Phase 4
N=214
Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
Type 2 Diabetic Peripheral Neuropathy (DPN)
Bottom Line
View on ClinicalTrials.gov: NCT00726713 ↗Enrolled (actual)
214
Serious AEs
6.1%
Results posted
Aug 2013
Primary outcome: Primary: Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks — 32.16; 33.88; -1.96; -3.27 volts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metanx (a medical food) (Other); Metanx placebo (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Pamlab, Inc.
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks |
32.16; 33.88; -1.96; -3.27 | — |
| SECONDARY Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6) |
3.73; 3.45; -0.09; -0.40; -0.96; -0.53 | =0.013 sig |
| SECONDARY Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24 |
7.51; 7.47; -0.78; -0.18; -0.47; -0.36 | =0.027 sig |
| SECONDARY Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24 |
42.19; 43.04; 7.25; -1.07; 7.53; -2.75 | =0.0001 sig |
| SECONDARY Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24 |
40.74; 39.03; 0.03; 0.87; 50.96; 52.66 | =0.0306 sig |
| SECONDARY Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24 |
3.26; 3.25; -0.27; -0.03 | — |
| SECONDARY (Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24 |
3.66; 3.68; -0.25; 0.07; 1.69; 2.01 | — |
| SECONDARY (Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24 |
4.16; 4.42; -1.03; -0.45 | =0.054 |
| SECONDARY Change From Baseline in Total Homocysteine at Week 16 and 24 |
9.71; 9.47; -2.70; 0.58; -2.68; 0.48 | — |
| SECONDARY (Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24 |
6.46; 7.44; -0.71; 0.13 | — |
| SECONDARY (Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24 |
1094.52; 1102.15; 7.95; 5.29 | — |
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
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00726713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.