Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN) (NCT00726713) | Clinical Trial Compass
CompletedPhase 4
Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
United States214 participantsStarted 2008-06
Plain-language 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.
Who can participate
Age range
25 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks
Timeframe: VPT was measured a 0 (baseline), and 24 weeks
. 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;