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Trulicity ® (dulaglutide) injection
0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3mg/0.5mL, 4.5mg/0.5mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Has Trulicity® (dulaglutide) been associated with increases in QTc interval?
The effect of dulaglutide on cardiac repolarization was tested in a thorough QTc study. Dulaglutide did not produce QTc prolongation at doses of 4 and 7 mg. The maximum recommended dose is 4.5 mg once weekly.
See important safety information, including boxed warning, in the attached prescribing information.
QT and QTc Interval
A double-blind, randomized, placebo-controlled, 3-period, crossover study evaluated cardiac repolarization as assessed by corrected QT interval (QTc) using a single, supratherapeutic dose of dulaglutide in 147 healthy subjects.1
Subjects received a single dose of dulaglutide 4 mg or dulaglutide 7 mg, moxifloxacin 400 mg and placebo separately with a washout period of approximately 21 days between the administration of each study treatment.1
Both doses of dulaglutide were expected to provide a supratherapeutic exposure of at least 5 times the steady-state concentration when once-weekly dulaglutide 1.5 mg was administered in patients with type 2 diabetes.1
The change in QT interval from pre-dose to 24-, 48-, 72-, and 168-hours post-dose was corrected for heart rate using Fridericia's and other methods.1
The upper limit of the 2-sided 90% CI was less than 10 milliseconds for the time-matched mean difference between dulaglutide and placebo for all correction methods used.1
Dulaglutide did not produce QTc prolongation at doses of 4 mg and 7 mg.2
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Loghin C, Chien JY, Cui S, et al. LY2189265, a long-acting GLP-1 analog, does not prolong QTc interval in healthy subjects at supratherapeutic doses. Diabetes. 2011;60(suppl 1):A299. American Diabetes Association abstract 1089-P. http://diabetes.diabetesjournals.org/content/diabetes/60/Supplement_1/A235.full.pdf
2Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
Date of Last Review: October 17, 2022