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)

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.

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.