University of North Carolina School of Medicine, Chapel Hill, NC.
Endocrine and Metabolic Consultants, Rockville, MD.
Diabetes Care. 2016 Jan;39(1):92-100. doi: 10.2337/dc15-1531. Epub 2015 Nov 17.
To evaluate the efficacy and safety of basal insulin peglispro (BIL) versus insulin glargine in patients with type 2 diabetes (hemoglobin A1c [HbA1c] ≤9% [75 mmol/mol]) treated with basal insulin alone or with three or fewer oral antihyperglycemic medications.
This 52-week, open-label, treat-to-target study randomized patients (mean HbA1c 7.42% [57.6 mmol/mol]) to BIL (n = 307) or glargine (n = 159). The primary end point was change from baseline HbA1c to 26 weeks (0.4% [4.4 mmol/mol] noninferiority margin).
At 26 weeks, reduction in HbA1c was superior with BIL versus glargine (-0.82% [-8.9 mmol/mol] vs. -0.29% [-3.2 mmol/mol]; least squares mean difference -0.52%, 95% CI -0.67 to -0.38 [-5.7 mmol/mol, 95% CI -7.3 to -4.2; P < 0.001); greater reduction in HbA1c with BIL was maintained at 52 weeks. More BIL patients achieved HbA1c <7% (53 mmol/mol) at weeks 26 and 52 (P < 0.001). With BIL versus glargine, nocturnal hypoglycemia rate was 60% lower, more patients achieved HbA1c <7% (53 mmol/mol) without nocturnal hypoglycemia at 26 and 52 weeks (P < 0.001), and total hypoglycemia rates were lower at 52 weeks (P = 0.03). At weeks 26 and 52, glucose variability was lower (P < 0.01), basal insulin dose was higher (P < 0.001), and triglycerides and aminotransferases were higher with BIL versus glargine (P < 0.05). Liver fat content (LFC), assessed in a subset of patients (n = 162), increased from baseline with BIL versus glargine (P < 0.001), with stable levels between 26 and 52 weeks.
BIL provided superior glycemic control versus glargine, with reduced nocturnal and total hypoglycemia, lower glucose variability, and increased triglycerides, aminotransferases, and LFC.
评估培格列净基础胰岛素（BIL）与甘精胰岛素在单独使用基础胰岛素或联合使用三种或更少口服抗高血糖药物治疗的 2 型糖尿病（糖化血红蛋白 [HbA1c]≤9%[75mmol/mol]）患者中的疗效和安全性。
这是一项为期 52 周、开放标签、以目标为导向的研究，将患者（平均 HbA1c 7.42%[57.6mmol/mol]）随机分为 BIL（n=307）或甘精胰岛素组（n=159）。主要终点是从基线 HbA1c 到 26 周的变化（0.4%[4.4mmol/mol]非劣效性边界）。
在 26 周时，BIL 组较甘精胰岛素组降低 HbA1c 的效果更好（-0.82%[-8.9mmol/mol] vs.-0.29%[-3.2mmol/mol]；最小二乘均值差异-0.52%，95%CI-0.67 至-0.38[-5.7mmol/mol，95%CI-7.3 至-4.2；P<0.001）；BIL 组在 52 周时保持了更大的 HbA1c 降低。更多的 BIL 患者在 26 周和 52 周时达到 HbA1c<7%（53mmol/mol）（P<0.001）。与甘精胰岛素相比，BIL 夜间低血糖发生率降低 60%，更多患者在 26 周和 52 周时达到 HbA1c<7%（53mmol/mol）且无夜间低血糖（P<0.001），52 周时总低血糖发生率更低（P=0.03）。在 26 周和 52 周时，BIL 组血糖变异性更低（P<0.01），基础胰岛素剂量更高（P<0.001），BIL 组甘油三酯和氨基转移酶水平高于甘精胰岛素组（P<0.05）。在接受治疗的患者中（n=162），有一部分患者接受了肝脏脂肪含量（LFC）评估，与甘精胰岛素相比，BIL 组的 LFC 从基线开始增加（P<0.001），26 周至 52 周之间保持稳定。
与甘精胰岛素相比，BIL 提供了更好的血糖控制，夜间和总低血糖发生率更低，血糖变异性更低，甘油三酯、氨基转移酶和 LFC 升高。
