Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles

This study has been completed.
Sponsor:
Information provided by:
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT00928057
First received: June 24, 2009
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).

The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.


Condition Intervention
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Device: 4mm x 32G pen needle
Device: 8mm x 31G pen needle
Device: 5mm x 31G pen needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparison of Glycemic Control Among Diabetics Using the 4mm x 32G BD Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent (%) Absolute Change in Fructosamine [ Time Frame: 3 weeks per pen needle, from visit 2-3 and visit 3-4. ] [ Designated as safety issue: No ]

    Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:

    Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)].



Secondary Outcome Measures:
  • Percent Absolute Change in Fructosamine, by Dose Group [ Time Frame: 3 weeks per pen needle, from visit 2-3 and visit 3-4. ] [ Designated as safety issue: No ]

    Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:

    %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)].


  • Number of Subjects With Severe Unexplained Hypoglycemic Events [ Time Frame: During 3 weeks using each pen needle ] [ Designated as safety issue: Yes ]
    Severe Unexplained Hypoglycemia is defined as an event in which the subject's blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.

  • Number of Subjects With Severe Unexplained Hyperglycemic Events [ Time Frame: During 3 weeks using each pen needle ] [ Designated as safety issue: Yes ]
    Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.

  • Relative Injection Pain Score Assessed by Subject [ Time Frame: Visit 4: 18-24 days after starting 2nd pen needle ] [ Designated as safety issue: No ]
    After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with "as painful", and at the extreme ends with "much less painful" (-75mm) and "much more painful" (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.


Enrollment: 173
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 mm / 8 mm PN
Subjects randomized to this study arm used either the 4mm PN or the 8mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined.
Device: 4mm x 32G pen needle
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.
Other Name: BD Ultra-Fine™ Nano pen needle, Catalog number 320122
Device: 8mm x 31G pen needle
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
Other Name: BD Ultra-Fine™ Short pen needle, Catalog number 320109
Experimental: 4 mm / 5 mm PN
Subjects randomized to this study arm used either the 4mm PN or the 5mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined.
Device: 4mm x 32G pen needle
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.
Other Name: BD Ultra-Fine™ Nano pen needle, Catalog number 320122
Device: 5mm x 31G pen needle
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up.
Other Name: BD Ultra-Fine™ Mini pen needle, Catalog Number 320119

Detailed Description:

Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period.

Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.

Explanation of Visits and Timing of Assessments:

Visit 1:

  • Screening
  • Informed Consent
  • Demographics
  • Inclusion /Exclusion
  • Hemoglobin A1c measurement (HbA1c)

Visit 2 (Baseline:)

  • Insulin dose group assignment (Low dose or Regular dose)
  • Randomization
  • Fructosamine blood sample collected
  • Dispense pen needle (PN) assigned first

Visit 3 (approximately 3 weeks after starting first PN)

  • Pain rated by subject relative to baseline PN
  • Review Adverse Events (AEs) and reported events of injection site leakage
  • Fructosamine blood sample collected
  • Dispense second assigned PN

Visit 4 (approximately 3 weeks after starting second PN):

  • Review AEs and reported events of injection site leakage
  • Fructosamine blood sample collected
  • Pain rated relative to previously used PN
  • Study Completion
  Eligibility

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

Inclusion Criteria:

  • Insulin requiring diabetics (type 1 or type 2)
  • Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
  • 18 to 75 years of age, inclusive.
  • Body Mass Index from 18 to 50 kg/m², inclusive.
  • Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
  • Largest single dose of insulin a day less than or equal to 40 units

Exclusion Criteria:

  • Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).
  • Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
  • History of intravenous drug abuse (self-reported).
  • Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
  • Self-reported blood borne infection.
  • Pregnant (from medical history only).
  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: NCT00928057

Locations
United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
United States, California
AMCR Institute, Inc.
Escondido, California, United States, 92026
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Washington
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
Study Director: Kenneth Kassler-Taub, MD Becton, Dickinson and Company
  More Information

Publications:
Hirsch LJ, Gibney MA, Albanese J, et al. Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes. Curr Med Res Opin 2010; 26 (6): 1531-1541.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kenneth Kassler-Taub / WW Vice President / Medical Affairs, BD Medical
ClinicalTrials.gov Identifier: NCT00928057     History of Changes
Other Study ID Numbers: BDDC-08-011
Study First Received: June 24, 2009
Results First Received: August 12, 2010
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Becton, Dickinson and Company:
Pen Needle
Diabetes
Insulin
Glycemic
Pain
Fructosamine
Leakage
Hypoglycemia
Hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014