Metanx® (compared to placebo) affects a subject's plasma markers levels by: a. Raising Folate, B6, & B12; b. Lowering methyl malonic acid (MMA); and, c. Lowering homocysteine (Hcy) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
To determine if Metanx® (compared to placebo) affects a subject's "quality of life" as determined by the SF-36 questionnaire [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
To determine if Metanx® (compared to placebo) affects a subject's lower extremity pain level using a 10-point Visual Analog Scale at Baseline, 8, 16, and 24-week evaluation visits [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels by lowering hs-CRP, F2 Isoprostane, IL-6, TNF-α,and Urine Microalbumin and/or Urine Free Iron; and raising Potential Antioxidant (PAO) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
(Exploratory) Depression Evaluation: We will evaluate depression using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, 8, 16, and 24-week evaluation visits [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	216
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Metanx	Other: Metanx (a medical food) Metanx one tablet twice a day
Placebo Comparator: 2 Placebo	Other: Metanx placebo Metanx placebo one tablet twice a day

Eligibility

Ages Eligible for Study:	25 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female between 25 and 80 years of age (inclusive);
Documented diabetes mellitus Type 2 (Based upon ADA criteria);
Peripheral polyneuropathy: Vibration Perception Threshold (VPT) 25-45 Volts at hallux on either leg.
Adequate lower extremity vascular status:
- Palpable pedal pulse in both feet;
- No intermittent claudication;
- No history of lower extremity vascular bypass surgery or angioplasty
The subject is able to understand the information in the informed consent form and is willing and able to sign the consent.

Exclusion Criteria:

Amputation of any kind or an ulceration within the last two (2) years including at Screen;
History or active Charcot neuroarthropathy on either foot;
Previous surgery to spine or lower extremity with residual symptoms of pain or difficulty with movement;
Severe rheumatoid arthritis or osteoarthritis that would cause discomfort during causal walking or stair climbing;
Current treatment with systemic steroids, immunosuppressives, or radiotherapy;
Peripheral vascular disease defined as any nonpalpable foot pulse, history of claudication, or a history of lower extremity vascular bypass surgery or angioplasty;
Glycated hemoglobin (HbA1c) >9 at Screen.
Uncontrolled heart (Hypertension: BP > 160/90), or lung disease (uncontrolled asthma or shortness of breath) in the last 2 months prior to Screen;
End stage kidney disorder requiring hemodialysis or serum creatinine > 2.5X (normal upper limit);
The following supplements within 2 months prior to Screen: alpha lipoic acid; B12 injection; >10mg of B6; or, > 800mcg of folate;
Taking either an opiate at any dose or on the maximum dose of any anticonvulsant;
Pregnant or nursing;
Life expectancy < 12 months;
Initiated therapies for Painful Diabetic Neuropathy (pregabalin, gabapentin, duloxetine etc.) in the last 2 months prior to Screen;
Initiated new hyperglycemic, insulin, statin or hypertensive therapies within 2 months prior to Screen (dose modifications of current therapies are allowed at the discretion of the investigator);
Current alcohol or drug abuse (or history of such abuse within the past 3 years); and,
Not willing or able to follow procedures specified by the protocol and/or the instructions of the study personnel.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726713

Locations

United States, Alabama
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35294
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Nebraska
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105
United States, Texas
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
dgd Research, Inc.
San Antonio, Texas, United States, 78229
Scott and White Hospital & Clinic
Temple, Texas, United States, 76504

Sponsors and Collaborators

Pamlab, L.L.C.

Tulane University Health Sciences Center

Omaha VA Medical Center

Scott and White Hospital & Clinic

Dallas Diabetes and Endocrine Center

University of Alabama at Birmingham

dgd Research, Inc.

Baylor University

Investigators

Principal Investigator:

Vivian Fonseca, MD

Tulane University Health Sciences Center

More Information

No publications provided

Responsible Party:	Harold Koch, Jr., Senior Vice President Business Development & Chief Scientific Officer, Pamlab, LLC
ClinicalTrials.gov Identifier:	NCT00726713 History of Changes
Other Study ID Numbers:	M-001
Study First Received:	July 30, 2008
Last Updated:	December 3, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Pamlab, L.L.C.:

Metanx
diabetes
neuropathy
folic acid
folate

L-methylfolate
vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
methylcobalamin

Additional relevant MeSH terms:

Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Neuromuscular Diseases

Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012