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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 is a NA study that was terminated before completion, run by Becton, Dickinson and Company. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01334606
The ClinicalTrials.gov registry entry for NCT01334606 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Becton, Dickinson and Company, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 4 mm x 32G pen needle (Nano) is the first listed.
NCT01334606 reports 0 study locations.
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.
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