Ji Linong, Liu Jie, Xu Zhi Jin, Wei Zhiqi, Zhang Ruya, Malkani Seema, Cater Nilo B, Frederich Robert
Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Global Clinical Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
Diabetes Ther. 2023 Feb;14(2):319-334. doi: 10.1007/s13300-022-01345-6. Epub 2023 Feb 3.
The efficacy and safety of ertugliflozin have not been well characterized in Asian populations with type 2 diabetes (T2D) and overweight or obesity as defined by the Chinese Diabetes Society [body mass index (BMI) ≥ 24 kg/m].
These post hoc analyses of pooled data from two randomized, double-blind, 26-week studies assessed the efficacy and safety of ertugliflozin (5 mg or 15 mg) compared with placebo in participants from Asia with T2D and baseline BMI ≥ 24 kg/m, with inadequate glycemic control on metformin. Longitudinal analyses were used to calculate least squares (LS) mean [95% confidence interval (CI)] change from baseline in glycemic indices and body weight. The proportions of participants achieving efficacy targets and experiencing adverse events (AEs) were assessed.
The 445 participants had a mean age of 55.5 years, T2D duration 6.6 years, glycated hemoglobin (HbA1c) 8.1%, and BMI 27.6 kg/m. At week 26, placebo-adjusted LS mean (95% CI) changes from baseline for ertugliflozin 5 mg and 15 mg, respectively, were - 0.78% (- 0.95% to - 0.61%) and - 0.80% (- 0.98% to - 0.63%) for HbA1c, and - 1.74 kg (- 2.29 kg to - 1.19 kg) and - 2.04 kg (- 2.60 kg to - 1.48 kg) for body weight. A greater proportion of participants receiving ertugliflozin 5 mg and 15 mg versus placebo, respectively, achieved HbA1c < 7.0% (42.1% and 46.3% vs. 13.9%), body weight reduction ≥ 5% (35.5% and 38.3% vs. 11.1%), and systolic blood pressure < 130 mmHg (42.4% and 34.5% vs. 21.7%). The proportion of participants with AEs was 52.6% (ertugliflozin 5 mg), 52.3% (ertugliflozin 15 mg), and 55.6% (placebo).
In participants from Asia with T2D inadequately controlled by metformin monotherapy, and BMI ≥24 kg/m, ertugliflozin (5 mg or 15 mg) resulted in greater glycemic and body weight reductions compared with placebo and was generally well tolerated.
Clinicaltrials.gov identifiers NCT02033889, NCT02630706.
对于中国糖尿病学会定义的超重或肥胖（体重指数[BMI]≥24kg/m²）的亚洲2型糖尿病（T2D）患者，恩格列净的疗效和安全性尚未得到充分描述。
这些对两项随机、双盲、为期26周研究的汇总数据进行的事后分析，评估了恩格列净（5mg或15mg）与安慰剂相比，在亚洲T2D且基线BMI≥24kg/m²、二甲双胍治疗血糖控制不佳的参与者中的疗效和安全性。采用纵向分析计算血糖指标和体重相对于基线的最小二乘（LS）均值[95%置信区间（CI）]变化。评估了达到疗效目标和发生不良事件（AE）的参与者比例。
445名参与者的平均年龄为55.5岁，T2D病程6.6年，糖化血红蛋白（HbA1c）为8.1%，BMI为27.6kg/m²。在第26周时，与安慰剂相比，恩格列净5mg和15mg相对于基线的安慰剂调整后LS均值（95%CI）变化，HbA1c分别为-0.78%（-0.95%至-0.61%）和-0.80%（-0.98%至-0.63%），体重分别为-1.74kg（-2.29kg至-1.19kg）和-2.04kg（-2.60kg至-1.48kg）。与安慰剂相比，接受恩格列净5mg和15mg的参与者中，分别有更高比例达到HbA1c＜7.0%（42.1%和46.3% vs. 13.9%）、体重减轻≥5%（35.5%和38.3% vs. 11.1%）以及收缩压＜130mmHg（42.4%和34.5% vs. 21.7%）。发生AE的参与者比例分别为52.6%（恩格列净5mg）、52.3%（恩格列净15mg）和55.6%（安慰剂）。
在亚洲接受二甲双胍单药治疗血糖控制不佳且BMI≥24kg/m²的T2D患者中，恩格列净（5mg或15mg）与安慰剂相比，能更大程度地降低血糖和体重，且总体耐受性良好。
Clinicaltrials.gov标识符NCT02033889、NCT02630706。
