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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.
How should Trulicity® (dulaglutide) doses be increased?
Dulaglutide should be initiated at 0.75 mg once weekly. If additional glycemic control is needed, increase the dose according to proper dose escalation schedule.
See important safety information, including boxed warning, in the attached prescribing information.
Dose Escalation
Eli Lilly and Company (Lilly) does not recommend initiating dulaglutide treatment at the 3 mg or 4.5 mg dose. The recommended initiating dose for dulaglutide is 0.75 mg once weekly.1
Adult Dosage
Dulaglutide-Naïve Patients
The recommended starting dosage of dulaglutide is 0.75 mg injected subcutaneously once weekly.2
Increase the dosage to 1.5 mg once weekly for additional glycemic control.1
If additional glycemic control is needed, increase the dosage in 1.5 mg increments after at least 4 weeks on the current dosage.1
The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.1
Previous Dulaglutide Therapy
Lilly has not sponsored a study where patients who were receiving dulaglutide were de-escalated to a lower dose and then later escalated back to a higher dose of medication.
If patients have previously experienced dulaglutide therapy, they should follow the same dose escalation schedule as recommended in the United States Prescribing Information.1
The recommended starting dosage of dulaglutide is 0.75 mg injected subcutaneously once weekly.2
Increase the dosage to 1.5 mg once weekly for additional glycemic control.1
If additional glycemic control is needed, increase the dosage in 1.5 mg increments after at least 4 weeks on the current dosage.1
The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.1
Pediatric Dosage (Patients 10 Years of Age and Older)
The safety and effectiveness of dulaglutide have not been established in pediatric patients less than 10 years of age.1
The recommended starting dosage of dulaglutide is 0.75 mg injected subcutaneously once weekly.1
If additional glycemic control is needed, increase the dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage.1
Study Escalation Protocols
Adults
Adult studies of dulaglutide 0.75 mg and 1.5 mg were conducted with immediate initiation at these doses without dose escalation. The AWARD-11 phase 3 study with 3.0 mg and 4.5 mg included stepwise escalation of dulaglutide doses from 0.75 mg to 1.5 mg, 3.0 mg, and 4.5 mg consistent with the United States prescribing information.1,3
The AWARD-11 trial was a phase 3, randomized, double-blind, active-controlled, parallel-arm study that assessed the efficacy and safety of dulaglutide 3.0 mg and dulaglutide 4.5 mg compared with dulaglutide 1.5 mg in patients with inadequately controlled type 2 diabetes on concomitant metformin therapy.3
Patients were treated for 52 weeks, which included a 12-week dose-escalation phase ().2
Pediatrics
AWARD-PEDS was a phase 3, randomized, placebo-controlled study that assessed the efficacy and safety of dulaglutide 0.75 mg and 1.5 mg in pediatric patients, ages 10 to less than 18 years old, with inadequately controlled type 2 diabetes despite diet and exercise, with or without metformin and/or basal insulin.4
In AWARD-PEDS, patients who were randomized to dulaglutide 1.5 mg were initiated at the 0.75 mg dose for 4 weeks, then escalated to dulaglutide 1.5 mg.4
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg in metformin-treated patients with type 2 diabetes in a randomized controlled trial (AWARD-11). Diabetes Care. 2021;44(3):765-773. https://doi.org/10.2337/dc20-1473
4Arslanian SA, Hannon T, Zeitler P, et al; AWARD-PEDS Investigators. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med. 2022;387(5):433-443. https://doi.org/10.1056/NEJMoa2204601
Date of Last Review: November 21, 2022