Bonora Enzo, Frias Juan P, Tinahones Francisco J, Van Joanna, Malik Raleigh E, Yu Zhuoxin, Mody Reema, Bethel Angelyn, Kwan Anita Y M, Cox David A
Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Verona, Verona, Italy.
National Research Institute, Los Angeles, California, USA.
Diabetes Obes Metab. 2021 Oct;23(10):2242-2250. doi: 10.1111/dom.14465. Epub 2021 Jun 29.
To evaluate the impact of dulaglutide 3.0 and 4.5 mg versus 1.5 mg on body weight in patients with type 2 diabetes (T2D) based on exploratory analyses of the AWARD-11 trial.
Patients were randomized to once-weekly dulaglutide 1.5 (n = 612), 3.0 (n = 616) or 4.5 mg (n = 614) for 52 weeks. The primary objective was superiority of dulaglutide 3.0 and/or 4.5 mg over 1.5 mg in HbA1c reduction at 36 weeks. Secondary and exploratory assessments included weight reduction in the overall trial population and baseline body mass index (BMI) and HbA1c subgroups.
At baseline, patients had a mean age of 57.1 years, HbA1c 8.6% (70 mmol/mol), weight 95.7 kg and BMI 34.2 kg/m . At 36 weeks, dulaglutide 3.0 and 4.5 mg were superior to 1.5 mg for weight change from baseline (1.5 mg, -3.1 kg; 3.0 mg, -4.0 kg [P = .001]; 4.5 mg, -4.7 kg [P < .001]). Higher dulaglutide doses were associated with numerically greater weight reduction compared with 1.5 mg in each baseline BMI and HbA1c subgroup. Absolute weight reduction increased with increasing BMI category, but percentage weight loss was similar between subgroups. Weight reductions with dulaglutide were greater in patients with lower versus higher baseline HbA1c.
In patients with T2D, inadequately controlled by metformin, incremental weight loss was observed with dulaglutide 1.5, 3.0 and 4.5 mg doses regardless of baseline BMI or HbA1c. Although absolute weight loss was numerically greater in patients with higher baseline BMI, percentage of weight loss was similar between BMI subgroups.
基于AWARD - 11试验的探索性分析，评估度拉糖肽3.0毫克和4.5毫克与1.5毫克相比对2型糖尿病（T2D）患者体重的影响。
患者被随机分为每周一次皮下注射度拉糖肽1.5毫克（n = 612）、3.0毫克（n = 616）或4.5毫克（n = 614），疗程为52周。主要目标是评估在36周时，度拉糖肽3.0毫克和/或4.5毫克在降低糖化血红蛋白（HbA1c）方面是否优于1.5毫克。次要和探索性评估包括整个试验人群以及基线体重指数（BMI）和HbA1c亚组的体重减轻情况。
在基线时，患者的平均年龄为57.1岁，HbA1c为8.6%（70 mmol/mol），体重为95.7千克，BMI为34.2千克/平方米。在36周时，度拉糖肽3.0毫克和4.5毫克在体重较基线变化方面优于1.5毫克（1.5毫克组体重减轻3.1千克；3.0毫克组，体重减轻4.0千克[P = 0.001]；4.5毫克组，体重减轻4.7千克[P < 0.001]）。与1.5毫克相比，在每个基线BMI和HbA1c亚组中，度拉糖肽剂量越高，体重减轻的数值越大。绝对体重减轻随着BMI类别增加而增加，但各亚组的体重减轻百分比相似。基线HbA1c较低的患者与较高的患者相比，使用度拉糖肽后的体重减轻更多。
在二甲双胍控制不佳的T2D患者中，无论基线BMI或HbA1c如何，度拉糖肽1.5毫克、3.0毫克和4.5毫克剂量均能使体重逐渐减轻。尽管基线BMI较高的患者绝对体重减轻数值更大，但BMI亚组之间的体重减轻百分比相似。
