Trulicity ® (dulaglutide)

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Were there gastrointestinal adverse events for Trulicity® (dulaglutide) in the AWARD-11 study?

Adverse events (AEs) of dulaglutide are mainly gastrointestinal (GI) in nature and tend to decrease as patients continue a on maintenance dose of dulaglutide.

UK_cFAQ_GLP042_GI_AEs_AWARD-11
UK_cFAQ_GLP042_GI_AEs_AWARD-11
en-GB

What was the incidence of GI AEs with the higher doses of Dulaglutide?

The AWARD-11 trial was a phase 3, randomized, double-blind, active-controlled, parallel-arm study that assessed the efficacy and safety of dulaglutide 3.0 mg and dulaglutide 4.5 mg compared with dulaglutide 1.5 mg in patients with inadequately controlled Type 2 Diabetes on concomitant metformin therapy.1,2

  • Consistent with the known safety profile of GLP-1- receptor agonists, the most common AEs related to dulaglutide treatment were mild to moderate GI symptoms. The incidence was highest early after dulaglutide initiation and tended to wane over time.1-3
  • In a post hoc analysis of AWARD-11, the incidence of GI AEs peaked within 2 weeks of initiating dulaglutide 0.75 mg and decreased over time, with the recommended dose escalation. Few patients who escalated from 1.5 to 3.0 mg and subsequently 4.5 mg in 4-week increments experienced new or additional GI TEAEs.4

Gastrointestinal Adverse Events in Patients Taking Dulaglutide

In single-dose studies, most GI AEs were reported during the first 2 to 3 days after dosing and usually diminished by 7 days of dosing with dulaglutide.3

In multiple-dose studies, these AEs were evaluated in daily and weekly intervals. Most of these AEs were reported during the first 2 to 3 days after the initial dose of dulaglutide and declined over the first week of dosing and after each subsequent dose.3

The most frequently reported TEAEs in AWARD-11 were GI related (Most Frequently Reported GI TEAEs Reported in AWARD-11).1-3,5

Most Frequently Reported GI TEAEs Reported in AWARD-111-3,5

Parameter

DULA 1.5 mg
(n=612)

DULA 3.0 mg
(n=616)

DULA 4.5 mg
(n=614)

Total
(n=1842)

36 weeks

Patients ≥1 TEAE, n (%)

346 (56.5)

351 (57.0)

378 (61.6)

1075 (58.4)

Nausea

82 (13.4)

96 (15.6)

101 (16.4)

279 (15.1)

Diarrhea

43 (7.0)

70 (11.4)

66 (10.7)

179 (9.7)

Vomiting 

34 (5.6)

51 (8.3)

57 (9.3)

142 (7.7)

Dyspepsia

17 (2.8)

31 (5.0)

16 (2.6)

64 (3.5)

52 weeks

Patients ≥1 TEAE, n (%)

380 (62.1)

384 (62.3)

408 (66.4)

1172 (63.6)

Nausea

87 (14.2)

99 (16.1)

106 (17.3)

292 (15.9)

Diarrhea

47 (7.7)

74 (12.0)

71 (11.6)

192 (10.4)

Vomiting

39 (6.4)

56 (9.1)

62 (10.1)

157 (8.5)

Dyspepsia

17 (2.8)

31 (5.0)

17 (2.8)

65 (3.5)

Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; DULA = dulaglutide; GI = gastrointestinal; TEAE = treatment-emergent adverse event.

Escalation from dulaglutide 1.5 mg to dulaglutide 3.0 mg or 4.5 mg once weekly provided a safety and tolerability profile that is comparable to the 1.5 mg once-weekly dulaglutide dose and that of other GLP-1 RAs.2,3,6

Nearly all cases of nausea, vomiting, and diarrhea reported by patients, >95% for each, were mild to moderate in severity.2,3

References

1Frias JP, Nevárez Ruiz L, Li YG, et al. Efficacy and safety of higher dulaglutide doses (3.0 mg and 4.5 mg) when added to metformin in patients with type 2 diabetes: a phase 3, randomized, double-blind, parallel arm study (AWARD-11). J Endocr Soc. 2020;4(suppl 1):A1036. Endocrine Society abstract OR26-08. https://doi.org/10.1210/jendso/bvaa046.2057

2Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg in metformin-treated patients with type 2 diabetes in a randomized controlled trial (AWARD-11). Diabetes Care. 2021;44(3):765-773. https://doi.org/10.2337/dc20-1473

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Van J, Frias JP, Bonora E, et al. Once weekly dulaglutide 3.0 mg and 4.5 mg gastrointestinal tolerability: post-hoc analysis of incidence and prevalence in AWARD-11. Poster presented at: 81st Scientific Sessions of the American Diabetes Association (ADA 2021 Virtual); June 25-29, 2021. Accessed June 4, 2021. https://diabetes.diabetesjournals.org/content/70/Supplement_1/680-P

5Frias JP, Bonora E, Nevarez Ruiz LA, et al. Efficacy and safety of dulaglutide 3mg and 4.5mg vs. dulaglutide 1.5mg: 52-week results from AWARD-11. Diabetes. 2020;69(suppl 1). American Diabetes Association abstract 357-OR. https://doi.org/10.2337/db20-357-OR

6Tham LS, Tang CC, Lim J, et al. Model-based evaluation of nausea and vomiting events for additional doses of dulaglutide in existing and dulaglutide-naïve patients with type 2 diabetes. Poster presented at: 81st Scientific Sessions of the American Diabetes Association (ADA 2021 Virtual); June 25-29, 2021. Accessed June 4, 2021. ---URL---.

Date of Last Review: 17 June 2021


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