Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units

This study has been terminated.
(This study was terminated due to unanticipated recruitment difficulties.)
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT01334606
First received: April 8, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Device: 4 mm x 32G pen needle (Nano)
Device: 8mm x 31G pen needle (Short)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Becton, Dickinson and Company:

Primary Outcome Measures:
  • Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine [ Time Frame: 3 weeks per pen needle ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Glycemic Control as Measured by Fasting Blood Glucose [ Time Frame: 3 weeks per pen needle ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus
  • Have been using a pen device for all diabetes or diabetes-related medications for at least one month prior to screening
  • Use a pen device to self-administer greater than 40 units of Lantus, Levemir, and/or NPH in one or more single injections. For split doses, at least one of the injections must deliver more than 40 units.
  • Documented hemoglobin A1c (HbA1c) from 5.5% to 9.5%, inclusive
  • Self monitor blood glucose at once daily with a memory blood glucose meter, and willing do so at least twice per day for the duration of the study
  • On a stable diabetes regimen (insulin and non-insulin meds, diet and exercise) for at least 1 month prior to screening
  • Able to read, write and follow instructions in English

Exclusion Criteria:

  • Current administration of insulin with a pump.
  • Current use a syringe to inject insulin or any diabetes-related medication
  • Participation in clinical study BDDC-08-011 or DBC-10-SQUIR05
  • History of intravenous drug abuse.
  • Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Investigator, would place the subject at risk or potentially confound interpretation of the study results (i.e., recent history of ketoacidosis, hypoglycemic unawareness, etc).
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334606

Locations
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
Canada, Ontario
BioPharma Services Inc.
Toronto, Ontario, Canada, M9L 3A2
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
Study Director: Laurence J Hirsch, MD BD Medical - Diabetes Care
  More Information

Publications:
Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT01334606     History of Changes
Other Study ID Numbers: DBC-10-SQUIR04
Study First Received: April 8, 2011
Results First Received: April 26, 2013
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Becton, Dickinson and Company:
diabetes
pen needle
basal insulin
long-acting insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014