Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

This study has been completed.
Sponsor:
Collaborators:
Tulane University Health Sciences Center
Omaha VA Medical Center
Scott and White Hospital & Clinic
Dallas Diabetes and Endocrine Center
University of Alabama at Birmingham
dgd Research, Inc.
Baylor Health Care System
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT00726713
First received: July 30, 2008
Last updated: July 26, 2013
Last verified: July 2013
Results First Received: May 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetic Peripheral Neuropathy (DPN)
Interventions: Other: Metanx (a medical food)
Other: Metanx placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 373 patients screened, 214 entered the study , and 200 completed. The study was conducted at 6 participating U.S. sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Inclusion criteria included individuals 25 and 80 years of age, documented diabetes Type 2, Peripheral polyneuropathy, adequate lower extremity vascular status, and subject competence. 17 exclusion criteria including an HbA1c >9, uncontrolled heart or lung disease, and vitamin B supplementation, contributed to the number of screening failures.

Reporting Groups
  Description
Metanx Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
Placebo Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day

Participant Flow:   Overall Study
    Metanx     Placebo  
STARTED     106     108  
COMPLETED     99     101  
NOT COMPLETED     7     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metanx Metanx one tablet twice a day
Placebo Placebo one tablet twice a day
Total Total of all reporting groups

Baseline Measures
    Metanx     Placebo     Total  
Number of Participants  
[units: participants]
  106     108     214  
Age  
[units: years]
Mean ± Standard Deviation
  62.29  ± 8.54     62.95  ± 9.17     62.6  ± 8.9  
Gender  
[units: participants]
     
Female     33     33     66  
Male     73     75     148  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks   [ Time Frame: VPT was measured a 0 (baseline), and 24 weeks ]

2.  Secondary:   Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)   [ Time Frame: NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks ]

3.  Secondary:   Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24   [ Time Frame: NDS scores were taken at 0 (Baseline), 16, and 24 weeks ]

4.  Secondary:   Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24   [ Time Frame: Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks ]

5.  Secondary:   Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24   [ Time Frame: SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks ]

6.  Secondary:   Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24   [ Time Frame: VAS scores were taken at 0 (Baseline) and 24 weeks ]

7.  Secondary:   (Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24   [ Time Frame: Analyte levels were taken at 0 (Baseline) and 24 weeks ]

8.  Secondary:   (Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24   [ Time Frame: HADS Scores scores were taken at 0 (Baseline) and 24 weeks ]

9.  Secondary:   Change From Baseline in Total Homocysteine at Week 16 and 24   [ Time Frame: Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks ]

10.  Secondary:   (Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24   [ Time Frame: Analyte levels were taken at 0 (Baseline) and 24 weeks ]

11.  Secondary:   (Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24   [ Time Frame: Analyte levels were taken at 0 (Baseline) and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Adverse Event reporting detailed in the “Other Adverse Events” section was provided only with specificity to the affected Organ System. Additional detail for the “Other Adverse Events” was not available at the time of reporting.  


Results Point of Contact:  
Name/Title: Page Young, Clinical Project Manager
Organization: Pamlab Inc.
phone: 985-867-5788
e-mail: pyoung@pamlab.com


Publications of Results:

Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT00726713     History of Changes
Other Study ID Numbers: M-001
Study First Received: July 30, 2008
Results First Received: May 2, 2013
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board