Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
Condition: Type 2 Diabetic Peripheral Neuropathy (DPN)
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Metanx (a medical food); Metanx placebo
Intervention description: Metanx one tablet twice a day; Metanx placebo one tablet twice a day
Intervention MeSH terms: Vitamin B 12
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 214.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Metanx; diabetes; neuropathy; folic acid; folate; L-methylfolate; vitamin B6; Pyridoxal 5'-phosphate; vitamin B12; methylcobalamin

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between 25 and 80 years of age (inclusive);

          2. Documented diabetes mellitus Type 2 (Based upon ADA criteria);

          3. Peripheral polyneuropathy: Vibration Perception Threshold (VPT) 25-45 Volts at hallux
             on either leg.

          4. Adequate lower extremity vascular status:

               -  Palpable pedal pulse in both feet;

               -  No intermittent claudication;

               -  No history of lower extremity vascular bypass surgery or angioplasty

          5. The subject is able to understand the information in the informed consent form and is
             willing and able to sign the consent.

        Exclusion Criteria:

          1. Amputation of any kind or an ulceration within the last two (2) years including at
             Screen;

          2. History or active Charcot neuroarthropathy on either foot;

          3. Previous surgery to spine or lower extremity with residual symptoms of pain or
             difficulty with movement;

          4. Severe rheumatoid arthritis or osteoarthritis that would cause discomfort during
             causal walking or stair climbing;

          5. Current treatment with systemic steroids, immunosuppressives, or radiotherapy;

          6. Peripheral vascular disease defined as any nonpalpable foot pulse, history of
             claudication, or a history of lower extremity vascular bypass surgery or angioplasty;

          7. Glycated hemoglobin (HbA1c) >9 at Screen.

          8. Uncontrolled heart (Hypertension: BP > 160/90), or lung disease (uncontrolled asthma
             or shortness of breath) in the last 2 months prior to Screen;

          9. End stage kidney disorder requiring hemodialysis or serum creatinine > 2.5X (normal
             upper limit);

         10. The following supplements within 2 months prior to Screen: alpha lipoic acid; B12
             injection; >10mg of B6; or, > 800mcg of folate;

         11. Taking either an opiate at any dose or on the maximum dose of any anticonvulsant;

         12. Pregnant or nursing;

         13. Life expectancy < 12 months;

         14. Initiated therapies for Painful Diabetic Neuropathy (pregabalin, gabapentin,
             duloxetine etc.) in the last 2 months prior to Screen;

         15. 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);

         16. Current alcohol or drug abuse (or history of such abuse within the past 3 years); and,

         17. Not willing or able to follow procedures specified by the protocol and/or the
             instructions of the study personnel.