Eliaschewitz Freddy G, Calvo Cesar, Valbuena Humberto, Ruiz Maximino, Aschner Pablo, Villena Jaime, Ramirez Luis A, Jimenez Jorge
Hospital Heliópolis, São Paulo, Brazil.
Arch Med Res. 2006 May;37(4):495-501. doi: 10.1016/j.arcmed.2005.10.015.
Type 2 diabetes (T2DM) patients often fail to achieve adequate glycemic control with oral antidiabetic drugs (OADs). Insulin has been shown to improve glycemic control in these patients but with increased risk of hypoglycemia. This study compared the efficacy and safety of insulin glargine and NPH insulin, both in combination with a once-daily fixed dose of glimepiride, in terms of glycemic control and incidence of hypoglycemia.
In this open-label, 24-week randomized trial in ten Latin American countries, T2DM patients poorly controlled on OADs (HbA1c > or = 7.5 and < or = 10.5%) received glimepiride plus insulin glargine (n = 231) or NPH insulin (n = 250) using a forced titration algorithm. The primary endpoint was the equivalence of 24-week mean changes in HbA1c.
Insulin glargine and NPH insulin achieved similar HbA1c reductions (adjusted mean difference -0.047; 90% CI -0.232, 0.138; per-protocol analysis). Confirmed nocturnal hypoglycemia was significantly lower with insulin glargine vs. NPH insulin (16.9 vs. 30.0%; p <0.01; safety analysis). Patients receiving insulin glargine were significantly more likely to achieve HbA1c levels < 7.0% without hypoglycemia (27 vs. 17%; p = 0.014; per-protocol analysis). There was a more pronounced treatment satisfaction improvement with insulin glargine vs. NPH insulin (p <0.02; full analysis). The proportion of patients who lost time from work or normal activities due to diabetes was lower with insulin glargine vs. NPH (1.8 vs. 3.3%; full analysis).
In patients with T2DM, inadequately controlled on OADs, once-daily insulin glargine plus glimepiride is effective in improving metabolic control with a reduced incidence of nocturnal hypoglycemia compared with NPH insulin.
2型糖尿病（T2DM）患者常难以通过口服降糖药（OADs）实现充分的血糖控制。胰岛素已被证明可改善这些患者的血糖控制，但低血糖风险增加。本研究比较了甘精胰岛素和中性鱼精蛋白锌胰岛素（NPH胰岛素）联合每日一次固定剂量格列美脲在血糖控制和低血糖发生率方面的疗效和安全性。
在这项在十个拉丁美洲国家进行的开放标签、为期24周的随机试验中，OADs治疗效果不佳（糖化血红蛋白[HbA1c]≥7.5%且≤10.5%）的T2DM患者使用强制滴定算法接受格列美脲加甘精胰岛素（n = 231）或NPH胰岛素（n = 250）治疗。主要终点是24周HbA1c平均变化的等效性。
甘精胰岛素和NPH胰岛素降低HbA1c的效果相似（校正平均差值为-0.047；90%置信区间为-0.232, 0.138；符合方案分析）。与NPH胰岛素相比，甘精胰岛素确诊的夜间低血糖显著更低（16.9%对30.0%；p<0.01；安全性分析）。接受甘精胰岛素治疗的患者在无低血糖情况下达到HbA1c水平<7.0%的可能性显著更高（27%对17%；p = 0.014；符合方案分析）。与NPH胰岛素相比，甘精胰岛素在治疗满意度改善方面更为显著（p<0.02；全面分析）。因糖尿病导致工作或正常活动时间损失的患者比例，甘精胰岛素组低于NPH胰岛素组（1.8%对3.3%；全面分析）。
在OADs治疗控制不佳的T2DM患者中，每日一次甘精胰岛素加格列美脲在改善代谢控制方面有效，且与NPH胰岛素相比夜间低血糖发生率降低。
