Sansum Diabetes Research Institute, Santa Barbara, California 93105, USA.
Diabetes Technol Ther. 2012 Nov;14(11):997-1001. doi: 10.1089/dia.2012.0101. Epub 2012 Oct 9.
This pilot trial was designed to determine if an optimal dose of Technosphere(®) insulin (TI) inhalation powder (MannKind Corp., Valencia, CA) could be used regardless of variation in meal carbohydrate (CHO) content.
In total, eight subjects (seven men, one woman) with type 2 diabetes were enrolled. Subjects underwent dose optimization meal challenge (MC) visits (100% CHO) and MCs with varied CHO meal contents (50%, 200%, and 0% calculated CHOs). Primary end point was change in postprandial glucose (PPG) excursions. Baseline demographics were 60±7 years of age, diabetes duration of 12.3±4.27 years, hemoglobin A1c (A1C) of 7.82±1.04%, and body mass index of 31.3±5.48 kg/m(2).
Maximum mean PPG excursions for the nominal 100% CHO meals were -13±15 mg/dL for breakfast (B) and -14±15 mg/dL for lunch (L), similar to those after 50% CHO meals (B, -17±16 mg/dL; L, +14±10 mg/dL). The largest excursions occurred during 200% CHO meals and remained below American Diabetes Association targets (B, +19±16 mg/dL; L, +32±29 mg/dL). During 15 of the MCs, subjects took their usual TI dose and then had no meal (0% CHO). For the 0% CHO MCs, the largest mean PPG excursion were -33±9 mg/dL at 60 min (B) and -31±10 mg/dL at 60 and 90 min (L). Mean A1C dropped from 7.82±1.04% at the Week 1 visit to 6.18±0.46% (P=0.00091) at the Week 19 visit.
Results in eight patients suggest that once an optimal dose of TI is determined, type 2 diabetes patients can ingest meals with a wide range of CHO content or even skip meals without severe hypoglycemia. During this pilot study TI therapy improved A1C by -1.63% (P=0.00091) during 19 weeks of treatment.
本试验旨在确定 MannKind 公司生产的 Technosphere®胰岛素吸入粉（TI）的最佳剂量是否可以在不考虑膳食碳水化合物（CHO）含量变化的情况下使用。
共有 8 名 2 型糖尿病患者（7 名男性，1 名女性）入组。受试者接受了优化剂量的餐挑战（MC）访问（100%CHO）和不同 CHO 膳食含量的 MC（50%、200%和 0%计算 CHOs）。主要终点是餐后血糖（PPG）变化。基线人口统计学特征为 60±7 岁，糖尿病病程 12.3±4.27 年，糖化血红蛋白（A1C）7.82±1.04%，体重指数 31.3±5.48kg/m²。
100%CHO 膳食的最大平均 PPG 变化为早餐（B）-13±15mg/dL，午餐（L）-14±15mg/dL，与 50%CHO 膳食相似（B，-17±16mg/dL；L，+14±10mg/dL）。最大的变化发生在 200%CHO 膳食期间，仍低于美国糖尿病协会的目标（B，+19±16mg/dL；L，+32±29mg/dL）。在 15 次 MC 中，受试者服用了他们通常的 TI 剂量，然后没有进食（0%CHO）。对于 0%CHO MC，最大的平均 PPG 变化为 60min 时-33±9mg/dL（B）和 60min 和 90min 时-31±10mg/dL（L）。平均 A1C 从第 1 周就诊时的 7.82±1.04%降至第 19 周就诊时的 6.18±0.46%（P=0.00091）。
8 名患者的结果表明，一旦确定了 TI 的最佳剂量，2 型糖尿病患者可以摄入 CHO 含量广泛的膳食，甚至可以不进食而不会发生严重的低血糖。在这项初步研究中，TI 治疗在 19 周的治疗中使 A1C 降低了-1.63%（P=0.00091）。
