Milicevic Z, Hancu N, Car N, Ivanyi T, Schwarzenhofer M, Jermendy G
Lilly Area Medical Center Vienna, Kölblgasse 8-10, Vienna, Austria.
Exp Clin Endocrinol Diabetes. 2009 May;117(5):223-9. doi: 10.1055/s-0028-1128126. Epub 2009 Mar 19.
In an open-label, 24-week, parallel-group study, 135 patients inadequately controlled with oral antihyperglycemic medications (OAMs) were treated with maximally tolerated doses of metformin and glibenclamide for at least 8 weeks and then randomized to bedtime neutral protamine Hagedorn (NPH) insulin plus maximally tolerated dose of glibenclamide BID (glib/NPH group) or insulin lispro mix 50 (50% lispro, 50% insulin lispro protamine suspension [ILPS]) pre-breakfast and lispro mix 25 (25% lispro, 75% ILPS) pre-dinner (LM50/LM25 group) (both OAMs discontinued). The LM50/LM25 group had significantly lower 2-hour postprandial BG (both meals combined) compared with glib/NPH after 12 (11.70+/-3.40 mmol/L vs. 13.15+/-2.44 mmol/L, p=0.010) and 24 weeks (11.13+/-3.31 mmol/L vs. 14.46+/-2.93 mmol/L, p =0.0001). Both regimens significantly decreased HbA1c. The reduction was greater with LM50/LM25 (-1.31+/-2% vs. -0.5+/-1.6%; P=0.01). At endpoint, the overall hypoglycemia rate increased with LM50/LM25 and decreased with glib/NPH compared with baseline (0.22+/-0.9 vs. -0.08+/-0.72 episodes/patient/30 days; p =0.037). Treatment with LM50/LM25 compared with glib/NPH in patients with inadequate control on combined OAMs yielded better postprandial and overall glycemic control with a higher rate of hypoglycemia.
在一项开放标签、为期24周的平行组研究中，135名口服降糖药物（OAM）控制不佳的患者接受了最大耐受剂量的二甲双胍和格列本脲治疗至少8周，然后随机分为睡前中性鱼精蛋白锌胰岛素（NPH）加最大耐受剂量的格列本脲每日两次（格列本脲/NPH组）或早餐前胰岛素赖脯混合50（50%赖脯胰岛素，50%胰岛素赖脯鱼精蛋白混悬液[ILPS]）和晚餐前赖脯混合25（25%赖脯胰岛素，75%ILPS）（LM50/LM25组）（两种OAM均停用）。与格列本脲/NPH组相比，LM50/LM25组在12周（11.70±3.40 mmol/L对13.15±2.44 mmol/L，p=0.010）和24周（11.13±3.31 mmol/L对14.46±2.93 mmol/L，p =0.0001）时餐后2小时血糖（两餐合计）显著更低。两种治疗方案均显著降低糖化血红蛋白（HbA1c）。LM50/LM25组的降低幅度更大（-1.31±2%对-0.5±1.6%；P=0.01）。在研究终点，与基线相比，LM50/LM25组的总体低血糖发生率增加，格列本脲/NPH组降低（0.22±0.9对-0.08±0.72次发作/患者/30天；p =0.037）。在联合OAM控制不佳患者中，与格列本脲/NPH组相比，LM50/LM25组餐后和总体血糖控制更佳，但低血糖发生率更高。
