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Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).

Authors
  • Frias, Juan P1
  • Bonora, Enzo2
  • Nevarez Ruiz, Luis3
  • Li, Ying G4
  • Yu, Zhuoxin4
  • Milicevic, Zvonko4
  • Malik, Raleigh4
  • Bethel, M Angelyn4
  • Cox, David A5
  • 1 National Research Institute, Los Angeles, CA.
  • 2 Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Verona, Verona, Italy. , (Italy)
  • 3 Hospital Angeles Chihuahua, Chihuahua, Mexico. , (Mexico)
  • 4 Eli Lilly and Company, Indianapolis, IN. , (India)
  • 5 Eli Lilly and Company, Indianapolis, IN [email protected] , (India)
Type
Published Article
Journal
Diabetes care
Publication Date
Jan 04, 2021
Identifiers
DOI: 10.2337/dc20-1473
PMID: 33397768
Source
Medline
Language
English
License
Unknown

Abstract

To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks. The primary objective was determining superiority of dulaglutide 3.0 mg and/or 4.5 mg over 1.5 mg in HbA1c reduction at 36 weeks. Secondary superiority objectives included change in body weight. Two estimands addressed efficacy objectives: treatment regimen (regardless of treatment discontinuation or rescue medication) and efficacy (on treatment without rescue medication) in all randomly assigned patients. Mean baseline HbA1c and BMI in randomly assigned patients (N = 1,842) was 8.6% (70 mmol/mol) and 34.2 kg/m2, respectively. At 36 weeks, dulaglutide 4.5 mg provided superior HbA1c reductions compared with 1.5 mg (treatment-regimen estimand: -1.77 vs. -1.54% [-19.4 vs. -16.8 mmol/mol], estimated treatment difference [ETD] -0.24% (-2.6 mmol/mol), P < 0.001; efficacy estimand: -1.87 vs. -1.53% [-20.4 vs. -16.7 mmol/mol], ETD -0.34% (-3.7 mmol/mol), P < 0.001). Dulaglutide 3.0 mg was superior to 1.5 mg for reducing HbA1c, using the efficacy estimand (ETD, -0.17% [-1.9 mmol/mol]; P = 0.003) but not the treatment-regimen estimand (ETD, -0.10% [-1.1 mmol/mol ]; P = 0.096). Dulaglutide 4.5 mg was superior to 1.5 mg for weight loss at 36 weeks for both estimands (treatment regimen: -4.6 vs. -3.0 kg, ETD, -1.6 kg, P < 0.001; efficacy: -4.7 vs. -3.1 kg, ETD, -1.6 kg, P < 0.001). Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%). In patients with type 2 diabetes inadequately controlled by metformin, escalation from dulaglutide 1.5 mg to 3.0 mg or 4.5 mg provided clinically relevant, dose-related reductions in HbA1c and body weight with a similar safety profile. © 2021 by the American Diabetes Association.

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