Hausmann M, Dellweg S, Osborn C, Heinemann L, Buchwald A, Rosskamp R, Genova P, Heise T
Profil Institut für Stoffwechselforschung GmbH, Hellersbergstr. 9, Neuss, Germany.
Diabetes Obes Metab. 2006 Sep;8(5):574-80. doi: 10.1111/j.1463-1326.2006.00647.x.
This controlled proof-of-concept study investigated inhaled insulin (INH) as adjunctive therapy to existing oral antidiabetic agents in subjects with type 2 diabetes.
Twenty-four subjects with type 2 diabetes [19 men and 5 women, 56.1 +/- 6.6 years, body mass index 32.7 +/- 4.2 kg/m(2), glycosylated haemoglobin (HbA1c) 8.4 +/- 0.8% (mean +/- s.d.)] inadequately controlled by metformin and/or sulfonylureas were randomized to receive additional therapy with either INH administered preprandially using a metered-dose inhaler (MDI), or insulin glargine (GLA) injected subcutaneously at bedtime for 4 weeks. Both inhaled and injected insulin doses were titrated to predefined blood glucose (BG) targets.
INH and GLA improved metabolic control to a similar extent. Mean daily BG decreased by 2.8 mmol/l in the INH group (p < 0.001) and by 2.4 mmol/l in the GLA group (p < 0.001). Accordingly, fasting BG (-2.7 vs. -3.6 mmol/l for INH vs. GLA), preprandial- and 2-h postprandial BG, HbA1c (-1.23 vs. -1.05%), body weight (-1.9 vs. -2.3 kg) and serum fructosamine were similarly and significantly reduced in both groups (p < 0.05). Triglycerides decreased significantly with INH (-1.15 micromol/l; p < 0.001) but not with GLA [-0.52 micromol/l; not significant (NS)]. Incidence rates of adverse events did not differ significantly, and there were no indications of respiratory tract irritation.
In subjects with type 2 diabetes inadequately controlled by oral agents, preprandial administration of INH delivered by a MDI provided a comparable metabolic control to bedtime GLA and did not show any safety concerns during a 4-week treatment. These results warrant a more extensive investigation of preprandial treatment with INH in longer term studies.
本对照性概念验证研究调查了吸入胰岛素（INH）作为2型糖尿病患者现有口服抗糖尿病药物辅助治疗的效果。
24例2型糖尿病患者[19例男性和5例女性，年龄56.1±6.6岁，体重指数32.7±4.2kg/m²，糖化血红蛋白（HbA1c）8.4±0.8%（均值±标准差）]，使用二甲双胍和/或磺脲类药物血糖控制不佳，被随机分为两组，一组在餐前使用定量吸入器（MDI）吸入INH进行额外治疗，另一组在睡前皮下注射甘精胰岛素（GLA），为期4周。吸入和注射胰岛素的剂量均根据预定的血糖（BG）目标进行滴定。
INH和GLA在改善代谢控制方面程度相似。INH组平均每日血糖下降2.8mmol/L（p<0.001），GLA组下降2.4mmol/L（p<0.001）。相应地，两组的空腹血糖（INH组与GLA组分别为-2.7与-3.6mmol/L）、餐前和餐后2小时血糖、HbA1c（-1.23%与-1.05%）、体重（-1.9与-2.3kg）和血清果糖胺均有相似且显著的降低（p<0.05）。甘油三酯在INH治疗后显著下降（-1.15μmol/L；p<0.001），而GLA治疗后无明显下降[-0.52μmol/L；无显著性差异（NS）]。不良事件发生率无显著差异，且无呼吸道刺激迹象。
在口服药物血糖控制不佳的2型糖尿病患者中，餐前使用MDI吸入INH与睡前注射GLA在代谢控制方面相当，且在4周治疗期间未显示出任何安全问题。这些结果值得在长期研究中对餐前使用INH治疗进行更广泛的调查。
