Aristotle University of Thessaloniki, Thessaloniki, Greece (A.M., P.P., T.K., A.K., E.A., K.K., E.B.).
University of Oxford, Oxford, United Kingdom (D.R.M.).
Ann Intern Med. 2018 Aug 7;169(3):165-174. doi: 10.7326/M18-0443. Epub 2018 Jul 10.
Basal insulin analogues aim for protracted glycemic control with minimal adverse effects.
To assess the comparative efficacy and safety of basal insulin analogues for adults with type 2 diabetes mellitus (T2DM).
Several databases from inception to April 2018 without language restrictions, ClinicalTrials.gov to April 2018, references of reviews, and meeting abstract books.
Randomized trials lasting at least 12 weeks that compared efficacy (change in hemoglobin A1c [HbA1c] level from baseline [primary outcome]; percentage of patients with HbA1c level <7% at end of study and change in body weight [secondary outcomes]) and safety (hypoglycemia) of basal insulin analogues.
Two authors independently extracted data and assessed risk of bias for each outcome. All authors evaluated overall confidence in the evidence.
Thirty-nine trials (26 195 patients) assessed 10 basal insulin analogues. Low- to very-low-quality evidence indicated that thrice-weekly degludec (Deg-3TW) was inferior to most other regimens for reducing HbA1c level, with mean differences ranging from 0.21% (vs. degludec, 100 U/mL [Deg-100]) to 0.32% (vs. glargine, 300 U/mL [Glar-300]). High- to moderate-quality evidence suggested that detemir had a favorable weight profile versus all comparators, and Glar-300 was associated with less weight gain than glargine, 100 U/mL (Glar-100); Deg-100; degludec, 200 U/mL (Deg-200); Deg-3TW; and LY2963016. Low- and very-low-quality evidence suggested that Deg-100, Deg-200, and Glar-300 were associated with lower incidence of nocturnal hypoglycemia than detemir, Glar-100, LY2963016, and neutral protamine lispro (NPL). Incidence of severe hypoglycemia did not differ among regimens, except NPL, which was associated with increased risk versus Deg-100, detemir, Glar-100, and Glar-300.
Results are based mostly on indirect comparisons. Confidence in summary estimates is low or very low due to individual-study limitations, imprecision, or inconsistency.
Low-quality evidence suggests that basal insulin analogues for T2DM do not substantially differ in their glucose-lowering effect. Low- and very-low-quality evidence suggests some regimens may be associated with lower risk for nocturnal hypoglycemia (Deg-100, Deg-200, and Glar-300) or less weight gain (detemir and Glar-300).
None. (PROSPERO: CRD42016037055).
基础胰岛素类似物旨在实现血糖的长期控制，同时尽量减少不良反应。
评估基础胰岛素类似物在 2 型糖尿病成人患者中的疗效和安全性。
从各数据库建立之初至 2018 年 4 月检索，未设语言限制，检索 ClinicalTrials.gov 至 2018 年 4 月，检索综述的参考文献和会议摘要集。
持续至少 12 周的随机试验，比较基础胰岛素类似物的疗效（从基线开始的糖化血红蛋白（HbA1c）水平变化[主要结局]；研究结束时 HbA1c 水平＜7%的患者比例和体重变化[次要结局]）和安全性（低血糖）。
两位作者独立提取数据，并对每个结局的偏倚风险进行评估。所有作者评估了对证据的整体信心。
39 项试验（26195 名患者）评估了 10 种基础胰岛素类似物。低质量至极低质量证据表明，每周 3 次的地特胰岛素（Deg-3TW）在降低 HbA1c 水平方面劣于大多数其他方案，平均差异范围为 0.21%（与地特胰岛素 100 U/mL[Deg-100]相比）至 0.32%（与甘精胰岛素 300 U/mL[Glar-300]相比）。高质量至中等质量证据表明，地特胰岛素与所有对照相比具有良好的体重特征，与甘精胰岛素 100 U/mL（Glar-100）、甘精胰岛素 300 U/mL（Glar-300）、德谷胰岛素 100 U/mL（Deg-100）、德谷胰岛素 200 U/mL（Deg-200）、德谷胰岛素 3TW 相比，甘精胰岛素 300 U/mL（Glar-300）导致体重增加更少。低质量至极低质量证据表明，与德谷胰岛素 100 U/mL、德谷胰岛素 200 U/mL、甘精胰岛素 300 U/mL 相比，地特胰岛素、甘精胰岛素 100 U/mL、LY2963016 和中性鱼精蛋白锌胰岛素（NPL）发生夜间低血糖的发生率较低。除 NPL 外，方案之间低血糖发生率无差异，NPL 与地特胰岛素 100 U/mL、德谷胰岛素、甘精胰岛素 100 U/mL 和甘精胰岛素 300 U/mL 相比，发生严重低血糖的风险增加。
结果主要基于间接比较。由于个体研究的局限性、不精确性或不一致性，对汇总估计值的信心较低或非常低。
低质量证据表明，2 型糖尿病的基础胰岛素类似物在降低血糖方面没有显著差异。低质量至极低质量证据表明，一些方案可能与夜间低血糖风险较低（地特胰岛素 100 U/mL、地特胰岛素 200 U/mL 和甘精胰岛素 300 U/mL）或体重增加较少（地特胰岛素和甘精胰岛素 300 U/mL）相关。
无。（PROSPERO：CRD42016037055）。
