Endocr Pract. 2018 Feb;24(2):143-149. doi: 10.4158/EP171922.OR. Epub 2017 Nov 6.
Assess efficacy, hypoglycemia, and weight gain in patients with type 2 diabetes (T2D) treated with insulin glargine 300 U/mL (Gla-300) or 100 U/mL (Gla-100) across different age groups.
Pooled data were generated for patients randomized to Gla-300 or Gla-100 in the EDITION 2 (NCT01499095) and 3 (NCT01676220) studies. In 4 age groups (<55, ≥55 to <60, ≥60 to <65, ≥65 years), glycated hemoglobin A1C (A1C), percentage of patients reaching A1C <7.5% (58 mmol/mol), weight change, confirmed hypoglycemia (blood glucose ≤70 mg/dL), and/or severe hypoglycemia (events requiring third-party assistance) were analyzed with descriptive statistics and logistic, binomial, and analysis of covariance regression modeling.
A1C reductions from baseline and proportions of patients at target were similar for Gla-300 and Gla-100 across all age groups at 6 and 12 months, but hypoglycemia incidence and event rate were lower with Gla-300 at 6 (both P<.001) and 12 months ( P<.001 and P = .005, respectively). Patients on Gla-300 gained less weight than those on Gla-100 at 6 ( P = .027) and 12 months ( P = .021). Changes in weight and daily weight-adjusted insulin dose decreased with increasing age at 6 ( P<.001 and P = .017, respectively) and 12 months ( P<.001 and P = .011, respectively).
Older patients with T2D may benefit from treatment with Gla-300, which is associated with a lower hypoglycemia rate and less weight gain with similar efficacy compared with Gla-100.
A1C = glycated hemoglobin A1C BMI = body mass index Gla-100 = insulin glargine 100 U/mL Gla-300 = insulin glargine 300 U/mL OAD = oral antidiabetes drug T2D = type 2 diabetes.
评估在不同年龄组的 2 型糖尿病(T2D)患者中使用甘精胰岛素 300 U/mL(Gla-300)或 100 U/mL(Gla-100)治疗的疗效、低血糖和体重增加。
对 EDITION 2(NCT01499095)和 3(NCT01676220)研究中随机分配至 Gla-300 或 Gla-100 的患者进行汇总数据分析。在 4 个年龄组(<55 岁、≥55 岁至<60 岁、≥60 岁至<65 岁、≥65 岁)中,分析糖化血红蛋白 A1C(A1C)、达到 A1C<7.5%(58 mmol/mol)的患者比例、体重变化、确诊低血糖(血糖≤70mg/dL)和/或严重低血糖(需要第三方协助的事件),并采用描述性统计和逻辑、二项和协方差回归模型进行分析。
在 6 个月和 12 个月时,Gla-300 和 Gla-100 在所有年龄组的 A1C 降低和达到目标的患者比例相似,但 6 个月时(均 P<.001)和 12 个月时(P<.001 和 P =.005)低血糖的发生率和事件率更低。与 Gla-100 相比,Gla-300 治疗的患者在 6 个月(P=.027)和 12 个月(P=.021)时体重增加较少。体重和每日体重调整胰岛素剂量的变化随着 6 个月时年龄的增加而降低(P<.001 和 P =.017,分别)和 12 个月时(P<.001 和 P =.011,分别)。
与 Gla-100 相比,老年 T2D 患者使用 Gla-300 治疗可能获益更多,因为它低血糖发生率更低,体重增加更少,疗效相似。
A1C = 糖化血红蛋白 A1C BMI = 体重指数 Gla-100 = 甘精胰岛素 100 U/mL Gla-300 = 甘精胰岛素 300 U/mL OAD = 口服抗糖尿病药物 T2D = 2 型糖尿病。