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Cited by 284Diabetes Treatment and ManagementDiabetes Management and ResearchPharmacology and Obesity Treatment

Efficacy and Safety of Dulaglutide Versus Sitagliptin After 52 Weeks in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-5)

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Nauck, Michael, Weinstock, Ruth S., Umpierrez, Guillermo E., Guerci, Bruno, Skrivanek, Zachary, Milicevic, Zvonko·2014·Diabetes Care
DOI 10.2337/dc13-2761PMC PMC4113177
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Abstract

OBJECTIVE: To compare the efficacy and safety of two doses of once-weekly dulaglutide, a glucagon-like peptide 1 receptor agonist, to sitagliptin in uncontrolled, metformin-treated patients with type 2 diabetes. The primary objective was to compare (for noninferiority and then superiority) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c (HbA1c) at 52 weeks. RESEARCH DESIGN AND METHODS: This multicenter, adaptive, double-blind, parallel-arm study randomized patients (N = 1,098; mean baseline age 54 years; HbA1c 8.1% [65 mmol/mol]; weight 86.4 kg; diabetes duration 7 years) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, sitagliptin 100 mg, or placebo (placebo-controlled period up to 26 weeks). The treatment period lasted 104 weeks, with 52-week primary end point data presented. RESULTS: The mean HbA1c changes to 52 weeks were (least squares mean ± SE): −1.10 ± 0.06% (−12.0 ± 0.7 mmol/mol), −0.87 ± 0.06% (9.5 ± 0.7 mmol/mol), and −0.39 ± 0.06% (4.3 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg, and sitagliptin, respectively. Both dulaglutide doses were superior to sitagliptin (P < 0.001, both comparisons). No events of severe hypoglycemia were reported. Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg (−3.03 ± 0.22 kg) and dulaglutide 0.75 mg (−2.60 ± 0.23 kg) compared with sitagliptin (−1.53 ± 0.22 kg) (P < 0.001, both comparisons). The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5- and 0.75-mg arms were nausea, diarrhea, and vomiting. CONCLUSIONS: Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile.

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  • GLP-1RAs may have side effects including nausea, vomiting, diarrhea, and injection site reactions, which are often mild and tend to improve over time.

    “Like any medication, GLP-1RAs may have side effects, including nausea, vomiting, diarrhea, and injection site reactions. These side effects are often mild and tend to improve over time.72–74”

    From Glucagon-like peptide-1 receptor: mechanisms and advances in therapy (2024) · cites this paper as [74]

    Results > Safety reports nausea, vomiting, and diarrhea with dulaglutide and says their incidence peaked in the first two weeks, then declined. The copy does not establish that these effects were often mild, and Conclusions reports no injection-site hypersensitivity reactions in antibody-positive patients rather than documenting injection-site reactions as a side effect. The trial also concerns dulaglutide specifically, not GLP-1 receptor agonists generally. (LLM, conf=0.86)

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  • GLP-1RAs have modest beneficial effects on fasting plasma lipid levels in patients with T2DM.

    “GLP-1RAs have shown modest beneficial effects on fasting plasma lipid levels in patients with T2DM [36, 37].”

    From Protection against stroke with glucagon-like peptide-1 receptor agonists: a comprehensive review of potential mechanisms (2022) · cites this paper as [36]

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  1. [18]Skrivanek Z Chien JY Gaydos B Heathman M Geiger MJ Milisevic Z Dose finding results in an adaptive trial of dulaglutide combined with metformin in type 2 diabetes (AWARD-5). Diabetologia 2013; 56(Suppl. 1): S402 24762094

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Authors
Nauck, M., Weinstock, R. S., Umpierrez, G. E., Guerci, B., Skrivanek, Z., & Milicevic, Z.
Affiliations
  • Diabeteszentrum Bad Lauterberg (DE)
  • SUNY Upstate Medical University (US)
  • Emory University (US)
  • Centre Hospitalier Régional et Universitaire de Nancy (FR)
  • Eli Lilly (United States) (US)
  • Lilly Diabetes, Eli Lilly and Company, Vienna, Austria
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2014-07-12
Volume
37
Issue
8
Pages
2149-2158
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc13-2761
PMC
PMC4113177
OpenAlex
W2090054860
Cited by
284
References
40
Citations by year
2026: 12 · 2025: 15 · 2024: 15 · 2023: 23 · 2022: 10 · 2021: 16 · 2020: 25 · 2019: 21 · 2018: 30 · 2017: 32 · 2016: 34 · 2015: 41 · 2014: 10
FWCI
31.39
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (UL1TR000454)
  • National Center for Research Resources (M01-RR00039, UL1RR025008, M01RR000039)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
dulaglutide, sitagliptin, type 2 diabetes, GLP-1 receptor agonists, DPP-4 inhibitors, HbA1c, non-inferiority, weight loss, hypoglycemia, gastrointestinal adverse effects, metformin, dose comparison, long-term glycemic control, drug safety and efficacy
MeSH terms
Sitagliptin Phosphate, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Glucagon-Like Peptides, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Immunoglobulin Fc Fragments, Male, Metformin, Middle Aged, Pyrazines, Recombinant Fusion Proteins, Triazoles, Treatment Outcome, Glucagon-Like Peptide 1

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