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Completed

NCT Number: NCT01247558

Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy (DPN) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthCore, Inc.

Wilmington, Delaware, 19801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metanx® (a medical food)

Other

Patient cohort compliant on Metanx® BID therapy for >120 days

Not treated with Metanx®

Other

Non-treated comparative cohort

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pamlab, L.L.C.

Industry

Collaborators

  • HealthCore, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2010
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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