Diabetes Mellitus, Type 1NCT00928057
Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
A study testing 4mm x 32G pen needle, 8mm x 31G pen needle and 5mm x 31G pen needle in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 4 sites in United States.
Trial summary
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- 4mm x 32G pen needle, 8mm x 31G pen needle and 5mm x 31G pen needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Nov 2009
- 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
- Insulin requiring diabetics (type 1 or type 2)
- Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
- 18 to 75 years of age, inclusive.
- Body Mass Index from 18 to 50 kg/m², inclusive.
- Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
- Largest single dose of insulin a day less than or equal to 40 units
Who cannot join
- Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).
- Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
- History of intravenous drug abuse (self-reported).
- Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
- Self-reported blood borne infection.
- Pregnant (from medical history only).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
Radiant Research
Birmingham, Alabama, 35209
AMCR Institute, Inc.
Escondido, California, 92026
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
About this study
Official title: Comparison of Glycemic Control Among Diabetics Using the 4mm x 32G BD Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).
The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
Read the detailed description
Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period.
Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.
Explanation of Visits and Timing of Assessments:
Visit 1:
- Screening
- Informed Consent
- Demographics
- Inclusion /Exclusion
- Hemoglobin A1c measurement (HbA1c)
Visit 2 (Baseline:)
- Insulin dose group assignment (Low dose or Regular dose)
- Randomization
- Fructosamine blood sample collected
- Dispense pen needle (PN) assigned first
Visit 3 (approximately 3 weeks after starting first PN)
- Pain rated by subject relative to baseline PN
- Review Adverse Events (AEs) and reported events of injection site leakage
- Fructosamine blood sample collected
- Dispense second assigned PN
Visit 4 (approximately 3 weeks after starting second PN):
- Review AEs and reported events of injection site leakage
- Fructosamine blood sample collected
- Pain rated relative to previously used PN
- Study Completion
- Being tested
- 4mm x 32G pen needle, 8mm x 31G pen needle, 5mm x 31G pen needle
- Keywords
- Pen Needle, Diabetes, Insulin, Glycemic, Pain, Fructosamine, Leakage, Hypoglycemia, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Pain, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4mm x 32G pen needleDevice
Also called BD Ultra-Fine™ Nano pen needle, Catalog number 320122
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.
8mm x 31G pen needleDevice
Also called BD Ultra-Fine™ Short pen needle, Catalog number 320109
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
5mm x 31G pen needleDevice
Also called BD Ultra-Fine™ Mini pen needle, Catalog Number 320119
For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up.
| Study group | Role | What they receive |
|---|---|---|
| 4 mm / 8 mm PN | Experimental | Subjects randomized to this study arm used either the 4mm PN or the 8mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined. Receives: Device: 4mm x 32G pen needle; Device: 8mm x 31G pen needle |
| 4 mm / 5 mm PN | Experimental | Subjects randomized to this study arm used either the 4mm PN or the 5mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined. Receives: Device: 4mm x 32G pen needle; Device: 5mm x 31G pen needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) Absolute Change in Fructosamine
Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:
Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)].
Measured: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
Secondary outcomes (4)
Percent Absolute Change in Fructosamine, by Dose Group
Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:
%|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)].
Measured: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
Number of Subjects With Severe Unexplained Hypoglycemic Events
Severe Unexplained Hypoglycemia is defined as an event in which the subject's blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.
Measured: During 3 weeks using each pen needle
Number of Subjects With Severe Unexplained Hyperglycemic Events
Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.
Measured: During 3 weeks using each pen needle
Relative Injection Pain Score Assessed by Subject
After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with "as painful", and at the extreme ends with "much less painful" (-75mm) and "much more painful" (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.
Measured: Visit 4: 18-24 days after starting 2nd pen needle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionNov 2009
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 1Studies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kenneth Kassler-Taub, MD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928057
- Sponsor's protocol ID
- BDDC-08-011
- Status last verified
- Sep 2010
- First submitted
- 24 Jun 2009
- Last updated
- 20 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20429832Hirsch 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 22762347
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycemic Control Among Diabetics Using the 4mm x 32G BD Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle
- ClinicalTrials.gov ID
- NCT00928057
- Acronym / sponsor ID
- BDDC-08-011
- Keywords
- Pen Needle, Diabetes, Insulin, Glycemic, Pain, Fructosamine, Leakage, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 20 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).
The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
Detailed description
Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period.
Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.
Explanation of Visits and Timing of Assessments:
Visit 1:
- Screening
- Informed Consent
- Demographics
- Inclusion /Exclusion
- Hemoglobin A1c measurement (HbA1c)
Visit 2 (Baseline:)
- Insulin dose group assignment (Low dose or Regular dose)
- Randomization
- Fructosamine blood sample collected
- Dispense pen needle (PN) assigned first
Visit 3 (approximately 3 weeks after starting first PN)
- Pain rated by subject relative to baseline PN
- Review Adverse Events (AEs) and reported events of injection site leakage
- Fructosamine blood sample collected
- Dispense second assigned PN
Visit 4 (approximately 3 weeks after starting second PN):
- Review AEs and reported events of injection site leakage
- Fructosamine blood sample collected
- Pain rated relative to previously used PN
- Study Completion
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 mm / 8 mm PN | Experimental | Device: 4mm x 32G pen needle, Device: 8mm x 31G pen needleSubjects randomized to this study arm used either the 4mm PN or the 8mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined. |
| 4 mm / 5 mm PN | Experimental | Device: 4mm x 32G pen needle, Device: 5mm x 31G pen needleSubjects randomized to this study arm used either the 4mm PN or the 5mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Insulin requiring diabetics (type 1 or type 2)
- Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
- 18 to 75 years of age, inclusive.
- Body Mass Index from 18 to 50 kg/m², inclusive.
- Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
Key exclusion criteria (6 listed)
- Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).
- Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
- History of intravenous drug abuse (self-reported).
- Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
- Self-reported blood borne infection.
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 |
|---|---|---|
| 4mm x 32G pen needleAlso: BD Ultra-Fine™ Nano pen needle, Catalog number 320122For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up. | Device | 4 mm / 5 mm PN, 4 mm / 8 mm PN |
| 8mm x 31G pen needleAlso: BD Ultra-Fine™ Short pen needle, Catalog number 320109For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites. | Device | 4 mm / 8 mm PN |
| 5mm x 31G pen needleAlso: BD Ultra-Fine™ Mini pen needle, Catalog Number 320119For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up. | Device | 4 mm / 5 mm PN |
Primary outcome
Percent (%) Absolute Change in Fructosamine
Time frame: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula: Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)].
4 secondary outcomes
Percent Absolute Change in Fructosamine, by Dose Group
Time frame: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
Number of Subjects With Severe Unexplained Hypoglycemic Events
Time frame: During 3 weeks using each pen needle
Number of Subjects With Severe Unexplained Hyperglycemic Events
Time frame: During 3 weeks using each pen needle
Relative Injection Pain Score Assessed by Subject
Time frame: Visit 4: 18-24 days after starting 2nd pen needle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Derived from this study: 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.
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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.
Kenneth Kassler-Taub, MD study director
Becton, Dickinson and Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4mm x 32G pen needle, 8mm x 31G pen needle and 5mm x 31G pen needle in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 4 sites in United States.
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 6 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: finished, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 20 Oct 2010). 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?
Percent (%) Absolute Change in Fructosamine (time frame: 3 weeks per pen needle, from visit 2-3 and visit 3-4.). 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 NCT00928057, 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 20 Oct 2010.