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Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

NCT ID: NCT01247558

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Diabetic Peripheral Neuropathy (DPN)

Keywords

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Metanx® diabetes neuropathy peripheral neurological disorder peripheral circulation disorder folic acid folate L-methylfolate vitamin B6 Pyridoxal 5'-phosphate vitamin B12 methylcobalamin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Test Cohort

100 randomized subjects administered Metanx®

Metanx® (a medical food)

Intervention Type OTHER

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®.

Not treated with Metanx®

Intervention Type OTHER

Non-treated comparative cohort

Interventions

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Metanx® (a medical food)

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

Intervention Type OTHER

Not treated with Metanx®

Non-treated comparative cohort

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HealthCore, Inc.

INDUSTRY

Sponsor Role collaborator

Pamlab, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Wade, RPh, MS

Role: STUDY_DIRECTOR

HealthCore, Inc.

Locations

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HealthCore, Inc.

Wilmington, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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M-006

Identifier Type: -

Identifier Source: org_study_id