Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes
Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes
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DOI：
10.2337/diacare.28.2.254
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发表时间：
2005-02-01
期刊：
影响因子：
16.2
通讯作者：
Yki-Jarvinen, H
中科院分区：
文献类型：
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作者：
Janka, HU;Kliebe-Frisch, C;Yki-Jarvinen, H
目的 - 比较口服降糖药 (OAD) 控制不佳的 2 型糖尿病患者中添加每日一次基础胰岛素与改用每日两次预混胰岛素的疗效和安全性。 研究设计和方法 - 在一项为期 24 周、多国、多中心、开放、平行组临床试验中，对 371 名未使用过胰岛素且血糖控制不佳（空腹血糖 [FBG] 大于或等于 120）的患者进行了研究mg/dI，HbA(1c) 7.5-10.5%)，接受 OAD（磺酰脲类加伊奈福明），随机接受每日一次早晨甘精胰岛素加格列美脲和二甲双胍（甘精胰岛素加 OAD）或每天两次 30% 雷拉/70% 人 NPH 胰岛素 (70/30)，不接受 OAD。使用每周强制滴定算法将胰岛素剂量滴定至目标 FBG 小于或等于 100 mg/dl（两种胰岛素），餐前血糖小于或等于 100 mg/dl（仅限 70/30）。 结果 - 前基线平均 HbA(1c) 下降明显更加明显（-1.64 与 -1.31%，P = 0.0003），更多患者达到甘精胰岛素联合 OAD 组的 HbA(1c) 低于或等于 7.0%，且无确认的夜间低血糖（45.5 vs. 28.6%，P = 0.0013），与 70/30 组相比。同样，甘精胰岛素加 OAD 组的 FBG 下降幅度更大（ad -17 mg/dl [-0.9 mmol/l]，o P < 0.0001），与 70/30 组相比，更多患者在甘精胰岛素加 OAD 时达到目标 FBG 小于或等于 1.00 mg/dl（31.6 vs. 15.0%，P = 0.0001）。甘精胰岛素加 OAD 患者的确诊低血糖发作次数少于 70/30 患者（平均 4.07 比 9.87/患者年，P < 0.0001）。 结论 - 在格列美脲加二甲双胍治疗中每日一次添加基础甘精胰岛素开始胰岛素治疗比开始每天两次注射 70/30 并停止 OAD 更安全、更有效2 名糖尿病患者使用 OAD 控制效果不佳。
OBJECTIVE - To compare the efficacy and safety of adding once-daily basal insulin versus switching to twice-daily premixed insulin in type 2 diabetic patients insufficiently controlled by oral antidiabetic agents (OADs).RESEARCH DESIGN AND METHODS - in a 24-week, multinational, multicenter, open, parallel group clinical trial, 371 insulin-naive patients With poor glycemic control (fasting blood glucose [FBG] greater than or equal to120 mg/dI, HbA(1c) 7.5-10.5%) on OADs (sulfonylurea plus inetformin) were randomized to once-daily morning insulin glargine plus glimepiride and metformin (glargine plus OAD) or to 30% reaular/70% human NPH insulin (70/30) twice daily without OADs. Insulin dosage Was titrated to target FBG less than or equal to 100 mg/dl (both insulins) and predinner blood glucose less than or equal to100 mg/dl (70/30 only) using a weekly forced-titration algorithm.RESULTS - Mean HbA(1c) decrease front baseline was significantly more pronounced (-1.64 vs. -1.31%, P = 0.0003), and more patients reached HbA(1c) less than or equal to 7.0% without confirmed nocturnal hypoglycemia (45.5 vs. 28.6%, P = 0.0013) with glargine plus OAD than with 70/30. Similarly, FBG decrease was greater with glargine plus OAD (ad -17 mg/dl [-0.9 mmol/l], o P < 0.0001), and more patients reached target FBG less than or equal to 1.00 mg/dl with glargine plus OAD than with 70/30 (31.6 vs. 15.0%, P = 0.0001). Glargine plus OAD patients had fewer confirmed hypoglycemic episodes than 70/30 patients (mean 4.07 vs. 9.87/patient-year, P < 0.0001).CONCLUSIONS - Initiating insulin treatment by adding basal insulin glargine once daily to glimepiride plus metformin treatment was safer and more effective than beginning twice-daily injections of 70/30 and discontinuing OADs in type 2 diabetic patients inadequately controlled with OADs.