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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 8
- 主要终点
- Percent (%) Absolute Change in Fructosamine
研究概览
简要总结
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).
The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
详细描述
Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period.
Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.
Explanation of Visits and Timing of Assessments:
Visit 1:
- Screening
- Informed Consent
- Demographics
- Inclusion /Exclusion
- Hemoglobin A1c measurement (HbA1c)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin requiring diabetics (type 1 or type 2)
- •Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
- •18 to 75 years of age, inclusive.
- •Body Mass Index from 18 to 50 kg/m², inclusive.
- •Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
- •Largest single dose of insulin a day less than or equal to 40 units
排除标准
- •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.).
- •Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
- •History of intravenous drug abuse (self-reported).
- •Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
- •Self-reported blood borne infection.
- •Pregnant (from medical history only).
结局指标
主要结局
Percent (%) Absolute Change in Fructosamine
时间窗: 3 weeks per pen needle, from visit 2-3 and visit 3-4.
Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula: Percent absolute change in FRU, or %\|∆ FRU\|= 100\*\[FRU(4mm)-FRU(5 or 8mm)\]/\[FRU(5 or 8mm)\].
次要结局
- Percent Absolute Change in Fructosamine, by Dose Group(3 weeks per pen needle, from visit 2-3 and visit 3-4.)
- Number of Subjects With Severe Unexplained Hypoglycemic Events(During 3 weeks using each pen needle)
- Number of Subjects With Severe Unexplained Hyperglycemic Events(During 3 weeks using each pen needle)
- Relative Injection Pain Score Assessed by Subject(Visit 4: 18-24 days after starting 2nd pen needle)