Clinical Evaluation of BD NEXT Pen Needle

Completed

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

In brief

This prospective, multi-center, 2 period cross-over study is designed to determine if people who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle (PN) in comparison with currently marketed pen needles of the same or similar gauge and length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN each for one week in a randomly assigned sequence, and will be asked to evaluate and compare characteristics of the BD NEXT pen needle versus their usual pen needle when used for all their pen injections performed at home. Since injection experience may vary according to the type of pen device used, equal numbers of subjects will be recruited who are users of three of the most commonly used insulin pen injectors.

Key facts

Study ID

NCT01852136

Run by

Becton, Dickinson and Company

People needed

217

Starts

2012-09-01

Expected to finish

2012-12-01

Last updated by the study team

2017-02-09

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Type 1 or Type 2 diabetes.
• Currently self-injects insulin with a pen device at least once daily, and doing so for at least two months prior to enrollment.
• One or more daily insulin doses injected with the pen device must be > 10 units
• The insulin pen being used by the subject for the daily dose of > 10 units must be one of the three currently marketed pens: sanofi-aventis SoloSTAR, Lilly KwikPen, or Novo Nordisk FlexPen
• Using a pen needle that is either 4, 5, 6, or 8 mm length, and either 31 or 32 gauge.
• Willing to use the assigned study needles for all pen injections (including insulin and any other pen-based medications).
• Willing to keep their diabetes medications, diet, and exercise the same during the study.
• Able to read, write and follow instructions in English.
• Able and willing to provide informed consent.
• The subject may also be using syringe and vial for some insulin doses, provided that at least one injection per day is done with an insulin pen and pen needle and is > 10 units.

You may not qualify if…

• Have previous knowledge of the details of this study or investigational products.
• Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Principal Investigator or Sub-Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (e.g., recent history of ketoacidosis, hypoglycemic unawareness, etc.).
• Currently participating in any other clinical investigation that conflicts with this one, or who have participated in a study with the same indication within the prior 30 days that the Principal Investigator or Sub-Investigator believes will conflict with outcomes or ability of the subject to complete all activities required in this study.
• Currently using either the Pic Indolor (Artsana) Insupen Sensitive 8 mm X 32G pen needle or the Pic Indolor (Artsana) Insupen Sensitive 6mm X 32G pen needle.
• History of intravenous drug use (self-reported).
• Employee, contractor or consultant to any company that manufactures pen needles, including BD.
• Pregnant (self-reported).

Where it is running

• Physicians Research Center — Toms River, New Jersey, United States
• Mountain Diabetes and Endocrine Center — Asheville, North Carolina, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Corporation Lane Internal Medicine and Research Center — Virginia Beach, Virginia, United States
• LMC Endocrinology Center — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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