Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
1 other identifier
interventional
173
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
October 20, 2010
CompletedOctober 20, 2010
September 1, 2010
5 months
June 24, 2009
August 12, 2010
September 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent (%) Absolute Change in Fructosamine
Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula: Percent absolute change in FRU, or %\|∆ FRU\|= 100\*\[FRU(4mm)-FRU(5 or 8mm)\]/\[FRU(5 or 8mm)\].
3 weeks per pen needle, from visit 2-3 and visit 3-4.
Secondary Outcomes (4)
Percent Absolute Change in Fructosamine, by Dose Group
3 weeks per pen needle, from visit 2-3 and visit 3-4.
Number of Subjects With Severe Unexplained Hypoglycemic Events
During 3 weeks using each pen needle
Number of Subjects With Severe Unexplained Hyperglycemic Events
During 3 weeks using each pen needle
Relative Injection Pain Score Assessed by Subject
Visit 4: 18-24 days after starting 2nd pen needle
Other Outcomes (2)
Percentage of Subjects With at Least One Leakage Event
each PN was used for 3 weeks
Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size
each PN was used for 3 weeks
Study Arms (2)
4 mm / 8 mm PN
EXPERIMENTALSubjects randomized to this study arm used either the 4mm PN or the 8mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined.
4 mm / 5 mm PN
EXPERIMENTALSubjects randomized to this study arm used either the 4mm PN or the 5mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined.
Interventions
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up.
Eligibility Criteria
You may qualify if:
- 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).
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Radiant Research
Birmingham, Alabama, 35209, United States
AMCR Institute, Inc.
Escondido, California, 92026, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
Related Publications (2)
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.
PMID: 20429832RESULTHirsch 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.
PMID: 22762347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kenneth Kassler-Taub, MD
- Organization
- BD Medical, Medical Affairs
Study Officials
- STUDY DIRECTOR
Kenneth Kassler-Taub, MD
Becton, Dickinson and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 24, 2009
First Posted
June 25, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
October 20, 2010
Results First Posted
October 20, 2010
Record last verified: 2010-09