Davies Melanie, Storms Fred, Shutler Simon, Bianchi-Biscay Monique, Gomis Ramon
University Hospitals of Leicester, Leicester Royal Infirmary, Infirmary Close, Leicester LE1 5WW, U.K.
Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
Large prospective studies have demonstrated that optimum glycemic control is not routinely achieved in clinical practice. Barriers to optimal insulin therapy include hypoglycemia, weight gain, and suboptimal initiation and dose titration. This study compared two treatment algorithms for insulin glargine initiation and titration: algorithm 1 (investigator led) versus algorithm 2 (performed by study subjects).
A prospective, multicenter (n = 611), multinational (n = 59), open-label, 24-week randomized trial in 4,961 (algorithm 1, n = 2,493; algorithm 2, n = 2,468) suboptimally controlled type 2 diabetic subjects.
At baseline, mean diabetes duration was 12.3 +/- 7.2 years, and 72% of subjects were pretreated with insulin. At end point, there was no significant difference in the incidence of severe hypoglycemia between algorithms 1 and 2 (0.9 vs. 1.1%). There was a significant reduction in HbA(1c) from 8.9 +/- 1.3 to 7.8 +/- 1.2%, with a greater decrease (P < 0.001) with algorithm 2 (-1.22%) versus algorithm 1 (-1.08%). Fasting blood glucose decreased from 170 to 110 mg/dl, with a greater decrease (P < 0.001) with algorithm 2 (-62 mg/dl) versus algorithm 1 (-57 mg/dl). Mean basal insulin dose increased from 22.9 +/- 15.5 to 43.0 +/- 25.5 IU, with a significant difference (P < 0.003) between algorithm 2 (21.6 IU) and algorithm 1 (18.7 IU).
Glargine is safe and effective in improving glycemic control in a large, diverse population with longstanding type 2 diabetes. A simple subject-administered titration algorithm conferred significantly improved glycemic control with a low incidence of severe hypoglycemia compared with physician-managed titration.
大型前瞻性研究表明，临床实践中通常无法实现最佳血糖控制。最佳胰岛素治疗的障碍包括低血糖、体重增加以及起始治疗和剂量滴定欠佳。本研究比较了两种甘精胰岛素起始治疗和滴定算法：算法1（由研究者主导）与算法2（由研究对象执行）。
一项针对4961例（算法1组2493例；算法2组2468例）血糖控制欠佳的2型糖尿病患者的前瞻性、多中心（n = 611）、跨国（n = 59）、开放标签、为期24周的随机试验。
基线时，糖尿病平均病程为12.3±7.2年，72%的患者曾接受胰岛素治疗。在终点时，算法1和算法2之间严重低血糖的发生率无显著差异（0.9%对1.1%）。糖化血红蛋白（HbA1c）从8.9±1.3%显著降至7.8±1.2%，算法2（-1.22%）比算法1（-1.08%）降低幅度更大（P < 0.001）。空腹血糖从170 mg/dl降至110 mg/dl，算法2（-62 mg/dl）比算法1（-57 mg/dl）降低幅度更大（P < 0.001）。基础胰岛素平均剂量从22.9±15.5 IU增至43.0±25.5 IU，算法2（21.6 IU）与算法1（18.7 IU）之间存在显著差异（P < 0.003）。
甘精胰岛素在改善大量不同的长期2型糖尿病患者血糖控制方面安全有效。与医生管理的滴定相比，一种简单的由患者自行管理的滴定算法能显著改善血糖控制，且严重低血糖发生率较低。
