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Effect of dulaglutide 3.0 and 4.5 mg on weight in patients with type 2 diabetes: Exploratory analyses of AWARD-11.
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.
Afiliación
  • Bonora E; Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Verona, Verona, Italy.
  • Frias JP; National Research Institute, Los Angeles, California, USA.
  • Tinahones FJ; Hospital Universitario Virgen de la Victoria (IBIMA), Málaga and CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Málaga, Spain.
  • Van J; Diabetes Research Center, Tustin, California, USA.
  • Malik RE; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Yu Z; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Mody R; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Bethel A; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Kwan AYM; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Cox DA; Eli Lilly and Company, Indianapolis, Indiana, USA.
Diabetes Obes Metab ; 23(10): 2242-2250, 2021 10.
Article en En | MEDLINE | ID: mdl-34189841
AIM: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Clinical_trials Límite: Humans / Middle aged Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2021 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Clinical_trials Límite: Humans / Middle aged Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2021 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido