Wang Weimin, Chang Xiangyun, Lehrskov Lars Lang, Li Ling, Nordentoft Mads, Quan Jinxing, Sha Yubo, Zhong Xing, Yang Caixian, Zhu Dalong
Department of Endocrinology and Metabolism, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Department of Endocrinology and Metabolism, First Affiliated Hospital, School of Medicine, Shihezi University, Shihezi, China.
Diabetes Ther. 2024 Mar;15(3):725-739. doi: 10.1007/s13300-024-01533-6. Epub 2024 Mar 5.
Insulin degludec (degludec), an ultra-long-acting basal insulin analogue, provides equivalent glycemic control to other basal insulin analogues, with lower risk of hypoglycemia and flexible dosing. Chinese TREsiba AudiT (CN-TREAT) investigated outcomes with degludec in people with type 2 diabetes (T2D) in routine clinical practice in China.
This was a retrospective chart review study in adults with T2D initiating or switching to degludec at 50 sites in China between January 2020 and July 2021. The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline to end of study (EOS; week 20). Secondary endpoints included change from baseline to EOS in fasting plasma glucose (FPG), self-measured plasma glucose (SMPG), daily insulin dose, and rate of hypoglycemia.
Data from 936 participants were included (499 insulin-naïve; 437 insulin-experienced). Mean (95% confidence interval [CI]) HbA1c change from baseline to EOS was - 1.48%-points (- 1.57; - 1.38; P < 0.0001) overall: - 1.95%-points (- 2.08; - 1.81; P < 0.0001) in insulin-naïve participants and - 0.95%-points (- 1.08; - 0.82; P < 0.0001) in insulin-experienced participants. Mean (95% CI) changes in FPG and SMPG were - 2.27 mmol/L (- 2.69; - 1.85; P < 0.0001) and - 2.89 mmol/L (- 3.52; - 2.25; P < 0.0001), respectively, with similar reductions in insulin-naïve and insulin-experienced subgroups. Rate of hypoglycemia did not change statistically significantly from baseline to EOS overall, or in insulin-experienced participants, except when adjusted for baseline hypoglycemia. Basal insulin dose did not change statistically significantly in insulin-experienced participants.
In routine clinical practice in China, initiation or switching to degludec was associated with improvements in glycemic control in people with T2D, with no increased risk of hypoglycemia.
ClinialTrials.gov, NCT04227431.
德谷胰岛素（degludec）是一种超长效基础胰岛素类似物，与其他基础胰岛素类似物相比，能提供等效的血糖控制，低血糖风险更低且给药灵活。中国德谷胰岛素临床应用观察研究（CN-TREAT）在中国常规临床实践中对2型糖尿病（T2D）患者使用德谷胰岛素的疗效进行了调查。
这是一项回顾性病历审查研究，纳入了2020年1月至2021年7月期间在中国50个地点开始使用或换用德谷胰岛素的成年T2D患者。主要终点是糖化血红蛋白（HbA1c）从基线至研究结束（EOS；第20周）的变化。次要终点包括空腹血糖（FPG）、自我测量血糖（SMPG）、每日胰岛素剂量从基线至EOS的变化以及低血糖发生率。
纳入了936名参与者的数据（499名既往未使用胰岛素者；437名既往使用过胰岛素者）。总体而言，从基线至EOS，HbA1c的平均（95%置信区间[CI]）变化为-1.48个百分点（-1.57；-1.38；P<0.0001）：既往未使用胰岛素的参与者中为-1.95个百分点（-2.08；-1.81；P<0.0001），既往使用过胰岛素的参与者中为-0.95个百分点（-1.08；-0.82；P<0.0001）。FPG和SMPG的平均（95%CI）变化分别为-2.27 mmol/L（-2.69；-1.85；P<0.0001）和-2.89 mmol/L（-3.52；-2.25；P<0.0001），既往未使用胰岛素和既往使用过胰岛素的亚组中降低幅度相似。总体而言，从基线至EOS，低血糖发生率在统计学上无显著变化，在既往使用过胰岛素的参与者中也是如此，除非对基线低血糖情况进行调整。既往使用过胰岛素的参与者中，基础胰岛素剂量在统计学上无显著变化。
在中国的常规临床实践中，开始使用或换用德谷胰岛素与T2D患者血糖控制改善相关，且低血糖风险未增加。
ClinicalTrials.gov，NCT04227431。
