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Clinical Evaluation of BD NEXT Pen Needle

NCT01852136 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 217

Last updated 2017-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1

Interventions

DEVICE

BD NEXT 31G x 5 mm pen needle

Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.

DEVICE

BD NEXT 31G x 8mm pen needle

Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.

DEVICE

BD NEXT 32G x 4mm pen needle

Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Laurence J Hirsch, MD · BD Medical-Diabetes Care

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852136 on ClinicalTrials.gov