Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Lu, Guangzhou 510630, China.
Respiratory Department, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou 510000, China.
J Diabetes Res. 2018 Oct 21;2018:2791584. doi: 10.1155/2018/2791584. eCollection 2018.
Basal insulin plus oral hypoglycemic agents (OHAs) has not been investigated for early intensive antihyperglycemic treatment in people with newly diagnosed type 2 diabetes. This study is aimed at comparing the short-term (over a period of 12 days) effects of basal insulin glargine plus OHAs and continuous subcutaneous insulin infusion (CSII) on glycemic control and beta-cell function in this setting.
An open-label parallel-group study. Newly diagnosed hospitalized patients with type 2 diabetes and fasting plasma glucose (FPG) ≥11.1 mmol/L or glycated hemoglobin (HbA1c) ≥9% (75 mmol/mol) were randomized to CSII or insulin glargine in combination with metformin and gliclazide. The primary outcome measure was the mean amplitude of glycemic excursions (MAGE), and secondary endpoints included time to reach glycemic control target (FPG < 7 mmol/L and 2-hour postprandial plasma glucose < 10 mmol/L), markers of -cell function, and hypoglycemia.
Subjects in the CSII ( = 35) and basal insulin plus OHA ( = 33) groups had a similar significant reduction from baseline to end of treatment in glycated albumin (-6.44 ± 3.23% and- 6.42 ± 3.56%, = 0.970). Groups A and B have comparable time to glycemic control (3.6 ± 1.2 days and 4.0 ± 1.4 days), MAGE (3.40 ± 1.40 mmol/L vs. 3.16 ± 1.38 mmol/L; = 0.484), and 24-hour mean blood glucose (7.49 ± 0.96 mmol/L vs. 7.02 ± 1.03 mmol/L). Changes in the C-peptide reactivity index, the secretory unit of islet in transplantation index, and insulin secretion-sensitivity index-2 indicated a greater -cell function improvement with basal insulin plus OHAs versus CSII.
Short-term insulin glargine plus OHAs may be an alternative to CSII for initial intensive therapy in people with newly diagnosed type 2 diabetes.
尚未研究新诊断的 2 型糖尿病患者中基础胰岛素联合口服降糖药（OHA）的早期强化降糖治疗。本研究旨在比较基础胰岛素甘精胰岛素联合 OHA 和持续皮下胰岛素输注（CSII）在这种情况下对血糖控制和胰岛β细胞功能的短期（12 天内）影响。
这是一项开放标签的平行组研究。新诊断的住院 2 型糖尿病患者，空腹血糖（FPG）≥11.1mmol/L 或糖化血红蛋白（HbA1c）≥9%（75mmol/mol），随机分为 CSII 或胰岛素甘精胰岛素联合二甲双胍和格列齐特。主要观察指标为血糖波动幅度的平均幅度（MAGE），次要终点包括达到血糖控制目标（FPG<7mmol/L 和餐后 2 小时血糖<10mmol/L）的时间、β细胞功能标志物和低血糖。
CSII 组（n=35）和基础胰岛素联合 OHA 组（n=33）患者的糖化白蛋白从基线到治疗结束均有显著降低（-6.44±3.23%和-6.42±3.56%，=0.970）。两组达到血糖控制的时间（3.6±1.2 天和 4.0±1.4 天）、MAGE（3.40±1.40mmol/L 与 3.16±1.38mmol/L；=0.484）和 24 小时平均血糖（7.49±0.96mmol/L 与 7.02±1.03mmol/L）相当。C 肽反应指数、胰岛移植单位分泌指数和胰岛素分泌敏感性指数-2 的变化表明，基础胰岛素联合 OHA 比 CSII 更能改善β细胞功能。
短期胰岛素甘精胰岛素联合 OHA 可能是新诊断的 2 型糖尿病患者初始强化治疗的 CSII 替代方案。
