Division of Endocrinology and Metabolism, Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Korea.
Department of Endocrinology and Metabolism, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.
Endocrinol Metab (Seoul). 2020 Mar;35(1):142-148. doi: 10.3803/EnM.2020.35.1.142.
This study was conducted to compare glycaemic control with insulin detemir administered according to two titration algorithms (3-0-3 and 2-4-6-8) after 20 weeks of treatment in subjects with type 2 diabetes mellitus inadequately controlled on metformin.
This was a 20-week, randomised, multicentre, open-labelled, treat-to-target trial. Forty-six patients were randomised in a 1:1 manner to either the 3-0-3 (G3, =23) or 2-4-6-8 (G2, =23) algorithm. The primary endpoint was change of haemoglobin A1c (HbA1c), and the secondary safety endpoint included hypoglycaemic events.
After 20 weeks, HbA1c decreased similarly in the G3 and G2 groups, with a mean change of -0.9% from baseline. The mean change in fasting plasma glucose was numerically similar in both groups. The hypoglycaemia event rate per 100-patient-years of exposure () in the G2 group (=1,427) was higher than that in the G3 group (=807).
Both treatment groups had numerically similar HbA1c reductions. A trend towards fewer hypoglycaemia episodes after dose stabilisation was seen with the simpler G3. Clinically, this may be an important observation, as a simpler titration algorithm may support self-management and maintenance of insulin therapy.
本研究旨在比较两种滴定算法（3-0-3 和 2-4-6-8）下，经过 20 周治疗后，二甲双胍控制不佳的 2 型糖尿病患者使用地特胰岛素的血糖控制情况。
这是一项为期 20 周、随机、多中心、开放性、以目标为导向的试验。46 名患者按 1:1 的比例随机分为 3-0-3 组（G3，n=23）或 2-4-6-8 组（G2，n=23）。主要终点为血红蛋白 A1c（HbA1c）的变化，次要安全性终点包括低血糖事件。
20 周后，G3 和 G2 组的 HbA1c 均有相似程度的降低，与基线相比平均变化分别为-0.9%。两组空腹血浆葡萄糖的平均变化也相似。G2 组（n=1,427）的低血糖事件发生率（每 100 患者-年）高于 G3 组（n=807）。
两组治疗组的 HbA1c 降低均具有数值相似性。在剂量稳定后，G3 组低血糖发作次数呈减少趋势。从临床角度来看，这可能是一个重要的观察结果，因为更简单的滴定算法可能有助于自我管理和维持胰岛素治疗。
