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Trulicity ® (dulaglutide)
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How does Trulicity® (dulaglutide) affect gastric emptying?
Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products.
UK_cFAQ_GLP025_GASTRIC_EMPTYING
en-GB
Gastric emptying in clinical pharmacology studies
The gastric emptying delay with dulaglutide administration has been demonstrated in 3 clinical pharmacology studies.1-3
In the first study, patients with type 2 diabetes mellitus (T2DM) were assigned to 1 of 6 dulaglutide doses that included
- 0.05 mg
- 0.3 mg
- 1 mg
- 3 mg
- 5 mg, and
- 8 mg.
On 2 occasions, oral paracetamol (acetaminophen) was administered and gastric emptying was assessed by following the absorption of paracetamol.1
The maximum average delay in the time to maximum plasma concentration (tmax) of paracetamol was approximately 1.5 hours, and there was a significant difference in the ratio LSM (least square mean) of predose to postdose tmax observed between dulaglutide 8 mg and placebo (tmax, 2.31; 90% CI: 1.28, 4.18). The results of the study suggested that gastric emptying was delayed by treatment with dulaglutide.1
In the second study, healthy subjects were assigned to dulaglutide 1 mg or dulaglutide 3 mg and received paracetamol on 2 occasions to assess pharmacokinetics (PKs). Steady-state levels of dulaglutide had no clinically significant effect on the rate or extent of gastric emptying according to the PKs of paracetamol. However, the rate of gastric emptying
- was decreased after the first dulaglutide dose (reduced maximum plasma concentratrion (Cmax) of paracetamol: 1 mg, 36%; 3 mg, 50%), and
- delayed the tmax of paracetamol (1 mg, 3 hours; 3 mg, 4 hours).2
In the third study, scintigraphy was used in patients with T2DM to assess t50, defined as the time required for 50% of activity from a radiolabeled meal to empty from the stomach. Compared with baseline, delays in gastric emptying rate were observed following each of 4 dulaglutide 1.5 mg doses. The effect was most pronounced after the first dose of dulaglutide, with a mean increase in
- t50 from 1.72 hours (on day 3, after placebo) to 3.77 hours (on day 10, after the first dose of dulaglutide), and
- a corresponding 2.4-fold increase in area under the curve AUC for residual activity.3
The results demonstrated that dulaglutide treatment delays gastric emptying by approximately 2 hours where the effect is largest after the first dose and diminishes with subsequent doses.3
Effects of dulaglutide on pharmacokinetics of other drugs
In the clinical pharmacology studies described below, dulaglutide doses up to 1.5 mg did not affect the absorption of the orally administered medicinal products tested to any clinically relevant degree:4
- warfarin
- metformin
- lisinopril or metoprolol
- digoxin
- paracetamol
- norgestimate/norelgestromin and ethinylestradiol
- sitagliptin, and
- atorvastatin.
For the 4.5 mg dose, absence of major clinically relevant interactions was predicted by physiologically-based pharmacokinetic (PBPK) modelling simulations.4
For patients receiving dulaglutide in combination with oral medicinal products with rapid gastrointestinal absorption or prolonged release, there is a potential for altered medicinal product exposure, particularly at the time of dulaglutide treatment initiation.4
Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.4
References
1Barrington P, Chien JY, Showalter HD, et al. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011;13(5):426-433. https://doi.org/10.1111/j.1463-1326.2011.01364.x
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Loghin C, de la Pena A, Cui X, Chien J. Gastric emptying effects of once weekly dulaglutide in patients with type 2 diabetes mellitus. Poster presented at: 23rd Annual American Association of Clinical Endocrinologists (AACE) Scientific and Clinical Congress: May 10-14, 2014; Las Vegas, NV.
4Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
Date of Last Review: 10 September 2020
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