Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles

NACompletedINTERVENTIONAL
Enrollment

293

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Interventions
DEVICE

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.

DEVICE

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.

DEVICE

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).

Trial Locations (10)

23462

Corporate Lane Internal Medicine and Research Center, Virginia Beach

28803

Mountain Diabetes and Endocrine Center, Asheville

30309

Atlanta Diabetes Associates, Atlanta

37403

University Diabetes and Endocrine Consultants, Chattanooga

55416

International Diabetes Center (IDC), Minneapolis

62704

Springfield Diabetes and Endocrine Center, Springfield

68131

Diabetes and Endocrine Associates, Omaha

78229

Clinical Trials of Texas, Inc, San Antonio

92026

AMCR Institute, Inc., Escondido

07601

The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center, Hackensack

Sponsors
All Listed Sponsors
lead

Becton, Dickinson and Company

INDUSTRY