293
Participants
Start Date
October 31, 2010
Primary Completion Date
May 31, 2012
Study Completion Date
May 31, 2012
4 mm x 32G Pen Needle
During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up.
8mm x 31G Pen Needle
During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
12.7mm x 29G Pen Needle
During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. When using the 12.7mm PN, subjects are instructed to insert either at an angle of 45 degrees, or to pinch up and hold the pen device at a 90 degree angle (straight in).
Corporate Lane Internal Medicine and Research Center, Virginia Beach
Mountain Diabetes and Endocrine Center, Asheville
Atlanta Diabetes Associates, Atlanta
University Diabetes and Endocrine Consultants, Chattanooga
International Diabetes Center (IDC), Minneapolis
Springfield Diabetes and Endocrine Center, Springfield
Diabetes and Endocrine Associates, Omaha
Clinical Trials of Texas, Inc, San Antonio
AMCR Institute, Inc., Escondido
The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center, Hackensack
Lead Sponsor
Becton, Dickinson and Company
INDUSTRY