Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
Completed · Phase 4 · Has a placebo group
Conditions studied: Type 2 Diabetic Peripheral Neuropathy (DPN)
In brief
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.
Key facts
- Study ID
- NCT00726713
- Run by
- Pamlab, Inc.
- People needed
- 214
- Starts
- 2008-06-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-08-30
Who can join
Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Alabama at Birmingham School of Medicine — Birmingham, Alabama, United States
- Tulane University Health Sciences Center — New Orleans, Louisiana, United States
- Omaha VA Medical Center — Omaha, Nebraska, United States
- Dallas Diabetes and Endocrine Center — Dallas, Texas, United States
- dgd Research, Inc. — San Antonio, Texas, United States
- Scott and White Hospital & Clinic — Temple, Texas, United States
Full record on ClinicalTrials.gov
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