N/A
Completed N=274
Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
Diabetes Mellitus, Type 1 · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01231984 ↗
Enrolled (actual)
274
Serious AEs
3.1%
Results posted
Jun 2014
Primary outcomePrimary: Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) — 7.59; 7.46; 7.63; 7.59 HbA1c (%)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) |
7.59; 7.46; 7.63; 7.59; 7.78; 7.59 | — |
| PRIMARY Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) |
7.57; 7.45; 7.58; 7.54; 7.73; 7.51 | — |
| SECONDARY Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users |
7.77; 7.57; 7.76; 7.62; 7.98; 7.66 | — |
| SECONDARY Injection Pain Scores (4 mm vs. 8 mm) |
-31.53; -19.17 | <0.05 sig |
| SECONDARY Injection Pain Scores (4 mm vs. 12 mm) |
-27.72; 3.10 | <0.05 sig |
| SECONDARY Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. |
1; 2; 0 | — |
| SECONDARY Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. |
0; 0; 0 | — |
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'
Data sourced from ClinicalTrials.gov (NCT01231984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.