Diabetic Peripheral Neuropathy (DPN)NCT01247558
Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy (DPN), run by Pamlab, L.L.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Metanx® (a medical food) and Not treated with Metanx®
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- Metanx® (a medical food), Not treated with Metanx®
- Keywords
- Metanx®, diabetes, neuropathy, peripheral neurological disorder, peripheral circulation disorder, folic acid, folate, L-methylfolate, vitamin B6, Pyridoxal 5'-phosphate, vitamin B12, methylcobalamin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metanx® (a medical food)Other
Patient cohort compliant on Metanx® BID therapy for >120 days
Not treated with Metanx®Other
Non-treated comparative cohort
| Study group | Role | What they receive |
|---|---|---|
| Test Cohort | 100 randomized subjects administered Metanx® Receives: 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®. Receives: Other: Not treated with Metanx® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-index period
Secondary outcomes (2)
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.
Measured: 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.
Measured: >120 continuous days Metanx® therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamlab, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Responsible party
- Sponsor
- Investigators
- Ron Wade, RPh, MS, Study director, HealthCore, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247558
- Sponsor's protocol ID
- M-006
- Status last verified
- Jul 2012
- First submitted
- 17 Nov 2010
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01247558
- Acronym / sponsor ID
- M-006
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Metanx®, diabetes, neuropathy, peripheral neurological disorder, peripheral circulation disorder, folic acid, folate, L-methylfolate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Pamlab, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Cohort | – | Other: Metanx® (a medical food)100 randomized subjects administered Metanx® |
| Control Cohort | – | Other: Not treated with Metanx®400 subjects with diabetes mellitus meeting the same inclusion and exclusion criteria as the test cohort who have not been treated with Metanx®. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metanx® (a medical food)Patient cohort compliant on Metanx® BID therapy for >120 days | Other | Test Cohort |
| Not treated with Metanx®Non-treated comparative cohort | Other | Control Cohort |
Primary outcome
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.
2 secondary outcomes
Disease-Attributable Resoure Use and Cost
Time frame: 12 month post-index period
Demographics of Patients Taking Metanx®
Time frame: >120 continuous days Metanx® therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Wade, RPh, MS study director
HealthCore, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy (DPN), run by Pamlab, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Health Plan Costs (time frame: 12 months post-index period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012.