Publication:
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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Date

2021-10

Authors

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

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Wiley-Blackwell Publishing Ltd.
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Abstract

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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MeSH Terms

Diabetes Mellitus, Type 2
Glucagon-Like Peptides
Glycated Hemoglobin
Humans
Hypoglycemic Agents
Immunoglobulin Fc Fragments
Middle Aged
Recombinant Fusion Proteins

DeCS Terms

Pérdida de peso
Distinciones y premios
Peso corporal
Índice de masa corporal
Población
Metformina
Diabetes mellitus tipo 2
Pacientes

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Keywords

dulaglutide, type 2 diabetes, weight

Citation

Bonora E, Frias JP, Tinahones FJ, Van J, Malik RE, Yu Z, et al. Effect of dulaglutide 3.0 and 4.5 mg on weight in patients with type 2 diabetes: Exploratory analyses of AWARD-11. Diabetes Obes Metab. 2021 Oct;23(10):2242-2250.