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

Status:	Archived
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	October 2010
End Date:	April 2012

Comparison of Glycemic Control in Obese Subjects With Diabetes Using the BD Ultra-Fineâ„¢ Nano 4mm x 32G Pen Needle, and Either the BD Ultra-Fineâ„¢ Short 8mm x 31G Pen Needle or the BD Ultra Fineâ„¢ 12.7mm x 29G Pen Needle

Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin
therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy
profile of longer pen needles may appeal to many diabetic patients as the shorter needle may
be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in
length are generally used for insulin injection in patients considered thin or normal
weight, longer (12.7 mm) needles are still often prescribed for overweight or obese patients
with diabetes. Since skin thickness is nearly constant across a range of body mass index
(BMI), a clear rationale exists for the use of shorter needles in obese patients. (Gibney et
al., CMRO 2010)

The primary purpose of this study is to evaluate whether the BD Ultra-Fineâ„¢ Nano 4mm x 32
Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent
glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fineâ„¢ 8mm x 31G and
the BD Ultra-Fineâ„¢ 12.7mm x 29G pen needles in obese subjects with diabetes.

Each subject's participation is expected to last a total of 7 months and includes a
screening visit, a three-week wash-in period (one week with each of the three different size
pen needles) followed by two consecutive 12 week study periods. The purpose of the three
week wash-in period is to minimize the number of dropouts during the following study periods
by ensuring that subjects have experience using each of the three study needles and find
them generally acceptable for use during the study.

Only subjects who complete the wash-in period and confirm their agreement to continue
participating will be randomized into one of the two study arms. Subjects will be randomly
assigned to use the BD Ultra-Fineâ„¢ 4mm pen needle and either the BD Ultra-Fineâ„¢ 8mm pen
needle or the BD Ultra-Fineâ„¢ 12.7mm pen needle. The randomization will also specify which
of the two study pen needles to be used first. Half of the study subjects will use the BD
Ultra-Fineâ„¢ 4mm and BD Ultra-Fineâ„¢ 8mm pen needles (4mm/8mm arm) and the other half will use
the BD Ultra-Fineâ„¢ 4mm and the BD Ultra-Fineâ„¢ 12.7mm pen needles (4mm/12.7mm arm). At the
end of the first 12 week study period subjects will switch to the other assigned pen needle
for the second and final study period.

Glycemic control (based on HbA1c concentrations) will be assessed at baseline and at the end
of each 12 week study period.

We found this trial at

sites

AMCR Institute, Inc.

700 West El Norte Parkway
Oceanside-Escondido, California 92026

877-567-2627