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NCT01334606 · ClinicalTrials.gov registry record · NA
Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
A NA study, sponsored by Becton, Dickinson and Company.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT01334606: Clinical Trial NA study, sponsored by Becton, Dickinson and Company.
NCT01334606 is a NA study that was terminated before completion, run by Becton, Dickinson and Company. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334606, a NA study, was terminated before completion, sponsored by Becton, Dickinson and Company.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or more single daily injections of greater than 40 units of insulin. Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be enrolled so as to allow for pre-specified analysis of this subgroup.
Primary Outcome
The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus use
Interventions
- DEVICE 4 mm x 32G pen needle (Nano)
- DEVICE 8mm x 31G pen needle (Short)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-06 |
| Phase | NA |
Why NCT01334606 stopped before completion
NCT01334606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which 4 mm x 32G pen needle (Nano) is the first listed.
NCT01334606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01334606 about?
NCT01334606 is a clinical study titled "Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units". The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or more single daily inject...
What is the current status of trial NCT01334606?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2011-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01334606?
The interventions under investigation include: 4 mm x 32G pen needle (Nano) (DEVICE), 8mm x 31G pen needle (Short) (DEVICE).
Who is sponsoring clinical trial NCT01334606?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334606's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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