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

NCT01231984 | Completed Results

• 1 other identifier: DBC-10-SQUIR05
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 10

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

diabetes; obesity; hypoglycemia; hyperglycemia; pen needle

Outcome Measures

Primary Outcomes (2)

• Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)

  Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7).

  Over each 12 week study period

• Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)

  Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7).

  Over each 12 week study period

Secondary Outcomes (5)

• Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users

  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.

• Injection Pain Scores (4 mm vs. 8 mm)

  At the end of Study Period 2

• Injection Pain Scores (4 mm vs. 12 mm)

  At the end of Study Period 2

• Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.

  During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)

• Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.

  During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)

Study Arms (2)

4 mm vs. 8 mm

EXPERIMENTAL

Subjects randomized to this study arm first used either the 4 mm x 32G Pen Needle or the 8mm x 31G Pen Needle for 12 weeks (Period 1), then switched to the alternate pen needle (PN) for another 12 weeks (Period 2). Order of PN use was randomly determined.

Device: 4 mm x 32G Pen Needle; Device: 8mm x 31G Pen Needle

4 mm vs. 12.7 mm

EXPERIMENTAL

Subjects randomized to this study arm first used either the 4 mm x 32G Pen Needle or the 12.7mm x 29G Pen Needle (PN) for 12 weeks (Period 1), then switched to the alternate PN for another 12 weeks (Period 2). Order of PN use was randomly determined.

Device: 4 mm x 32G Pen Needle; Device: 12.7mm x 29G Pen Needle

Interventions

4 mm x 32G Pen Needle DEVICE

During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up.

Also known as: BD Ultra-Fine™ Nano pen needle, Catalog number 320122

4 mm vs. 12.7 mm; 4 mm vs. 8 mm

8mm x 31G Pen Needle DEVICE

During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.

Also known as: BD Ultra-Fine™ Short pen needle, Catalog number 320109

4 mm vs. 8 mm

12.7mm x 29G Pen Needle DEVICE

During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. When using the 12.7mm PN, subjects are instructed to insert either at an angle of 45 degrees, or to pinch up and hold the pen device at a 90 degree angle (straight in).

Also known as: BD Ultra-Fine™ Original pen needle, BD Catalog Number 328203

4 mm vs. 12.7 mm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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'

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (10)

AMCR Institute, Inc.

Escondido, California, 92026, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Springfield Diabetes and Endocrine Center

Springfield, Illinois, 62704, United States

Location

International Diabetes Center (IDC)

Minneapolis, Minnesota, 55416, United States

Location

Diabetes and Endocrine Associates

Omaha, Nebraska, 68131, United States

Location

The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37403, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Corporate Lane Internal Medicine and Research Center

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (2)

• 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.

  PMID: 20429833 BACKGROUND

• 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.

  PMID: 25662503 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Obesity; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laurence Hirsch, MD
• Organization: Becton Dickinson

Laurence_Hirsch@bd.com

201-847-6513

Study Officials

• Laurence Hirsch, MD

  BD Medical - Diabetes Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 19, 2024
• Results First Posted: June 27, 2014

Record last verified: 2024-08

Locations

US (10)