Clinical trial NCT01334606: Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
pen needle
basal insulin
long-acting insulin
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine
timeFrame: 3 weeks per pen needle
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center (IDC)
state: Minnesota
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Toronto
country: Canada
facility: BioPharma Services Inc.
state: Ontario
Study officials:
affiliation: BD Medical - Diabetes Care
name: Laurence J Hirsch, MD
role: STUDY_DIRECTOR
References:
citation: Hirsch LJ, Gibney MA, Li L, Berube J. Glycemic control, reported pain and leakage with a 4 mm x 32 G pen needle in obese and non-obese adults with diabetes: a post hoc analysis. Curr Med Res Opin. 2012 Aug;28(8):1305-11. doi: 10.1185/03007995.2012.709181. Epub 2012 Jul 18.
citation: Hirsch LJ, Gibney MA, Albanese J, Qu S, Kassler-Taub K, Klaff LJ, Bailey TS. Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes. Curr Med Res Opin. 2010 Jun;26(6):1531-41. doi: 10.1185/03007995.2010.482499.