Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00928057

Run by

Becton, Dickinson and Company

People needed

173

Starts

2009-06-01

Expected to finish

2009-11-01

Last updated by the study team

2010-10-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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