NCT00726713CompletedPhase 4
A 24 Week, Double-blind, Placebo-controlled, Multisite Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pamlab, Inc.
- Enrollment
- 214
- Locations
- 6
- Primary Endpoint
- Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Metanx
Intervention: Metanx (a medical food) (Other)
2
Placebo Comparator
Placebo
Intervention: Metanx placebo (Other)
Outcomes
Primary Outcomes
Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks
Time Frame: VPT was measured a 0 (baseline), and 24 weeks
Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.
Secondary Outcomes
- Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)(NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks)
- Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24(NDS scores were taken at 0 (Baseline), 16, and 24 weeks)
- Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24(Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks)
- Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24(SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks)
- Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24(VAS scores were taken at 0 (Baseline) and 24 weeks)
- (Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24(Analyte levels were taken at 0 (Baseline) and 24 weeks)
- (Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24(HADS Scores scores were taken at 0 (Baseline) and 24 weeks)
- Change From Baseline in Total Homocysteine at Week 16 and 24(Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks)
- (Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24(Analyte levels were taken at 0 (Baseline) and 24 weeks)
- (Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24(Analyte levels were taken at 0 (Baseline) and 24 weeks)
Investigators
Study Sites (6)
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