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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is an open-label, randomized two period crossover study. Each subject's participation is expected to last about seven weeks and includes a brief enrolment period followed by two consecutive three week treatment periods (Period 1 and Period 2). In Period 1, subjects will use the first assigned study pen needle (either the 4mm Nano or the 8mm Short) to self-administer daily all their pen-based diabetes medications. Upon completion of Period 1, subjects will switch to the alternate pen needle for Period 2. The randomization schedule will determine the order of pen needle use. Blood samples for determination of fasting blood glucose and serum fructosamine concentrations will be collected at baseline (Visit 2) and the end of Period 1 (Visit 3) and Period 2 (Visit 4). Blood samples will be analyzed by a central laboratory.

Official Title
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Evaluation of Glycemic Control and User Acceptability of the BD Ultra-Fine Nano 4 mm x 32G Pen Needle for Injection of Long-acting or Basal Insulin Doses Above 40 Units

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: 4 mm x 32G pen needle (Nano)
* Device: 8mm x 31G pen needle (Short)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nano: 4mm x 32G Pen Needle<br>Subjects will use the 4mm x 32G pen needle for all self-administered pen injections of diabetes medications during the assigned three week study period. | Device: 4 mm x 32G pen needle (Nano)<br>* The pen needle will be used to administer all pen-based diabetes medications. When using the 4mm Nano pen needle, subjects are directed to hold the pen device at a 90 degree angle and perform the injection with no pinch-up.<br>* Other names: 4 mm x 32 G BD Ultra-Fine Nano pen needle;|
| Experimental: Short: 8mm x 31G Pen Needle<br>Subjects will use the 8 mm x 31G pen needle for all self-administered pen injections of diabetes medications during the assigned three week study period. | Device: 8mm x 31G pen needle (Short)<br>* The pen needle will be used to administer all pen-based diabetes medications. When using the 8mm Short pen needle, subjects are directed to use the pinch-up technique for injections in the abdomen and thigh, and no pinch-up at other injection sites. Subjects are to hold the pen device at a 90 degree angle.<br>* Other names: 8 mm x 31G BD Ultra-Fine Short insulin pen needle.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine | 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 users. | 3 weeks per pen needle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, pen needle, basal insulin, long-acting insulin