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Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247558
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : July 25, 2012
HealthCore, Inc.
Information provided by (Responsible Party):
Pamlab, Inc. ( Pamlab, L.L.C. )

Brief Summary:
This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

Condition or disease Intervention/treatment
Diabetic Peripheral Neuropathy (DPN) Other: Metanx® (a medical food) Other: Not treated with Metanx®

Detailed Description:

The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates used to select the propensity matched patients will include: age; gender; health plan type and region; DCI score; presence/absence of nephropathy; ischemic heart disease; cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont pre-index period.

Claims information about patients selected for the study will be followed longitudinally to the end of data availability. This data stream will be used to determine treatment patterns for Metanx®, healthcare resource utilization, and cost.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
Study Start Date : November 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Mecobalamin

Group/Cohort Intervention/treatment
Test Cohort
100 randomized subjects administered Metanx®
Other: Metanx® (a medical food)
Patient cohort compliant on Metanx® BID therapy for >120 days

Control Cohort
400 subjects with diabetes mellitus meeting the same inclusion and exclusion criteria as the test cohort who have not been treated with Metanx®.
Other: Not treated with Metanx®
Non-treated comparative cohort

Primary Outcome Measures :
  1. All-Cause Health Plan Costs [ Time Frame: 12 months post-index period ]
    Total healthcare utilization and costs for patients treated with Metanx® will be compared to total healthcare utilization and costs for control patients who did not receive Metanx®. Cost data will be presented as Mean (SD) and median.

Secondary Outcome Measures :
  1. Disease-Attributable Resoure Use and Cost [ Time Frame: 12 month post-index period ]
    Disease attributable resource use and costs will be defined as medical claims associated with ICD-9 codes for disease(s) of interest. Total attributable resource use (units) and cost (allowed or paid), if available, will include: pharmacy (medication related to disease of interest); laboratory tests (all claims); office-based encounters and costs; emergency room visits and cost; other outpatient facility (e.g. clinic, home health); in-patient hospitalization; and durable medical equipment.

  2. Demographics of Patients Taking Metanx® [ Time Frame: >120 continuous days Metanx® therapy ]
    Statistical data including age (at index date); gender; comorbidities; prior and concomitant medications; and Metanx® utilization (e.g. dispensing quantity, number of fills, compliance, and persistency) will be collected to provide a descriptive analysis of the typical Metanx® patient characteristics.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with Diabetes and Peripheral Neuropathy or Peripheral Circulatory Disorder with Lower Limb Ulceration Who Have Been Treated with Metanx® or Not Treated with Metanx®.

Patients selected for the study will be identified from a review of available medical and pharmacy data during the period from 01/01/2003 to 06/30/2006. The date of the first pharmacy claim of interest within the intake period will be defined as the index date.


Inclusion Criteria:

  • Patients must have pharmacy claims for >120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date.
  • Patients must have a diagnosis of diabetes prior to or including the index date.
  • Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder.
  • Patients must have a diagnosis of lower limb ulcer.

Exclusion Criteria:

  • Patients will be excluded if they have <18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility.
  • Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with >1mg folic acid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01247558

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United States, Delaware
HealthCore, Inc.
Wilmington, Delaware, United States, 19801
Sponsors and Collaborators
Pamlab, L.L.C.
HealthCore, Inc.
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Study Director: Ron Wade, RPh, MS HealthCore, Inc.
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Responsible Party: Pamlab, L.L.C. Identifier: NCT01247558    
Other Study ID Numbers: M-006
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012
Keywords provided by Pamlab, Inc. ( Pamlab, L.L.C. ):
peripheral neurological disorder
peripheral circulation disorder
folic acid
vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs