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Efficacy and Safety of Dulaglutide in the Treatment of Type 2 Diabetes: A Comprehensive Review of the Dulaglutide Clinical Data Focusing on the AWARD Phase 3 Clinical Trial Program
Örebro University, School of Medical Sciences.ORCID iD: 0000-0003-1025-1682
Grunberger Diabetes Institute, Bloomfield Hills, USA.
Texas Diabetes and Endocrinology, Austin, USA.
University Bari Aldo Moro, Bari, Italy.
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2016 (English)In: Diabetes/Metabolism Research Reviews, ISSN 1520-7552, E-ISSN 1520-7560, Vol. 32, no 8, p. 776-790Article, review/survey (Refereed) Published
Abstract [en]

Dulaglutide (DU) is a once weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for the treatment of type 2 diabetes mellitus (T2DM). Glycaemic efficacy and safety characteristics of DU have been assessed in six Phase 3 studies in the AWARD program. The objective of this review article is to summarise these results from the 6 completed AWARD studies. At the primary endpoint, in 5 of the 6 studies, once weekly dulaglutide 1.5 mg was superior to the active comparator (exenatide, insulin glargine [two studies], metformin, and sitagliptin), with a greater proportion of patients reaching glycated haemoglobin A1c (HbA1c) targets of <7.0% (53.0 mmol/mol) and ≤6.5% (47.5 mmol/mol). Dulaglutide 1.5 mg was non-inferior to liraglutide in AWARD-6. Once weekly dulaglutide 0.75 mg was evaluated in 5 of these trials and demonstrated superiority to the active comparator in 4 of 5 AWARD studies (exenatide, glargine, metformin, and sitagliptin), and non-inferiority to glargine in the AWARD-2 study. Similar to other GLP-1 RAs, treatment with dulaglutide was associated with weight loss or attenuation of weight gain and low rates of hypoglycaemia when used alone or with non-insulin-secretagogue therapy. The most frequently reported adverse events were gastrointestinal, including nausea, diarrhoea, and vomiting. The incidence of dulaglutide antidrug antibody formation was 1%-2.8% with rare injection site reactions. In conclusion, dulaglutide is an effective treatment for T2DM and has an acceptable tolerability and safety profile.

Place, publisher, year, edition, pages
Wiley-Blackwell, 2016. Vol. 32, no 8, p. 776-790
Keywords [en]
Dulaglutide, GLP-1 receptor agonist, type 2 diabetes
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:oru:diva-49943DOI: 10.1002/dmrr.2810ISI: 000386962100001PubMedID: 27102969Scopus ID: 2-s2.0-84969988486OAI: oai:DiVA.org:oru-49943DiVA, id: diva2:923324
Note

Funding Agency:

Eli Lilly and Company, Indianapolis, Indiana, USA

Available from: 2016-04-26 Created: 2016-04-26 Last updated: 2017-11-30Bibliographically approved

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Jendle, Johan

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