Scripps Whittier Diabetes Institute, San Diego, CA, USA.
Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
J Diabetes Sci Technol. 2024 May;18(3):653-659. doi: 10.1177/19322968221149041. Epub 2023 Jan 29.
Derived time in range (dTIR), calculated from self-monitored blood glucose (SMBG-dTIR) profiles, has demonstrated correlation with risk of cardiovascular and microvascular complications. This post hoc analysis of the DUAL V and DUAL VIII trials aimed to compare dTIR with an insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus insulin glargine 100 units/mL (glargine U100) in people with type 2 diabetes (T2D).
Nine-point SMBG profiles were taken more than 24 hours at baseline and end of trial (EOT: 26 weeks [DUAL V] and 104 weeks [DUAL VIII]) and used to derive the percentage of readings within target range (70-180 mg/dL). Estimated treatment differences (ETDs, IDegLira-glargine U100) were analyzed using analysis of covariance, with treatment as fixed effects and baseline response as a covariate.
ETDs for change from baseline to EOT in dTIR were significantly greater with IDegLira versus glargine U100 in DUAL V (4.18%, = .027) and DUAL VIII (5.17%, = .001). The proportions of people achieving ≥70% dTIR at EOT with IDegLira and glargine U100, respectively, were 62% and 60% in DUAL V ( = .7541), and 50% and 26% in DUAL VIII ( < .0001). The proportion achieving a ≥5% increase in dTIR from baseline to EOT with IDegLira and glargine U100 was 63% in both groups in DUAL V ( = .9043), and 44% and 25%, respectively, in DUAL VIII ( < .0001).
IDegLira was associated with significantly greater increases in dTIR versus basal insulin alone in people with T2D.
TRIAL ID(S): ClinicalTrials.gov, NCT01952145 (DUAL V); ClinicalTrials.gov, NCT02501161 (DUAL VIII).
源自自我监测血糖（SMBG-dTIR）谱的时间在范围内（dTIR），已证明与心血管和微血管并发症的风险相关。本研究对 DUAL V 和 DUAL VIII 试验进行了事后分析，旨在比较 dTIR 与德谷胰岛素/利拉鲁肽固定比例复方制剂（IDegLira）和甘精胰岛素 100 单位/毫升（glargine U100）在 2 型糖尿病（T2D）患者中的疗效。
基线和试验结束时（26 周[DUAL V]和 104 周[DUAL VIII]）采集了 9 点 SMBG 谱，用于计算目标范围内（70-180mg/dL）读数的百分比。采用协方差分析比较治疗差异（IDegLira-glargine U100），以治疗为固定效应，以基线反应为协变量。
在 DUAL V 中，IDegLira 与 glargine U100 相比，dTIR 从基线到 EOT 的变化的估计治疗差异（ETD）有显著差异（4.18%，.027）；在 DUAL VIII 中，IDegLira 与 glargine U100 相比，dTIR 从基线到 EOT 的变化的估计治疗差异（ETD）有显著差异（5.17%，.001）。在 DUAL V 中，分别使用 IDegLira 和 glargine U100 治疗，在 EOT 时达到≥70% dTIR 的患者比例分别为 62%和 60%（ =.7541）；在 DUAL VIII 中，分别为 50%和 26%（ <.0001）。在 DUAL V 中，分别使用 IDegLira 和 glargine U100 治疗，与基线相比，EOT 时 dTIR 增加≥5%的患者比例分别为 63%（ =.9043）和 44%和 25%（ <.0001）。
在 2 型糖尿病患者中，IDegLira 与单独使用基础胰岛素相比，dTIR 的增加有显著差异。
ClinicalTrials.gov，NCT01952145（DUAL V）；ClinicalTrials.gov，NCT02501161（DUAL VIII）。
