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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01334606
• Other study ID #: DBC-10-SQUIR04
• Status: Terminated
• Phase: N/A
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: February 2022
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• 4 mm x 32G pen needle (Nano)
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.
• 8mm x 31G pen needle (Short)
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.

Locations

Country	Name	City	State
Canada	BioPharma Services Inc.	Toronto	Ontario
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	International Diabetes Center (IDC)	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

Hirsch LJ, Gibney MA, Li L, Bérubé J. Glycemic control, reported pain and leakage with a 4 mm × 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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