Diabetes Mellitus, Type 2NCT01334606
Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
A study testing 4 mm x 32G pen needle (Nano) and 8mm x 31G pen needle (Short) in people with Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 4 mm x 32G pen needle (Nano) and 8mm x 31G pen needle (Short)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
International Diabetes Center (IDC)
Minneapolis, Minnesota, 55416
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 4 mm x 32G pen needle (Nano), 8mm x 31G pen needle (Short)
- Keywords
- diabetes, pen needle, basal insulin, long-acting insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mm x 32G pen needle (Nano)Device
Also called 4 mm x 32 G BD Ultra-Fine Nano pen needle
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)Device
Also called 8 mm x 31G BD Ultra-Fine Short insulin pen needle.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 8mm x 31G pen needle (Short) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks per pen needle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: This study was terminated due to unanticipated recruitment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence J Hirsch, MD, Study director, BD Medical - Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334606
- Sponsor's protocol ID
- DBC-10-SQUIR04
- Status last verified
- Feb 2022
- First submitted
- 8 Apr 2011
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22762347Hirsch 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.
PubMed 20429832
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01334606
- Acronym / sponsor ID
- DBC-10-SQUIR04
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, pen needle, basal insulin, long-acting insulin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to unanticipated recruitment difficulties.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Posted 2 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano: 4mm x 32G Pen Needle | Experimental | Device: 4 mm x 32G pen needle (Nano)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. |
| Short: 8mm x 31G Pen Needle | Experimental | Device: 8mm x 31G pen needle (Short)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 mm x 32G pen needle (Nano)Also: 4 mm x 32 G BD Ultra-Fine Nano pen needleThe 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. | Device | Nano: 4mm x 32G Pen Needle |
| 8mm x 31G pen needle (Short)Also: 8 mm x 31G BD Ultra-Fine Short insulin pen needle.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. | Device | Short: 8mm x 31G Pen Needle |
Primary outcome
Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22762347Hirsch 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.
- Background: PubMed 20429832Hirsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence J Hirsch, MD study director
BD Medical - Diabetes Care
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 mm x 32G pen needle (Nano) and 8mm x 31G pen needle (Short) in people with Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine (time frame: 3 weeks per pen needle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334606, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.