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

Updated: Oct 23, 2019
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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Answer

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. [174] It is administered as a once-weekly subcutaneous injection. [174, 175] 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. [174] 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. [174]

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%. [175]

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%. [176]

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%. [177]


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