Becton, Dickinson and Company, Franklin Lakes, NJ 07417, USA.
Curr Med Res Opin. 2010 Jun;26(6):1531-41. doi: 10.1185/03007995.2010.482499.
Pen needles (PN) for subcutaneous insulin therapy have become smaller; 5 mm PNs are now the shortest in use. We evaluated the safety, efficacy and patient ratings of a new 4 mm x 32 gauge (G) PN.
Subjects with type 1 and type 2 diabetes and HbA1c 5.5% to 9.5% participated in a randomized non-inferiority cross-over trial, at four U.S. centers. Subjects used 4 mm x 32G PNs and either 5 mm x 31G PNs (4/5 mm) or 8 mm x 31G PNs (4/8 mm) in two, 3-week treatment periods; order of needle use was controlled. Subjects were either 'low dose' or 'regular dose' users (highest single insulin dose <or= 20 units and 21-40 units, respectively). Percent absolute change in serum fructosamine (% |Delta Fru|) was the primary endpoint; unexplained, severe hypo- or hyperglycemia was a secondary measure. Leakage at injection sites and pain measured by visual analog scale were tertiary measures. Equivalent glycemic control was defined á priori as % |Delta Fru| (including 95% CI) within 20%; 40 subjects per subgroup provides 90% power at alpha = 0.05.
The study was registered on clinicaltrials.gov (identifier: NCT00928057).
Of 173 subjects randomized, 168 completed the study, and 163 were included in the fructosamine analyses--83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. Subjects were 56% male, mean 52.6 yrs, 63% type 2. Baseline HbA1c = 7.5 +/- 1.0% and fructosamine 301 +/- 55.1 micromol/L. Mean % |Delta Fru| was 4.9% (95% CI 3.8, 6.0) and 5.5% (4.5, 6.4), respectively, for the 4/5 mm and 4/8 mm groups, meeting glycemic equivalence criteria; results were similar in both dose groups. The median |Delta Fru| was 11.0 micromol/L (8.0, 13.0) and 13.5 micromol/L (9.8, 18.0) for the 4/5 mm and 4/8 mm groups, respectively. Unexplained, severe hypo- and hyperglycemic episodes were infrequent and not different between PNs. The 4 mm PN was rated significantly less painful and preferred by approximately 2/3 of subjects (p < 0.01). All three PNs had similar reported injection site leakage.
The study was of relatively short duration, in adults in the U.S. Further trials in other patients (e.g., GLP-1 users, pediatrics, obese) should be performed.
The 4 mm x 32G PN provided equivalent glycemic control compared to 31G, 5 mm and 8 mm PNs with reduced pain, no difference in insulin leakage and was preferred by patients.
皮下胰岛素治疗用的针具（PN）已经变得更小；现在最短的是 5 毫米 PN。我们评估了一种新的 4 毫米 x 32 号（G）PN 的安全性、疗效和患者评分。
在美国四个中心，患有 1 型和 2 型糖尿病且 HbA1c 为 5.5%至 9.5%的受试者参加了一项随机非劣效性交叉试验。受试者在两个为期 3 周的治疗期内分别使用 4 毫米 x 32G PN 和 5 毫米 x 31G PN（4/5 毫米）或 8 毫米 x 31G PN（4/8 毫米）；使用顺序是受控的。受试者要么是“低剂量”要么是“常规剂量”使用者（最高单次胰岛素剂量≤20 单位和 21-40 单位）。血清果糖胺的绝对变化百分比（%|Delta Fru|）是主要终点；无法解释的严重低血糖或高血糖是次要测量指标。通过视觉模拟量表测量的注射部位渗漏和疼痛是三级测量指标。预先定义的等效血糖控制为%|Delta Fru|（包括 95%置信区间）在 20%以内；每组 40 名受试者，α = 0.05 时，具有 90%的功效。
该研究在 clinicaltrials.gov 上注册（标识符：NCT00928057）。
在 173 名随机分组的受试者中，168 名完成了研究，163 名受试者纳入果糖胺分析-分别有 83 名和 80 名受试者在 4/5 毫米和 4/8 毫米组中，83 名和 80 名受试者分别在 4/5 毫米和 4/8 毫米组中。受试者中 56%为男性，平均年龄为 52.6 岁，63%为 2 型。基线 HbA1c=7.5±1.0%，果糖胺 301±55.1 μmol/L。4/5 毫米和 4/8 毫米组的平均%|Delta Fru|分别为 4.9%（3.8，6.0）和 5.5%（4.5，6.4），符合血糖等效性标准；在两个剂量组中结果相似。4/5 毫米和 4/8 毫米组的中位数|Delta Fru|分别为 11.0 μmol/L（8.0，13.0）和 13.5 μmol/L（9.8，18.0）。无法解释的严重低血糖和高血糖事件发生频率较低，两组之间无差异。4 毫米 PN 被评为疼痛明显较轻，约有 2/3的受试者更喜欢（p<0.01）。所有三种 PN 的注射部位渗漏报告相似。
该研究持续时间相对较短，在美国的成年人中进行。应在其他患者（例如 GLP-1 使用者、儿科患者、肥胖患者）中进行进一步试验。
与 31G、5 毫米和 8 毫米 PN 相比，4 毫米 x 32G PN 提供了等效的血糖控制，同时疼痛减轻，胰岛素渗漏无差异，且患者更喜欢。
