Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Collaborator:
HealthCore, Inc.
Information provided by (Responsible Party):
Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier:
NCT01247558
First received: November 17, 2010
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention
Diabetic Peripheral Neuropathy (DPN)
Other: Metanx® (a medical food)
Other: Not treated with Metanx®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • All-Cause Health Plan Costs [ Time Frame: 12 months post-index period ] [ Designated as safety issue: No ]
    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:
  • Disease-Attributable Resoure Use and Cost [ Time Frame: 12 month post-index period ] [ Designated as safety issue: No ]
    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.

  • Demographics of Patients Taking Metanx® [ Time Frame: >120 continuous days Metanx® therapy ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247558

Locations
United States, Delaware
HealthCore, Inc.
Wilmington, Delaware, United States, 19801
Sponsors and Collaborators
Pamlab, L.L.C.
HealthCore, Inc.
Investigators
Study Director: Ron Wade, RPh, MS HealthCore, Inc.
  More Information

No publications provided

Responsible Party: Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier: NCT01247558     History of Changes
Other Study ID Numbers: M-006
Study First Received: November 17, 2010
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
Metanx®
diabetes
neuropathy
peripheral neurological disorder
peripheral circulation disorder
folic acid
folate
L-methylfolate
vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
methylcobalamin

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014