Clinical trial NCT01231984: Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
Official title: Comparison of Glycemic Control in Obese Subjects With Diabetes Using the BD Ultra-Fine™ Nano 4mm x 32G Pen Needle, and Either the BD Ultra-Fine™ Short 8mm x 31G Pen Needle or the BD Ultra Fine™ 12.7mm x 29G Pen Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: diabetes
obesity
hypoglycemia
hyperglycemia
pen needle
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of longer pen needles may appeal to many diabetic patients as the shorter needle may be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in length are generally used for insulin injection in patients considered thin or normal weight, longer (12.7 mm) needles are still often prescribed for overweight or obese patients with diabetes. Since skin thickness is nearly constant across a range of body mass index (BMI), a clear rationale exists for the use of shorter needles in obese patients. (Gibney et al., CMRO 2010)

The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.

Detailed description: Each subject's participation is expected to last a total of 7 months and includes a screening visit, a three-week wash-in period (one week with each of the three different size pen needles) followed by two consecutive 12 week study periods. The purpose of the three week wash-in period is to minimize the number of dropouts during the following study periods by ensuring that subjects have experience using each of the three study needles and find them generally acceptable for use during the study.

Only subjects who complete the wash-in period and confirm their agreement to continue participating will be randomized into one of the two study arms. Subjects will be randomly assigned to use the BD Ultra-Fine™ 4mm pen needle and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle. The randomization will also specify which of the two study pen needles to be used first. Half of the study subjects will use the BD Ultra-Fine™ 4mm and BD Ultra-Fine™ 8mm pen needles (4mm/8mm arm) and the other half will use the BD Ultra-Fine™ 4mm and the BD Ultra-Fine™ 12.7mm pen needles (4mm/12.7mm arm). At the end of the first 12 week study period subjects will switch to the other assigned pen needle for the second and final study period.

Glycemic control (based on HbA1c concentrations) will be assessed at baseline and at the end of each 12 week study period.

Eligibility criteria: Inclusion Criteria:

* Insulin requiring diabetics (type 1 or type 2)
* Using a pen device for self-injection of all diabetes-related medications for at least two months prior to screening.
* 18 to 80 years of age, inclusive.
* Body Mass Index of at least 30 kg/m².
* Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
* Self-monitor blood glucose at least twice per day with a memory blood glucose meter, and willing to do so at least twice per day for the duration of the study
* On a stable diabetes treatment regimen (for example, no change to non-insulin therapies)for at least 2 months prior to screening
* Able to read, write and follow instructions in English or Spanish.

Exclusion Criteria:

* Administer insulin with a pump.
* Currently use a syringe to inject insulin or any other diabetes-related medication.
* Pregnancy.
* History of intravenous drug abuse.
* 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.)
* Participated in any one of the following clinical studies:

  * BDDC-08-011, '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'.
  * DBC-10-SQUIR04, 'Evaluation of Glycemic Control and User Acceptability of the BD Ultrafine Nano 4mm x 32G Pen Needle for Injection of Long-Acting or Basal Insulin Doses Above 40 Units'
  * DBC-10-EMRLD01, 'Design Validation of BD 5-bevel Pen Needles (4,5 and 8mm) in Subjects with Diabetes'

Primary outcomes:
measure: Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)
timeFrame: Over each 12 week study period
measure: Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)
timeFrame: Over each 12 week study period
Secondary outcomes:
measure: Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users
timeFrame: Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.
measure: Injection Pain Scores (4 mm vs. 8 mm)
timeFrame: At the end of Study Period 2
measure: Injection Pain Scores (4 mm vs. 12 mm)
timeFrame: At the end of Study Period 2
measure: Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.
timeFrame: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
measure: Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.
timeFrame: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute, Inc.
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Springfield
country: United States
facility: Springfield Diabetes and Endocrine Center
state: Illinois
city: Minneapolis
country: United States
facility: International Diabetes Center (IDC)
state: Minnesota
city: Omaha
country: United States
facility: Diabetes and Endocrine Associates
state: Nebraska
city: Hackensack
country: United States
facility: The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center
state: New Jersey
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: Virginia Beach
country: United States
facility: Corporate Lane Internal Medicine and Research Center
state: Virginia
Study officials:
affiliation: BD Medical - Diabetes Care
name: Laurence Hirsch, MD
role: STUDY_DIRECTOR
References:
citation: Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin. 2010 Jun;26(6):1519-30. doi: 10.1185/03007995.2010.481203.
citation: Bergenstal RM, Strock ES, Peremislov D, Gibney MA, Parvu V, Hirsch LJ. Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes. Mayo Clin Proc. 2015 Mar;90(3):329-38. doi: 10.1016/j.mayocp.2014.12.014. Epub 2015 Feb 7.