Status:
COMPLETED
Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
NA
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 pe...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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'
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT01231984
Start Date
October 1 2010
End Date
May 1 2012
Last Update
September 19 2024
Active Locations (10)
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1
AMCR Institute, Inc.
Escondido, California, United States, 92026
2
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
3
Springfield Diabetes and Endocrine Center
Springfield, Illinois, United States, 62704
4
International Diabetes Center (IDC)
Minneapolis, Minnesota, United States, 55416