Matfin Glenn, Van Brunt Kate, Zimmermann Alan G, Threlkeld Rebecca, Ignaut Debra A
International Diabetes Center, Minneapolis, MN, USA.
Eli Lilly and Company, Windlesham, Surrey, UK.
J Diabetes Sci Technol. 2015 Apr 21;9(5):1071-9. doi: 10.1177/1932296815583059.
This 4-week, phase 3b, multicenter, open-label, single-arm, outpatient study demonstrated the safe and effective use of the dulaglutide single-dose pen containing 0.5 mL of placebo for subcutaneous injection in injection-naïve adult patients with type 2 diabetes (T2D), with A1C ≤ 8.5% (69 mmol/mol), BMI ≥ 23 kg/m2 and ≤ 45 kg/m(2).
Patients completed a modified self-injecting subscale of the Diabetes Fear of Injecting and Self-Testing Questionnaire (mD-FISQ) and were trained to self-inject with the single-dose pen. Patients completed the initial self-injection at the site, injected at home for 2 subsequent weeks, and returned to the site for the final injection. The initial and final self-injections were evaluated for success; the final (initial) self-injection success rate was the primary (secondary) outcome measure, and the primary (secondary) objective was to demonstrate this success rate as being significantly greater than 80%. Patients recorded their level of pain after each injection. After the final injection, patients completed the mD-FISQ and the Medication Delivery Device Assessment Battery (MDDAB) to assess their perceptions of the single-dose pen, including ease of use and experience with the device.
Among 211 patients (mean age: 61 years), the primary objective was met, with a final injection success rate of 99.1% (95% CI: 96.6% to 99.7%). Among 214 patients, the initial injection success rate was 97.2% (95% CI: 94.0% to 98.7%), meeting the key secondary objective. Overall, most patients (>96%) found the device easy to use, were satisfied with the device, and would be willing to continue to use the single-dose pen after the study. There was a significant reduction (P < .001) from baseline to study end in patients' fear of self-injecting, as measured by the mD-FISQ.
The dulaglutide single-dose pen was found to be a safe and effective device for use by patients with T2D who were injection-naïve. A positive injection experience is an important factor for patients and providers when initiating injectable therapy.
这项为期4周的3b期多中心开放标签单臂门诊研究，证明了含0.5 mL安慰剂的度拉糖肽单剂量笔，用于未接受过注射治疗、糖化血红蛋白（A1C）≤8.5%（69 mmol/mol）、体重指数（BMI）≥23 kg/m²且≤45 kg/m²的2型糖尿病（T2D）成年患者皮下注射时的安全性和有效性。
患者完成了糖尿病注射与自我检测恐惧问卷（mD-FISQ）的改良自我注射子量表，并接受了单剂量笔自我注射的培训。患者在研究地点完成首次自我注射，随后在家中注射2周，然后返回研究地点进行最后一次注射。评估首次和最后一次自我注射是否成功；最后（首次）自我注射成功率是主要（次要）结局指标，主要（次要）目标是证明该成功率显著高于80%。患者记录每次注射后的疼痛程度。最后一次注射后，患者完成mD-FISQ和药物递送装置评估量表（MDDAB），以评估他们对单剂量笔的看法，包括使用便利性和对该装置的体验。
在211名患者（平均年龄：61岁）中，达到了主要目标，最后一次注射成功率为99.1%（95%置信区间：96.6%至99.7%）。在214名患者中，首次注射成功率为97.2%（95%置信区间：94.0%至98.7%），达到了关键次要目标。总体而言，大多数患者（>96%）认为该装置易于使用，对该装置满意，并愿意在研究结束后继续使用单剂量笔。根据mD-FISQ测量，从基线到研究结束，患者对自我注射的恐惧显著降低（P <.001）。
度拉糖肽单剂量笔被发现是一种安全有效的装置，适用于未接受过注射治疗的T2D患者。积极的注射体验是患者和医护人员开始注射治疗时的一个重要因素。
