Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nano: 4mm x 32G Pen Needle 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)
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.
Other Names:
|
| Experimental: Short: 8mm x 31G Pen Needle 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)
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine [3 weeks per pen needle]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | International Diabetes Center (IDC) | Minneapolis | Minnesota | United States | 55416 |
| 2 | Comprehensive Clinical Research | Berlin | New Jersey | United States | 08009 |
| 3 | BioPharma Services Inc. | Toronto | Ontario | Canada | M9L 3A2 |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
- Study Director: Laurence J Hirsch, MD, BD Medical - Diabetes Care
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- DBC-10-SQUIR04
Study Results
Participant Flow
| Recruitment Details | Recruitment began at three medical research centers in March 2011. Due to slow enrolment, the study was terminated after 9 weeks. |
|---|---|
| Pre-assignment Detail | There is no information for this section. |
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared. |
| Period Title: Overall Study | |
| STARTED | 21 |
| COMPLETED | 3 |
| NOT COMPLETED | 18 |
Baseline Characteristics
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention. |
| Overall Participants | 21 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
59.1
(9.45)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
9
42.9%
|
| Male |
12
57.1%
|
| Region of Enrollment (participants) [Number] | |
| United States |
16
76.2%
|
| Canada |
5
23.8%
|
Outcome Measures
| Title | Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine |
|---|---|
| Description | 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. |
| Time Frame | 3 weeks per pen needle |
Outcome Measure Data
| Analysis Population Description |
|---|
| No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | Due to early termination of the study, only 3 subjects completed both study periods. Analysis of the primary outcome measure requires FRU data from both study periods. Due to the lack of sufficient data, no analysis was performed. |
| Measure Participants | 0 |
Adverse Events
| Time Frame | Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | All Study Participants | 4mmx32G Pen Needle | 8mmx31G Pen Needle | |||
| Arm/Group Description | This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product. | Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2 | Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2 | |||
All Cause Mortality |
||||||
| All Study Participants | 4mmx32G Pen Needle | 8mmx31G Pen Needle | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| All Study Participants | 4mmx32G Pen Needle | 8mmx31G Pen Needle | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/21 (4.8%) | 1/21 (4.8%) | 0/21 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Progressive Degeneration right knee | 1/21 (4.8%) | 1 | 1/21 (4.8%) | 1 | 0/21 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| All Study Participants | 4mmx32G Pen Needle | 8mmx31G Pen Needle | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/21 (42.9%) | 6/21 (28.6%) | 6/21 (28.6%) | |||
| Endocrine disorders | ||||||
| hypoglycemia | 6/21 (28.6%) | 15 | 3/21 (14.3%) | 3 | 5/21 (23.8%) | 12 |
| Gastrointestinal disorders | ||||||
| Diarrhea | 1/21 (4.8%) | 1 | 1/21 (4.8%) | 1 | 0/21 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Tennis Elbow | 1/21 (4.8%) | 1 | 1/21 (4.8%) | 1 | 0/21 (0%) | 0 |
| leg pain | 1/21 (4.8%) | 1 | 1/21 (4.8%) | 1 | 0/21 (0%) | 0 |
| Renal and urinary disorders | ||||||
| urinary tract infection | 1/21 (4.8%) | 1 | 0/21 (0%) | 0 | 1/21 (4.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Allergic rhinitis | 1/21 (4.8%) | 1 | 1/21 (4.8%) | 1 | 0/21 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Laurence J. Hirsch. Medical Director |
|---|---|
| Organization | BD Medical - Diabetes Care |
| Phone | 201-847-6513 |
| laurence_hirsch@bd.com |
- DBC-10-SQUIR04