Diabeteszentrum am Marienplatz, Munich, Germany.
Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Diabetes Obes Metab. 2019 Jun;21(6):1340-1348. doi: 10.1111/dom.13658. Epub 2019 Mar 15.
Insulin-treated patients with type 2 diabetes (T2D) and obesity are challenged in achieving body weight stability or reduction, in addition to glycaemic control. Post-hoc analyses of body weight and insulin dose data from the AWARD-4 trial involved comparison of treatment with once-weekly dulaglutide 1.5 mg (N = 295) or 0.75 mg (N = 293) and treatment with daily insulin glargine (N = 296), each with prandial insulin lispro (± metformin).
Changes in weight and in the proportion of patients without weight gain or with weight loss of at least 3%, 5% or 10% or composites of HbA1c less than 7% without weight gain and weight loss of at least 3% after 52 weeks were compared between the dulaglutide (either dose) groups and the insulin glargine group, overall and by baseline BMI (<30, 30-<35, ≥35 kg/m ), using analysis of covariance and logistic regression, including interaction terms.
The following parameters were statistically significant (P < 0.01) in favour of the dulaglutide-treated groups, at lower mean total daily insulin doses, vs the insulin glargine group. The achieved targets were more pronounced with dulaglutide 1.5 mg than with insulin glargine: LSM weight change difference, -3.23 kg; proportion of patients without weight gain, 49.0% vs 19.0%; proportion of patients with weight loss ≥3%, 21.7% vs 5.7% or with weight loss ≥5%, 10.5% vs 2.4%; proportion of patients with HbA1c <7% without weight gain, 26.2% vs 7.9%; proportion of patients with HbA1c <7% and weight loss ≥3%, 11.9% vs 1.4%, respectively. Treatment effect for these parameters was not significantly different across BMI categories.
Larger proportions of patients in late-stage T2D needing treatment intensification achieved glycemic control without weight gain or with weight loss at lower insulin doses with once-weekly dulaglutide plus daily prandial insulin than with a basal-bolus insulin regimen, overall and across all three BMI subgroups.
接受胰岛素治疗的 2 型糖尿病（T2D）和肥胖患者在控制血糖的同时，还面临着体重稳定或减轻的挑战。AWARD-4 试验的体重和胰岛素剂量的事后分析比较了每周一次的度拉糖肽 1.5mg（N=295）或 0.75mg（N=293）与每日胰岛素甘精的治疗效果（N=296），同时联合餐时胰岛素赖脯（±二甲双胍）。
比较每周一次的度拉糖肽（任一度量）与每日胰岛素甘精的治疗效果，整体及按基线 BMI（<30、30-<35、≥35kg/m2）比较，52 周后体重变化和无体重增加或体重减轻至少 3%、5%或 10%或 HbA1c<7%且无体重增加和体重减轻至少 3%的患者比例，采用协方差分析和逻辑回归，包括交互项。
与胰岛素甘精组相比，度拉糖肽治疗组在较低的平均总日胰岛素剂量下，以下参数具有统计学意义（P<0.01），更有利于度拉糖肽治疗组：LSM 体重变化差异，-3.23kg；无体重增加的患者比例，49.0%比 19.0%；体重减轻≥3%的患者比例，21.7%比 5.7%或体重减轻≥5%的患者比例，10.5%比 2.4%；无体重增加的 HbA1c<7%的患者比例，26.2%比 7.9%；HbA1c<7%且体重减轻≥3%的患者比例，11.9%比 1.4%。这些参数的治疗效果在 BMI 类别之间没有显著差异。
在需要强化治疗的晚期 T2D 患者中，与基础-餐时胰岛素方案相比，每周一次的度拉糖肽联合每日餐时胰岛素，在较低的胰岛素剂量下，可使更大比例的患者实现血糖控制且不增加体重或减轻体重，整体及所有三个 BMI 亚组均如此。
