Endocrinology
| T2D
Endocrinology
T2D

Efficacy and Safety of Higher Dulaglutide Doses (3.0 MG and 4.5 MG) When Added to Metformin in Patients With Type 2 Diabetes: A Phase 3, Randomized, Double-Blind, Parallel ARM Study (Award-11)

book_2 Source: ENDO Online 2020 - Poster session
calendar_today Published on Medfyle: July 2020
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Key messages

  • AWARD-11 is a 52-week, double-blind, randomized, controlled trial, assessing higher, investigational doses of dulaglutide (3.0 mg and 4.5 mg once weekly) compared with the currently available 1.5 mg once-weekly dose.
  • The primary efficacy endpoint of change in HbA1c at Week 36 was superior with the 3.0 mg and 4.5 mg dulaglutide doses compared with the 1.5-mg dose (1.5 mg, -1.5%; 3.0 mg, -1.7%; 4.5 mg, -1.9%; p=0.003 for 3.0 mg vs 1.5 mg and p<0.001 for 4.5 mg vs. 1.5 mg).
  • Change in body weight at Week 36 was also greater with the higher, investigational doses compared with the 1.5-mg dose (1.5 mg, -3.1 kg; 3.0 mg, -4.0 kg; 4.5 mg, -4.7 kg; p=0.001 for 3.0 mg vs 1.5 mg and p<0.001 for 4.5 mg vs. 1.5 mg).
  • Higher doses of dulaglutide were well-tolerated, with a safety profile comparable to the 1.5 mg dose, and that of other GLP-1 receptor agonists.
  • Escalation to higher dulaglutide doses should allow more patients to achieve and maintain treatment goals while remaining on the same therapy.
Presenting Author
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Juan Pablo Frias, MD
Medical Director and Principal Investigator
National Research Institute, Los Angeles, CA

 

Dr. Juan Pablo Frias is the Medical Director and Principal Investigator of the National Research Institute in Los Angeles, CA.  He received his medical degree from Vanderbilt University School of Medicine and completed his Fellowship in Endocrinology, Diabetes and Metabolism at the University of California, San Diego. He has been involved in diabetes and metabolism-related research for over 25 years and has authored numerous publications in this field.

Author disclosures
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Research Support: Allergan, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Janssen, Madrigal, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi, Theracos

Advisory Boards and Consulting: Acxella Health, Boehringer Ingelheim, Coherus Therapeutics, Eli Lilly, Gilead, Merck, Novo Nordisk, Sanofi

Speaker Bureau: Merck, Sanofi


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