Standl E, Baumgartl H J, Füchtenbusch M, Stemplinger J
Institute of Diabetes Research and Department of Endocrinology, Academic Hospital Schwabing, Koelner Plate 1, Munich, Germany.
Diabetes Obes Metab. 1999 Jul;1(4):215-20. doi: 10.1046/j.1463-1326.1999.00021.x.
The present study investigated the effect of acarbose on insulin requirements and glycaemic control in patients with type 2 diabetes receiving exogenous insulin due to secondary failure of maximum dose sulphonylurea therapy.
A single-centre, double-blind, randomized, placebo-controlled study was performed in 48 type 2 diabetic patients with late-term failure following at least 3 years of sulphonylurea therapy requiring additional insulin therapy to determine the impact of acarbose on glycaemic control and insulin requirements. The primary end points were glycaemic response rate (responders being predefined as patients who achieve a decrease in HbA1c to less than 8% or a reduction by at least 15% as compared to the baseline values) and the daily insulin dose at 6 months. Secondary parameters assessed included postprandial changes in blood glucose, serum insulin and C-peptide during the treatment period.
There were significantly more responders in the acarbose-treated group compared with the placebo group (20/24 patients vs. 10/19 patients; p < 0.05). The mean daily insulin dose after 24 weeks of treatment was 16.4 +/- 10.1 IU in the acarbose group and 22.4 +/- 12.2 IU in the placebo group (mean +/- s.d.; p < 0.07). Postprandial increases in blood glucose, insulin and C-peptide were consistently lower in the acarbose-treated group than in the placebo group. For example, the mean increase in 2-h postprandial serum insulin remained almost unchanged in the acarbose group at the end of 24 weeks of treatment compared to an increase to 43 +/- 29 microU/ml (mean +/- s.d.) at the end of the study period for the placebo group.
The findings of this study suggest that the addition of acarbose to sulphonylurea/insulin combination therapy can improve glycaemic control in type 2 diabetic patients. Acarbose may also reduce insulin resistance and hyperinsulinaemia.
本研究调查了阿卡波糖对因最大剂量磺脲类药物治疗继发失效而接受外源性胰岛素治疗的2型糖尿病患者胰岛素需求量及血糖控制的影响。
对48例2型糖尿病患者进行了一项单中心、双盲、随机、安慰剂对照研究，这些患者在至少3年的磺脲类药物治疗后期失效，需要额外的胰岛素治疗，以确定阿卡波糖对血糖控制和胰岛素需求量的影响。主要终点为血糖反应率（反应者预先定义为糖化血红蛋白（HbA1c）降至低于8%或较基线值降低至少15%的患者）及6个月时的每日胰岛素剂量。评估的次要参数包括治疗期间餐后血糖、血清胰岛素和C肽的变化。
与安慰剂组相比，阿卡波糖治疗组的反应者明显更多（20/24例患者 vs. 10/19例患者；p < 0.05）。治疗24周后，阿卡波糖组的平均每日胰岛素剂量为16.4±10.1 IU，安慰剂组为22.4±12.2 IU（平均值±标准差；p < 0.07）。阿卡波糖治疗组餐后血糖、胰岛素和C肽的升高始终低于安慰剂组。例如，治疗24周结束时，阿卡波糖组餐后2小时血清胰岛素的平均升高几乎未变，而安慰剂组在研究期结束时升高至43±29 μU/ml（平均值±标准差）。
本研究结果表明，在磺脲类药物/胰岛素联合治疗中加用阿卡波糖可改善2型糖尿病患者的血糖控制。阿卡波糖还可能降低胰岛素抵抗和高胰岛素血症。
