Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01231984

Run by

Becton, Dickinson and Company

People needed

293

Starts

2010-10-01

Expected to finish

2012-05-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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'

Where it is running

• AMCR Institute, Inc. — Escondido, California, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Springfield Diabetes and Endocrine Center — Springfield, Illinois, United States
• International Diabetes Center (IDC) — Minneapolis, Minnesota, United States
• Diabetes and Endocrine Associates — Omaha, Nebraska, United States
• The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mountain Diabetes and Endocrine Center — Asheville, North Carolina, United States
• University Diabetes and Endocrine Consultants — Chattanooga, Tennessee, United States
• Clinical Trials of Texas, Inc — San Antonio, Texas, United States
• Corporate Lane Internal Medicine and Research Center — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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