Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

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Trulicity® (dulaglutid): Användning med DPP-4-hämmare

Användningen av sitagliptin i kombination med Trulicity (dulaglutid) har inte utvärderats i kliniska studier.

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 delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products.2

Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide. Following coadministration with 2 consecutive doses of dulaglutide, resulted in a decrease of the sitagliptin

  • AUC(0-τ) and by approximately 7.4 %

  • Cmax by approximately 23.1 %,.

Sitagliptin tmax increased approximately 0.5 hours following coadministration with dulaglutide compared to sitagliptin alone.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

Figure 1. Impact of Dulaglutide on the Pharmacokinetics of Coadministered Dipeptidyl Peptidase-4 Inhibitor, Sitagliptin1

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

Sitagliptin can produce up to 80 % inhibition of DPP‑4 over a 24‑hour period.2

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 

Therefore, dulaglutide does have a high degree of protection against DPP‑4 inactivation. The increased exposure may enhance the effects of dulaglutide on blood glucose levels.2

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 [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

Datum fӧr senaste ӧversyn 2020 M01 08


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