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Trulicity ® (dulaglutide)
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Can multiple Trulicity® (dulaglutide) injections be used to make a larger dose?
Lilly does not recommend using multiple dulaglutide injections to make a larger dose. Multiple injections of lower doses were studied in a phase 2 study as part of the development of higher doses but combining multiple dose injections is not recommended.
Administering Multiple Injections
Administering multiple injections of dulaglutide has not been tested in a phase 3 clinical study, so there is limited evidence to support the efficacy and safety of administering multiple injections to create a higher dose. Using multiple dulaglutide injections is not captured in the Summary of Product Characteristics; therefore, Eli Lilly and Company does not recommend using multiple lower dose injections.1,2
Combining Injections in a Phase 2 Study
The phase 2 study, GBGJ, compared dulaglutide 1.5 mg, 3.0 mg, and 4.5 mg with placebo. Patients randomized to dulaglutide 3.0 mg received two 1.5 mg doses, and patients randomized to dulaglutide 4.5 mg dose received three 1.5 mg doses.1,3
Efficacy and safety results of this phase 2 trial led to further development and completeness of the phase 3 study, AWARD-11, which was the basis for the approval of the higher doses.1
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
3Frias JP, Wynne AG, Matyjaszek-Matuszek B, et al. Efficacy and safety of an expanded dulaglutide dose range: a phase 2, placebo-controlled trial in patients with type 2 diabetes using metformin. Diabetes Obes Metab. 2019;21(9):2048-2057. https://doi.org/10.1111/dom.13764
Date of Last Review: 14 January 2022