Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-27 @ 9:28 AM
Study NCT ID:
NCT00928057
Status:
COMPLETED
Last Update Posted:
2010-10-20
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
Sponsor:
Becton, Dickinson and Company
Organization:
Study Overview
Official Title:
Comparison of Glycemic Control Among Diabetics Using the 4mm x 32G BD Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).
The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
Detailed Description:
Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period.
Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.
Explanation of Visits and Timing of Assessments:
Visit 1:
* Screening
* Informed Consent
* Demographics
* Inclusion /Exclusion
* Hemoglobin A1c measurement (HbA1c)
Visit 2 (Baseline:)
* Insulin dose group assignment (Low dose or Regular dose)
* Randomization
* Fructosamine blood sample collected
* Dispense pen needle (PN) assigned first
Visit 3 (approximately 3 weeks after starting first PN)
* Pain rated by subject relative to baseline PN
* Review Adverse Events (AEs) and reported events of injection site leakage
* Fructosamine blood sample collected
* Dispense second assigned PN
Visit 4 (approximately 3 weeks after starting second PN):
* Review AEs and reported events of injection site leakage
* Fructosamine blood sample collected
* Pain rated relative to previously used PN
* Study Completion
Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.
Explanation of Visits and Timing of Assessments:
Visit 1:
* Screening
* Informed Consent
* Demographics
* Inclusion /Exclusion
* Hemoglobin A1c measurement (HbA1c)
Visit 2 (Baseline:)
* Insulin dose group assignment (Low dose or Regular dose)
* Randomization
* Fructosamine blood sample collected
* Dispense pen needle (PN) assigned first
Visit 3 (approximately 3 weeks after starting first PN)
* Pain rated by subject relative to baseline PN
* Review Adverse Events (AEs) and reported events of injection site leakage
* Fructosamine blood sample collected
* Dispense second assigned PN
Visit 4 (approximately 3 weeks after starting second PN):
* Review AEs and reported events of injection site leakage
* Fructosamine blood sample collected
* Pain rated relative to previously used PN
* Study Completion
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: