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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy (DPN)
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19801
      • HealthCore, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Attributable Resoure Use and Cost	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.	12 month post-index period
Demographics of Patients Taking Metanx®	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.	>120 continuous days Metanx® therapy

Collaborators and Investigators

• Sponsor: Pamlab, L.L.C.
• Collaborators: HealthCore, Inc.
• Investigators: Study Director: Ron Wade, RPh, MS, HealthCore, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 23, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: diabetes; vitamin B12; folate; neuropathy; vitamin B6; L-methylfolate; folic acid; Pyridoxal 5'-phosphate; methylcobalamin; Metanx®; peripheral neurological disorder; peripheral circulation disorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Vitamin B 12
• Other Study ID Numbers: M-006