Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01334606

Run by

Becton, Dickinson and Company

People needed

21

Starts

2011-03-01

Expected to finish

2011-06-01

Last updated by the study team

2022-03-10

Who can join

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

You may qualify if…

• Diagnosed with type 2 diabetes mellitus
• Have been using a pen device for all diabetes or diabetes-related medications for at least one month prior to screening
• Use a pen device to self-administer greater than 40 units of Lantus, Levemir, and/or NPH in one or more single injections. For split doses, at least one of the injections must deliver more than 40 units.
• Documented hemoglobin A1c (HbA1c) from 5.5% to 9.5%, inclusive
• Self monitor blood glucose at once daily with a memory blood glucose meter, and willing do so at least twice per day for the duration of the study
• On a stable diabetes regimen (insulin and non-insulin meds, diet and exercise) for at least 1 month prior to screening
• Able to read, write and follow instructions in English

You may not qualify if…

• Current administration of insulin with a pump.
• Current use a syringe to inject insulin or any diabetes-related medication
• Participation in clinical study BDDC-08-011 or DBC-10-SQUIR05
• History of intravenous drug abuse.
• Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Investigator, would place the subject at risk or potentially confound interpretation of the study results (i.e., recent history of ketoacidosis, hypoglycemic unawareness, etc).
• Pregnancy

Where it is running

• International Diabetes Center (IDC) — Minneapolis, Minnesota, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• BioPharma Services Inc. — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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