Status:
COMPLETED
Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
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 currentl...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00928057
Start Date
June 1 2009
End Date
November 1 2009
Last Update
October 20 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Radiant Research
Birmingham, Alabama, United States, 35209
2
AMCR Institute, Inc.
Escondido, California, United States, 92026
3
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
4
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057