The Nutritional Benefits of Metanx in Patients With Diabetic Peripheral Neuropathy (MEDIAN)

NCT01990092 | Unknown

• 1 other identifier: M-003
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 25

Brief Summary

The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks of treatment, and long-term effects will be evaluated over the duration of a 48 week treatment period.

Conditions

Diabetic Peripheral Neuropathy; B Vitamin Deficiency

Keywords

Metanx; B vitamins; neuropathy; nutrition

Outcome Measures

Primary Outcomes (1)

• Change in plasma methylmalonic acid (MMA) levels

  16 weeks

Secondary Outcomes (8)

• Change in plasma 5-methyltetrahydrofolate levels

  16 weeks

• Change in plasma vitamin B6 levels

  16 weeks

• Change in plasma vitamin B12 levels

  16 weeks

• Change in urine microalbumin/creatinine ratio

  48 weeks

• Change in epidermal nerve fiber density

  48 weeks

Study Arms (2)

Metanx

EXPERIMENTAL

Subjects will take 2 Metanx tablets once daily for 48 weeks.

Other: Metanx

Placebo

PLACEBO COMPARATOR

Subjects will take 2 placebo tablets once daily for 48 weeks.

Other: Placebo

Interventions

Metanx OTHER

Metanx is a prescription medical food.

Metanx

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be male or female between 25 and 80 years of age, inclusive, at the time of consent
• Have a diagnosis of diabetes mellitus Type 2 as defined by the American Diabetes Association and on stable therapy as defined per the investigator's opinion for at least 1 month before the Screening Visit.
• Have a diagnosis of DPN established at least 6 months but not greater than 7 years prior to Screening
• Alpha-2-delta ligand \[e.g., pregabalin (Lyrica) or gabapentin (Neurontin)
• Anticonvulsant \[e.g., carbamazepine, topiramate (Topamax), valproic acid (Depakote) or lamotrigine (Lamictal)\]
• Serotonin-norepinephrine Reuptake Inhibitor (SNRI) \[e.g., duloxetine (Cymbalta) or venlafaxine (Effexor)\]
• Tricyclic antidepressant (TCA) \[e.g., amitriptyline, nortriptyline, imipramine, and desipramine (Norpramin, Pertofrane)\]
• Have a score between 3 and 6, inclusive, on the Michigan Neuropathy Screening Instrument (MNSI) Part b
• Have a minimum score of 6 on the NTSS-6 at Screening
• Have negative urinalysis for drugs of abuse, such as amphetamines, barbiturates, cannabinoids, cocaine, or opiates
• Have a negative urine pregnancy test at Screening if female and of childbearing potential
• If female, must be either of nonchildbearing potential (surgically sterile or 2 years postmenopausal) or agree to use two methods of effective contraception such as hormonal contraception, intrauterine device or other mechanical contraception device, or condom plus spermicide during the subject's participation
• If male, must be surgically sterile or agree to use two methods of effective contraception such as condom plus spermicide during the subject's participation
• Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments
• Have provided written authorization for use and disclosure of protected health information

You may not qualify if:

• Be pregnant or lactating
• Have a history of amputation, skin ulceration, and/or active Charcot of either foot
• Have a history of previous surgery involving the spine or lower extremity, with residual symptoms of pain or difficulty with movement
• 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.)
• Have a history of surgery or hospitalization within 2 months prior to Screening or planned hospitalization at any time during the study
• Be taking systemic corticosteroids within 2 months prior to Screening, opiates or tramadol hydrochloride within 6 weeks prior to Screening, and/or immunosuppressives, or receiving radiotherapy within 6 months prior to Screening
• Be taking more than one anticonvulsant, serotonin-norepinephrine reuptake inhibitor (SNRI), or tricyclic antidepressant (TCA)
• Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot, history of claudication, or history of lower extremity vascular bypass surgery or angioplasty
• Have circulating glycated hemoglobin (HbA1c) exceeding 11% at Screening
• Have an estimated glomerular filtration rate (eGFR) less than or equal to 40 ml/min using the Modification of Diet in Renal Disease (MDRD) formula at Screening or have end-stage renal disorder requiring hemodialysis
• Have uncontrolled hypertension defined as sustained systolic blood pressure (SBP) greater than 200 mmHg or diastolic blood pressure (DBP) greater than 110 mmHg at screening
• Have lung disease (uncontrolled asthma or shortness of breath) within 2 months prior to Screening
• Use of any of the following supplements within 6 weeks before Screening: evening primrose oil, vitamin B12 injection, greater than 10 mg of vitamin B6, or greater than 800 µg of folate
• Have previously failed two or more prior therapies for painful DPN
• Currently abusing alcohol or drugs or have a history of such abuse within the past 3 years. (Alcohol abuse is defined as more than 2 drink units per day for women and more than 3 drink units per day for men. One drink unit is defined as 1.5 oz \[45 mL\] of distilled spirits, 5 oz \[150 mL\] of wine, or 12 oz \[360 mL\] of beer.)

Sponsors & Collaborators

• Pamlab, Inc.: lead

Study Sites (25)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Suncoast Clinical Research

Palm Harbor, Florida, 34684, United States

Location

Florida Medical Clinic

Wesley Chapel, Florida, 33544, United States

Location

North Chattahoochee Family Physicians, LLC

Johns Creek, Georgia, 30097, United States

Location

Willis-Knighton Physician Network / WKB Family Medicine Associates

Bossier City, Louisiana, 71111, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Urgent Care Specialists, LLC dba Hometown Urgent Care & Occupational Health

Dayton, Ohio, 45424, United States

Location

CRI Lifetree

Philadelphia, Pennsylvania, 19139, United States

Location

Trinity Clinical Research, LLC

Tullahoma, Tennessee, 37388, United States

Location

FutureSearch Trials of Neurology, L.P.

Austin, Texas, 78731, United States

Location

Centex Studies Inc.

Houston, Texas, 77062, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77098, United States

Location

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Location

Northeast Clinical Research of San Anotnio, LLC

Schertz, Texas, 78154, United States

Location

ClinPoint Trials, LLC

Waxahachie, Texas, 75165, United States

Location

Strelitz Diabetes Center

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Vitamin B Deficiency

Interventions

metanx

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Roy Freeman, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: March 1, 2018
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (25)