Effect of dulaglutide 3.0 and 4.5 mg on weight in patients with type 2 diabetes: Exploratory analyses of AWARD-11.

Effect of dulaglutide 3.0 and 4.5 mg on weight in patients with type 2 diabetes: Exploratory analyses of AWARD-11.
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DOI:
10.1111/dom.14465
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发表时间:
2021-10
期刊:
Diabetes, obesity & metabolism
影响因子:
--
通讯作者:
Cox DA
Cox DA
中科院分区:
其他
文献类型:
--
作者:
Bonora E;Frias JP;Tinahones FJ;Van J;Malik RE;Yu Z;Mody R;Bethel A;Kwan AYM;Cox DA

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基于AWARD‐11试验的探索性分析,评估3.0、4.5 mg杜拉鲁肽与1.5 mg杜拉鲁肽对2型糖尿病(T2D)患者体重的影响。患者被随机分配到每周一次的dulaglutide 1.5 (n = 612), 3.0 (n = 616)或4.5 mg (n = 614),持续52周。主要目的是36周时,3.0和/或4.5 mg杜拉鲁肽在降低HbA1c方面优于1.5 mg。次要和探索性评估包括总体试验人群的体重减轻、基线体重指数(BMI)和HbA1c亚组。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 kg, BMI为34.2 kg/m2。在36周时,dulaglutide 3.0和4.5 mg优于1.5 mg的基线体重变化(1.5 mg,−3.1 kg; 3.0 mg,−4.0 kg [P = 0.001]; 4.5 mg,−4.7 kg [P < 0.001])。与每个基线BMI和HbA1c亚组的1.5 mg相比,更高剂量的杜拉鲁肽与数值上更大的体重减轻相关。绝对体重下降随着BMI类别的增加而增加,但亚组之间的体重下降百分比相似。基线HbA1c较低的患者与基线HbA1c较高的患者相比,使用dulaglutide减轻体重的效果更大。在二甲双胍控制不充分的T2D患者中,无论基线BMI或HbA1c如何,使用dulaglutide 1.5、3.0和4.5 mg剂量均可观察到体重减轻。虽然在基线BMI较高的患者中,绝对体重减轻的数值更大,但体重减轻的百分比在BMI亚组之间是相似的。
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/m2. 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.
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