Thompson R G, Peterson J, Gottlieb A, Mullane J
Amylin Pharmaceuticals, Inc., San Diego, California 92121, USA.
Diabetes. 1997 Apr;46(4):632-6.
The effects of subcutaneous administration of 10, 30, or 100 microg q.i.d. pramlintide, an analog of human amylin, on plasma glucose regulation in patients with IDDM were evaluated in a multicenter trial. The plasma glucose response to a Sustacal test meal was significantly reduced compared with placebo both after 1 week and after 2 weeks of administration of 30 or 100 microg pramlintide. In addition, 24-h mean plasma glucose concentrations were significantly lowered in patients receiving 30 microg of pramlintide for 2 weeks compared with placebo, while the 100-microg pramlintide dose did not reach statistical significance for the 24-h glucose profiles. At 10 microg, pramlintide had no effect on the 24-h glucose profile or on the plasma glucose response to a Sustacal test meal. The reduction in 24-h glucose concentrations and glucose concentrations after the Sustacal test meal observed at the 30-microg pramlintide dose was not accompanied by an increased incidence of hypoglycemic events. The most frequent adverse events were dose-related and involved transient upper gastrointestinal symptoms. A majority (>80%) of the patients who reported these adverse events during week 1 did not report them in week 2. These data indicate that pramlintide effectively reduces plasma glucose concentrations as reflected in both a 24-h glucose profile and a Sustacal test meal while maintaining an acceptable safety profile.
在一项多中心试验中，评估了皮下注射10、30或100微克每日四次的普兰林肽（一种人胰淀素类似物）对胰岛素依赖型糖尿病（IDDM）患者血浆葡萄糖调节的影响。与安慰剂相比，在给予30或100微克普兰林肽1周和2周后，对Sustacal试验餐的血浆葡萄糖反应均显著降低。此外，与安慰剂相比，接受30微克普兰林肽治疗2周的患者24小时平均血浆葡萄糖浓度显著降低，而100微克普兰林肽剂量在24小时血糖曲线方面未达到统计学显著性。在10微克时，普兰林肽对24小时血糖曲线或对Sustacal试验餐的血浆葡萄糖反应没有影响。在30微克普兰林肽剂量下观察到的24小时葡萄糖浓度和Sustacal试验餐后葡萄糖浓度的降低，并未伴随低血糖事件发生率的增加。最常见的不良事件与剂量相关，涉及短暂的上消化道症状。在第1周报告这些不良事件的大多数患者（>80%）在第2周未报告。这些数据表明，普兰林肽能有效降低血浆葡萄糖浓度，这在24小时血糖曲线和Sustacal试验餐中均有体现，同时保持了可接受的安全性。
