Clinical trial NCT00928057: Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Pen Needle
Diabetes
Insulin
Glycemic
Pain
Fructosamine
Leakage
Hypoglycemia
Hyperglycemia
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Eligibility criteria: Inclusion Criteria:

* Insulin requiring diabetics (type 1 or type 2)
* Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
* 18 to 75 years of age, inclusive.
* Body Mass Index from 18 to 50 kg/m², inclusive.
* Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
* Largest single dose of insulin a day less than or equal to 40 units

Exclusion Criteria:

* Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).
* Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
* History of intravenous drug abuse (self-reported).
* Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
* Self-reported blood borne infection.
* Pregnant (from medical history only).

Primary outcomes:
measure: Percent (%) Absolute Change in Fructosamine
timeFrame: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
Secondary outcomes:
measure: Percent Absolute Change in Fructosamine, by Dose Group
timeFrame: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
measure: Number of Subjects With Severe Unexplained Hypoglycemic Events
timeFrame: During 3 weeks using each pen needle
measure: Number of Subjects With Severe Unexplained Hyperglycemic Events
timeFrame: During 3 weeks using each pen needle
measure: Relative Injection Pain Score Assessed by Subject
timeFrame: Visit 4: 18-24 days after starting 2nd pen needle
Other outcomes:
measure: Percentage of Subjects With at Least One Leakage Event
timeFrame: each PN was used for 3 weeks
measure: Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size
timeFrame: each PN was used for 3 weeks
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Escondido
country: United States
facility: AMCR Institute, Inc.
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
Study officials:
affiliation: Becton, Dickinson and Company
name: Kenneth Kassler-Taub, MD
role: STUDY_DIRECTOR
References:
citation: Hirsch LJ, Gibney MA, Albanese J, Qu S, Kassler-Taub K, Klaff LJ, Bailey TS. Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes. Curr Med Res Opin. 2010 Jun;26(6):1531-41. doi: 10.1185/03007995.2010.482499.
citation: Hirsch LJ, Gibney MA, Li L, Berube J. Glycemic control, reported pain and leakage with a 4 mm x 32 G pen needle in obese and non-obese adults with diabetes: a post hoc analysis. Curr Med Res Opin. 2012 Aug;28(8):1305-11. doi: 10.1185/03007995.2012.709181. Epub 2012 Jul 18.