Department of Diabetology, Metabolism, and Endocrinology, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
Diabetol Metab Syndr. 2014 Feb 15;6(1):20. doi: 10.1186/1758-5996-6-20.
Add-on Lantus® to Oral Hypoglycemic Agents (ALOHA), an observational, non-interventional, 24-week post-marketing surveillance study in Japanese patients with type 2 diabetes (T2DM) having uncontrolled glycemic control, demonstrated that basal supported oral therapy (BOT) with insulin glargine was an effective and safe treatment in real-life clinical practice. We performed subgroup analysis to identify incidence and predictors associated with risk of hypoglycemia.
Among 4219 patients with T2DM, 3732 patients were insulin-naïve and 487 patients were insulin non-naïve who switched from other insulin to insulin glargine. All hypoglycemic episodes were counted by physicians' documentation based on patients' reports. Relationships between baseline patient characteristics and glargine-related hypoglycemic episodes were examined by univariate and multivariate analysis.
Among 4219 patients, 44 (1.0%) patients experienced hypoglycemic episodes (41 insulin-naïve patients; 3 insulin non-naïve patients), with a rate of incidence 0.035 episodes/patient-years. Majority of patients with hypoglycemia (37 of 44) had just one hypoglycemic episode during study period. Among insulin-naïve patients, incidence of hypoglycemia differed significantly depending on age, diabetic complications, estimated glomerular filtration rate (eGFR), and postprandial plasma glucose (P <0.05). In a multivariate adjusted model, poor renal function (eGFR <60 mL/min/1.73 m2) was a statistically significant risk factor (P < 0.05).
Our results suggest that BOT using insulin glargine is an option of insulin therapy with 1% risk of hypoglycemia in patients with T2DM with inadequate glycemic control. Patients with low renal function might need a careful follow-up.
在血糖控制不佳的日本 2 型糖尿病（T2DM）患者中开展的一项观察性、非干预性、为期 24 周的上市后监测研究——Add-on Lantus® to Oral Hypoglycemic Agents（ALOHA）表明，基础胰岛素联合口服降糖药治疗（BOT）方案中使用甘精胰岛素是一种有效且安全的治疗方法，适用于真实临床实践。我们进行了亚组分析，以确定低血糖风险相关的发生率和预测因素。
在 4219 例 T2DM 患者中，3732 例患者为胰岛素初治患者，487 例患者为胰岛素非初治患者，他们从其他胰岛素转换为甘精胰岛素。所有低血糖事件均由医生根据患者报告进行记录。通过单因素和多因素分析，研究了基线患者特征与甘精胰岛素相关低血糖事件之间的关系。
在 4219 例患者中，有 44 例（1.0%）患者发生低血糖事件（41 例为胰岛素初治患者，3 例为胰岛素非初治患者），发生率为 0.035 例/患者-年。研究期间大多数低血糖患者（44 例中的 37 例）仅发生 1 次低血糖事件。在胰岛素初治患者中，低血糖发生率因年龄、糖尿病并发症、估算肾小球滤过率（eGFR）和餐后血糖（P <0.05）而异。在多变量调整模型中，肾功能不佳（eGFR <60 mL/min/1.73 m2）是一个具有统计学意义的风险因素（P <0.05）。
我们的研究结果表明，对于血糖控制不佳的 T2DM 患者，采用甘精胰岛素的 BOT 治疗方案是胰岛素治疗的一种选择，低血糖风险为 1%。肾功能低下的患者可能需要密切随访。
