Clinical trial NCT01247558: Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
Official title: Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy (DPN)
Keywords: Metanx®
diabetes
neuropathy
peripheral neurological disorder
peripheral circulation disorder
folic acid
folate
L-methylfolate
vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
methylcobalamin
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: HealthCore, Inc.
First posted: 2010-11-24
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: All-Cause Health Plan Costs
timeFrame: 12 months post-index period
Secondary outcomes:
measure: Disease-Attributable Resoure Use and Cost
timeFrame: 12 month post-index period
measure: Demographics of Patients Taking Metanx®
timeFrame: >120 continuous days Metanx® therapy
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: HealthCore, Inc.
state: Delaware
Study officials:
affiliation: HealthCore, Inc.
name: Ron Wade, RPh, MS
role: STUDY_DIRECTOR
References: