Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles

NCT ID: NCT00928057

Last Updated: 2010-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-11-30

Brief Summary

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.

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

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

4mm x 32G pen needle

Intervention Type: DEVICE

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.

8mm x 31G pen needle

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

4mm x 32G pen needle

Intervention Type: DEVICE

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.

5mm x 31G pen needle

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

BD Ultra-Fine™ Nano pen needle, Catalog number 320122; BD Ultra-Fine™ Short pen needle, Catalog number 320109; BD Ultra-Fine™ Mini pen needle, Catalog Number 320119

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

BD Medical

Principal Investigators

Kenneth Kassler-Taub, MD

Role: STUDY_DIRECTOR

Becton, Dickinson and Company

Locations

Radiant Research

Birmingham, Alabama, United States

AMCR Institute, Inc.

Escondido, California, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Countries

United States

References

Hirsch LJ, Gibney MA, Albanese J, Qu S, Kassler-Taub K, Klaff LJ, Bailey TS. 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 Jun;26(6):1531-41. doi: 10.1185/03007995.2010.482499.

Reference Type: RESULT

PMID: 20429832 (View on PubMed)

Hirsch LJ, Gibney MA, Li L, Berube J. Glycemic control, reported pain and leakage with a 4 mm x 32 G pen needle in obese and non-obese adults with diabetes: a post hoc analysis. Curr Med Res Opin. 2012 Aug;28(8):1305-11. doi: 10.1185/03007995.2012.709181. Epub 2012 Jul 18.

Reference Type: DERIVED

PMID: 22762347 (View on PubMed)

Other Identifiers

BDDC-08-011

Identifier Type: -

Identifier Source: org_study_id