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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

4 mm x 32G pen needle (Nano)

8mm x 31G pen needle (Short)

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, pen needle, basal insulin, long-acting insulin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

International Diabetes Center (IDC)
Comprehensive Clinical Research
BioPharma Services Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Nano: 4mm x 32G Pen Needle

Short: 8mm x 31G Pen Needle

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01334606

First Posted

April 8, 2011

Last Updated

February 28, 2022

Sponsor

Becton, Dickinson and Company

1. Study Identification

Unique Protocol Identification Number

NCT01334606

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated due to unanticipated recruitment difficulties.

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Becton, Dickinson and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nano: 4mm x 32G Pen Needle

Arm Type

Experimental

Arm Description

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.

Arm Title

Short: 8mm x 31G Pen Needle

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

4 mm x 32G pen needle (Nano)

Other Intervention Name(s)

4 mm x 32 G BD Ultra-Fine Nano pen needle

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

8mm x 31G pen needle (Short)

Other Intervention Name(s)

8 mm x 31G BD Ultra-Fine Short insulin pen needle.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine

Description

Time Frame

3 weeks per pen needle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurence J Hirsch, MD

Organizational Affiliation

BD Medical - Diabetes Care

Official's Role

Study Director

Facility Information:

Facility Name

International Diabetes Center (IDC)

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

BioPharma Services Inc.

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9L 3A2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

22762347

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.

Results Reference

background

PubMed Identifier

20429832

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.

Results Reference

background

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

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