Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01247558|
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : July 25, 2012
|Condition or disease||Intervention/treatment|
|Diabetic Peripheral Neuropathy (DPN)||Other: Metanx® (a medical food) Other: Not treated with Metanx®|
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|
|Estimated Enrollment :||500 participants|
|Official Title:||Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy|
|Study Start Date :||November 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
100 randomized subjects administered Metanx®
Other: Metanx® (a medical food)
Patient cohort compliant on Metanx® BID therapy for >120 days
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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247558
|United States, Delaware|
|Wilmington, Delaware, United States, 19801|
|Study Director:||Ron Wade, RPh, MS||HealthCore, Inc.|