Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

NCT01247558 | Completed

• 1 other identifier: M-006
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• All-Cause Health Plan Costs

  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.

  12 months post-index period

Secondary Outcomes (2)

• Disease-Attributable Resoure Use and Cost

  12 month post-index period

• Demographics of Patients Taking Metanx®

  >120 continuous days Metanx® therapy

Study Arms (2)

Test Cohort

100 randomized subjects administered Metanx®

Other: Metanx® (a medical food)

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®

Interventions

Metanx® (a medical food) OTHER

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

Test Cohort

Not treated with Metanx® OTHER

Non-treated comparative cohort

Control Cohort

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamlab, L.L.C.: lead
• HealthCore, Inc.: collaborator

Study Sites (1)

HealthCore, Inc.

Wilmington, Delaware, 19801, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

metanx

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ron Wade, RPh, MS

  HealthCore, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

US (1)