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.

Can Trulicity® (dulaglutide) be used with DPP-4 Inhibitors?

The use of sitagliptin in combination with Trulicity (dulaglutide) was not evaluated in clinical studies.

Detailed Information

The use of DPP-4 inhibitors, such as sitagliptin, in combination with dulagutide, was not evaluated in the clinical studies assessing dulaglutide.

Coadministration of Dulaglutide With Sitagliptin

An open-label, 2-period, crossover, clinical pharmacology study was done in 29 patients with T2DM that evaluated the mutual effects on the PK of both dulaglutide 1.5 mg and sitagliptin 100 mg.1

Potential for Dulaglutide to Influence the Pharmacokinetics of Sitagliptin

Dulaglutide is a human GLP-1 RA that causes a delay in gastric emptying.2

The delay is longest after the first dose of dulaglutide diminishes with subsequent doses.2

Because dulaglutide slows gastric emptying, it may reduce the extent and rate of absorption of orally coadministered medications.2

Caution should be exercised when oral medications are taken concomitantly with dulaglutide.2

Based on the analysis,

  • no clinically significant effect on the PK of sitagliptin was seen, and

  • no dose adjustment was recommended for sitagliptin when coadministered with dulaglutide (Figure 1).1,2

Figure 1. Impact of Dulaglutide on the Pharmacokinetics of Coadministered Dipeptidyl Peptidase-4 Inhibitor, Sitagliptin2

Abbreviations: AUC = area under the time-concentration curve; Cmax = maximum concentration; PK = pharmacokinetic.
Note: Reference group is coadministered medication given alone.

Potential for Coadministered Sitagliptin to Influence the Pharmacokinetics of Dulaglutide

Compared to dulaglutide being taken alone, the coadministration of a single dose of dulaglutide 1.5 mg with steady-state sitagliptin 100 mg resulted in dulaglutide's increase in 

  • the area under the AUC by approximately 38%

  • Cmax by approximately 27%, and

  • Tmax concentration of approximately 24 hours.1 2

The authors did not consider these differences in the PK profile clinically relevant.1

Enclosed Prescribing Information

TRULICITY® (dulaglutide) injection, for subcutaneous use, Lilly

References

1. Geiser J, de la Peña A, Cui X, et al. No dose adjustment is needed when coadministering dulaglutide with once-daily sitagliptin. Poster presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting: March 15-18, 2017; Washington, D.C.

2. Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

Glossary

AUC = area under the curve

Cmax = maximum plasma concentration

DPP-4 = dipeptidyl peptidase-4

GLP-1 RA = glucagon-like peptide-1 receptor agonist

PK = pharmacokinetic

T2DM = type 2 diabetes mellitus

Tmax = time to maximum concentration

Date of Last Review: June 24, 2020

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