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

NCT01334606 | Terminated Results

• 1 other identifier: DBC-10-SQUIR04
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; pen needle; basal insulin; long-acting insulin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nano: 4mm x 32G Pen Needle

EXPERIMENTAL

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)

Short: 8mm x 31G Pen Needle

EXPERIMENTAL

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)

Interventions

4 mm x 32G pen needle (Nano) DEVICE

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.

Also known as: 4 mm x 32 G BD Ultra-Fine Nano pen needle

Nano: 4mm x 32G Pen Needle

8mm x 31G pen needle (Short) DEVICE

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.

Also known as: 8 mm x 31G BD Ultra-Fine Short insulin pen needle.

Short: 8mm x 31G Pen Needle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (3)

International Diabetes Center (IDC)

Minneapolis, Minnesota, 55416, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

BioPharma Services Inc.

Toronto, Ontario, M9L 3A2, Canada

Location

Related Publications (2)

• 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.

  PMID: 22762347 BACKGROUND

• 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.

  PMID: 20429832 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Laurence J. Hirsch. Medical Director
• Organization: BD Medical - Diabetes Care

laurence_hirsch@bd.com

201-847-6513

Study Officials

• Laurence J Hirsch, MD

  BD Medical - Diabetes Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 13, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 10, 2022
• Results First Posted: September 2, 2013

Record last verified: 2022-02

Locations

CA (1); US (2)