When should dulaglutide (Trulicity) be used in the treatment of type 2 diabetes mellitus (DM) and how does it compare to other treatments?

Updated: Jul 13, 2021
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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Dulaglutide (Trulicity) was approved by the FDA in September 2014 as adjunctive therapy to diet and exercise to improve glycemic control in type 2 diabetes mellitus. [213] It is administered as a once-weekly subcutaneous injection. [213, 214] Approval was based on six clinical trials (AWARD studies) involving a total of 3342 patients who received dulaglutide as monotherapy or as part of combination therapy. [213] Dulaglutide was noninferior to daily liraglutide in one study and superior to the oral dipeptidyl peptidase–4 (DPP-4) inhibitor sitagliptin in another. Adverse effects included nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. [213]

AWARD-1 compared dulaglutide weekly doses of 0.75 mg or 1.5 mg compared with exenatide injectable solution BID. The mean A1C reductions were dulaglutide, 1.5 mg, 1.5%; 0.75 mg, 1.3%; exenatide solution, 1.0%; placebo, 0.5%. [214]

In September 2020, the FDA approved higher doses (ie, 3 mg or 4.5 mg weekly) of dulaglutide for patients requiring additional glycemic control. This approval was based on results from the AWARD-11 clinical trial. [215]  

AWARD-3 compared dulaglutide with insulin glargine titrated to target. Mean A1C reductions were dulaglutide 1.5 mg, 1.1-1.6%; 0.75 mg, 0.8-1.6%; and insulin glargine 0.6-1.4%. Dulaglutide was shown to be noninferior as monotherapy compared with metformin in the AWARD-3 trial. Mean A1C reductions were dulaglutide 1.5 mg, 0.8%; dulaglutide 0.75 mg, 0.7%; compared with metformin 0.6%. [216]

AWARD-5 compared dulaglutide with sitagliptin in patients taking metformin. At the 52-week primary endpoint, mean A1C reductions were dulaglutide 1.5 mg, 1.1%; 0.75 mg, 0.9%; compared with sitagliptin 0.4%. [217]

In February 2020, the FDA approved dulaglutide for major adverse cardiovascular (CV) event reduction (with regard to CV death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus in whom established CV disease or multiple CV risk factors are present. Approval stemmed from the REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) study, a multicenter, randomized, double-blind, placebo-controlled trial that found that the incidence of primary composite outcomes (nonfatal myocardial infarction, nonfatal stroke, or CV-related death) was 2.4 per 100 person-years in the dulaglutide group, versus 2.7 per 100 person-years in the placebo group. [218]

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