Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
|ClinicalTrials.gov Identifier: NCT01334606|
Recruitment Status : Terminated (This study was terminated due to unanticipated recruitment difficulties.)
First Posted : April 13, 2011
Results First Posted : September 2, 2013
Last Update Posted : September 19, 2013
The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or more single daily injections of greater than 40 units of insulin.
Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be enrolled so as to allow for pre-specified analysis of this subgroup.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Device: 4 mm x 32G pen needle (Nano) Device: 8mm x 31G pen needle (Short)|
This is an open-label, randomized two period crossover study. Each subject's participation is expected to last about seven weeks and includes a brief enrolment period followed by two consecutive three week treatment periods (Period 1 and Period 2).
In Period 1, subjects will use the first assigned study pen needle (either the 4mm Nano or the 8mm Short) to self-administer daily all their pen-based diabetes medications. Upon completion of Period 1, subjects will switch to the alternate pen needle for Period 2. The randomization schedule will determine the order of pen needle use.
Blood samples for determination of fasting blood glucose and serum fructosamine concentrations will be collected at baseline (Visit 2) and the end of Period 1 (Visit 3) and Period 2 (Visit 4). Blood samples will be analyzed by a central laboratory.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Glycemic Control and User Acceptability of the BD Ultra-Fine Nano 4 mm x 32G Pen Needle for Injection of Long-acting or Basal Insulin Doses Above 40 Units|
|Study Start Date :||March 2011|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Experimental: Nano: 4mm x 32G Pen Needle
Subjects will use the 4mm x 32G pen needle for all self-administered pen injections of diabetes medications during the assigned three week study period.
Device: 4 mm x 32G pen needle (Nano)
The pen needle will be used to administer all pen-based diabetes medications. When using the 4mm Nano pen needle, subjects are directed to hold the pen device at a 90 degree angle and perform the injection with no pinch-up.
Other Name: 4 mm x 32 G BD Ultra-Fine Nano pen needle
Experimental: Short: 8mm x 31G Pen Needle
Subjects will use the 8 mm x 31G pen needle for all self-administered pen injections of diabetes medications during the assigned three week study period.
Device: 8mm x 31G pen needle (Short)
The pen needle will be used to administer all pen-based diabetes medications. When using the 8mm Short pen needle, subjects are directed to use the pinch-up technique for injections in the abdomen and thigh, and no pinch-up at other injection sites. Subjects are to hold the pen device at a 90 degree angle.
Other Name: 8 mm x 31G BD Ultra-Fine Short insulin pen needle.
- Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine [ Time Frame: 3 weeks per pen needle ]The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.
- Glycemic Control as Measured by Fasting Blood Glucose [ Time Frame: 3 weeks per pen needle ]The measure of glycemic control will be the percent difference in fasting blood glucose (FBG) assessed at the end of Period 1 and Period 2. The average percent difference in FBG between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusted for baseline FBG. This outcome measure will be determined for the total subject population as well as for the subset of Lantus users.
- Percentage of Subjects With at Least One Leakage Event [ Time Frame: 3 weeks per pen needle ]Leakage will be assessed by the subject after any injections of long-acting insulin of greater than 40 units. Subjects will record in their study diary if they observed insulin leakage from the injection site.
- Relative Injection Pain [ Time Frame: End of Period 2 (six weeks) ]Subjects will complete a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with "as painful" and at each extreme with "much less painful (-75mm) and "much more painful (+75mm). The sign of each VAS score will be adjusted for the order of pen needle (PN) use, such that the 8mm short PN is always considered the reference.
- User Acceptability [ Time Frame: End of Period 1 (three weeks) and Period 2 (six weeks) ]After using each pen needle for three weeks, subjects will be asked to respond Yes or No to the question "Were the pen needles used for long acting insulin injections at doses greater than 40 units during this past study period acceptable to you?" This outcome measure will be determined for the total subject population as well as for the subset of Lantus users.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334606
|United States, Minnesota|
|International Diabetes Center (IDC)|
|Minneapolis, Minnesota, United States, 55416|
|United States, New Jersey|
|Comprehensive Clinical Research|
|Berlin, New Jersey, United States, 08009|
|BioPharma Services Inc.|
|Toronto, Ontario, Canada, M9L 3A2|
|Study Director:||Laurence J Hirsch, MD||BD Medical - Diabetes Care|