Division of Endocrinology and Metabolic Diseases and Department of Medicine and Surgery, University of Parma and AOU of Parma Italy, Parma, Italy.
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Università Cattolica del Sacro Cuore, Rome, Italy.
Diabetes Metab Res Rev. 2020 Sep;36(6):e3304. doi: 10.1002/dmrr.3304. Epub 2020 Apr 5.
People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM.
ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs), and adverse events.
Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA reduction from baseline was non-inferior in patient- vs physician-managed arms [least squares mean (LSM) change (SE): -1.60% (0.06) vs -1.49% (0.06), respectively; LSM difference: -0.11% (95% CI: -0.26 to 0.04)]. The incidence and rates of hypoglycaemia were similarly low in both arms: relative risk of confirmed and/or severe nocturnal (00:00-05:59 hours) hypoglycaemia was 0.77 (95% CI: 0.27 to 2.18). No differences were observed for improvement in PROs. No safety concerns were reported.
In the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.
未使用基础胰岛素治疗的 2 型糖尿病（T2DM）患者常延迟起始和调整基础胰岛素剂量。患者自我管理的剂量调整可能会减少这种延迟。意大利剂量调整方法研究（ITAS）比较了在未使用过胰岛素的 T2DM 患者中，使用患者自我管理（护士支持）或医生管理起始和调整甘精胰岛素 300U/mL（Gla-300）的疗效和安全性。
ITAS 是一项多中心、四期、24 周、开放标签、随机（1:1）、平行组研究。在停用 SU/格列奈类药物后，起始 Gla-300 治疗，且 T2DM 病史≥1 年、代谢控制不佳的胰岛素初治成人患者被纳入研究，并随机分为自我调整胰岛素剂量（护士协助）或由医生调整剂量。主要终点为 HbA 变化。次要结局包括低血糖发生率和发生率、空腹自我监测血糖变化、患者报告结局（PROs）和不良事件。
355 例患者被纳入意向治疗人群。在第 24 周时，与医生管理组相比，患者自我管理组的 HbA 自基线的降低不劣效[最小二乘均数（LSM）变化（SE）：-1.60%（0.06）vs -1.49%（0.06），LSM 差值：-0.11%（95%CI：-0.26 至 0.04）]。两组低血糖的发生率和发生率相似：夜间（00:00 至 05:59 小时）确认和/或严重低血糖的相对风险为 0.77（95%CI：0.27 至 2.18）。PROs 的改善无差异。未报告安全性问题。
在胰岛素初治、停用 SU/格列奈类药物的 T2DM 患者中，患者自我管理（护士协助）的 Gla-300 剂量调整可能是一种合适的选择，因为它可提供改善的血糖控制，且低血糖风险低，与医生管理的剂量调整相似。
