Trulicity ® (dulaglutide)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Trulicity Summary of Product Characteristics (SmPC)

Trulicity ® (dulaglutide): Nausea in clinical trials

Gastrointestinal adverse events, including nausea, were the most frequently reported adverse reactions in clinical trials with dulaglutide.

Detailed Information

Gastrointestinal AEs, including nausea, were the most frequently reported adverse reactions in clinical trials with dulaglutide.1

Similarly, in clinical pharmacology studies conducted in patients with T2DM, nausea was generally reported during the first 2 to 3 days after the initial dose and declined with subsequent doses.1,2

In the pooled data derived from the 3 placebo-controlled trials of 26 weeks duration or longer, nausea was reported in

  • 21.2% of patients receiving dulaglutide 1.5 mg, and

  • 12.9% of patients receiving dulaglutide 0.75 mg 1

In the 6 placebo- and/or active-controlled studies, the incidence of nausea leading to discontinuation was

  • 1.9% for dulaglutide 1.5 mg, and

  • 1.0% for dulaglutide 0.75 mg.1

Through the 8 clinical studies, the percent of patients experiencing nausea ranged between

Table 1.  Percent of Patients Experiencing Nausea in AWARD studies 3

Study 

Dulaglutide 1.5 mg 

Dulaglutide 0.75 mg 

AWARD-3 5– Comparator – MET

26 weeks

19.0%

10.7% 

AWARD-56– Comparator – SITA and PBO 
Background anti-diabetic medications: MET ≥ 1,500 mg/day

52 weeks

17.0%a

13.0%a

AWARD-67– Comparator – LIRA 
Background anti-diabetic medications: MET ≥ 1,500 mg/day

26 weeks

20.0% 

N/A 

AWARD-88 – Comparator – PBO
Background anti-diabetic medications: GLIM

24 weeks

10.5%b

N/A 

AWARD-19 – Comparator – EXE BID and PBO
Background anti-diabetic medications: MET ≥ 1,500 mg/day and PIO 30-45 mg/day

26 weeks

28.0%b

16%bc

AWARD-210– Comparator – GLAd
Background anti-diabetic medications: MET ≥ 1,500 mg/day and GLIM ≥ 4 mg/day

52 weeks

14.3%e

6.6%e

AWARD-911 – Comparator – PBO
Background anti-diabetic medications: GLAd with or without  MET ≥ 1,500 mg/day

28 weeks

12.0%b

N/A 

AWARD-4 12– Comparator – GLAd
Background anti-diabetic medications: MET ≥ 1,500 mg/day and LISd

26 weeks

26.0%e

18.0%e

Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BID = twice daily; DULA = dulaglutide; EXE = exenatide; GLA = insulin glargine; GLIM = glimepiride; LIRA = liraglutide; LIS = insulin lispro; LSM = least squares mean; MET = metformin; N/A = not applicable; PBO = placebo; PIO= pioglitzaone; SGLT-2 = sodium-glucose contransporter-2; SITA = sitagliptin.

a significant vs sitagliptin.

b significant vs placebo.

c significant vs exenatide.

d titrated

e significant vs glargine.

Nausea was reported to peak during the first 2 weeks of treatment and rapidly decline over the next 4 weeks (Figure 1. Percent of Patients With Nausea Symptoms Throughout Treatment in AWARD-1 to 5 and Study GBDN* ).1

Figure 1. Percent of Patients With Nausea Symptoms Throughout Treatment in AWARD-1 to 5 and Study GBDN* 4

Abbreviation: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes.

* GBDN was an ambulatory blood pressure monitoring safety study.

References

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

2. Martin S, Loghin C, Cui X, et al. The nausea profile of once weekly dulaglutide 1.5 mg. Poster presented at: American Association of Pharmaceutical Scientists Annual Meeting and Exposition: November 2-6, 2014. San Diego, CA. Poster W5273.

3. Kugler AJ, Thiman ML. Efficacy and safety profile of once-weekly dulaglutide in type 2 diabetes: a report on the emerging new data. Diabetes Metab Syndr Obes. 2018;11:187-197. https://dx.doi.org/10.2147/DMSO.S134960

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37(8):2168-2176. https://doi.org/10.2337/dc13-2759

6. Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761

7. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. http://dx.doi.org/10.1016/S0140-6736(14)60976-4

8. Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634

9. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8):2159-2167. https://doi.org/10.2337/dc13-2760

10. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249. https://doi.org/10.2337/dc14-1625

11. Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937

12. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9

Glossary

AE = adverse event

dulaglutide = Trulicity® (dulaglutide)

T2DM = type 2 diabetes mellitus

Date of Last Review: November 20, 2018

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