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Trulicity ® (dulaglutide)
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Trulicity Summary of Product Characteristics (SmPC)
Does Trulicity® (dulaglutide) cause nausea and how should it be treated?
Nausea (feeling sick) is a very common side effect of Trulicity that usually goes away over time.
UK_cFAQ_GLP057_NAUSEA
en-GB
How should Nausea be treated in Patients ?
In clinical studies with dulaglutide, management of nausea consisted of symptomatic treatment such as antiemetics and antacids as per usual standards of care.1
When does Nausea occur and how long does it last?
In clinical pharmacology studies conducted in patients with Type 2 Diabetes mellitus, nausea was generally
Gastrointestinal adverse events, including nausea were
- reported to peak during the first 2 weeks of treatment, and
- rapidly declined over the next 4 weeks (Onset of Nausea With Once-Weekly Dulaglutide Treatment in the AWARD-1, AWARD-5, and GBDN* Studies)1.
Abbreviation: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes.
*Note: GBDN was an ambulatory blood pressure monitoring safety study.
Did Nausea lead to Study Drug Discontinuation?
In phase 2 and 3 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
How often was Nausea reported in the Clinical Trials?
In the pooled data derived from the 3 placebo-controlled trials of 26 weeks duration or longer, nausea was reported in
- 21.1% of patients receiving dulaglutide 1.5 mg
- 12.4% of patients receiving dulaglutide 0.75 mg, and
- 5.3% of patients receiving placebo.3
Across 8 clinical studies, AWARD-1 through AWARD-8 ( Percent of Patients Experiencing Nausea in AWARD studies ), the percent of patients experiencing nausea ranged between
Study |
Dulaglutide 1.5 mg |
Dulaglutide 0.75 mg |
AWARD-3 5– Comparator – Metformin (MET) |
||
26 weeks |
19.0% |
10.7% |
AWARD-56– Comparator – Sitagliptin and Placebo |
||
52 weeks |
17.0%a |
13.0%a |
AWARD-67– Comparator – Liraglutide |
||
26 weeks |
20.0% |
N/A |
AWARD-88 – Comparator – Placebo |
||
24 weeks |
10.5%b |
N/A |
AWARD-19 – Comparator – Exenatide (twice daily) and Placebo |
||
26 weeks |
28.0%b |
|
AWARD-210– Comparator – Insulin glargine (GLA)d |
||
52 weeks |
14.3%e |
6.6%e |
AWARD-911 – Comparator – Placebo |
||
28 weeks |
12.0%b |
N/A |
AWARD-4 12– Comparator – Insulin glargined |
||
26 weeks |
26.0%e |
18.0%e |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; GLA = insulin glargine; GLIM = glimepiride; MET = Metformin; N/A = not applicable;
asignificant vs sitagliptin.
bsignificant vs placebo.
csignificant vs exenatide.
dtitrated
esignificant vs glargine.
Nausea in the AWARD-11 Study
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 to dulaglutide 1.5 mg in patients with inadequately controlled T2DM on concomitant metformin therapy.13
In the AWARD-11 study, through 52 weeks of treatment with dulaglutide, a total of 292 patients experienced nausea where
- 87 patients, 14.2%, were receiving 1.5 mg dulaglutide
- 99 patients, 16.1%, were receiving 3 mg dulaglutide, and
- 106 patients, 17.3%, were receiving 4.5 mg dulaglutide.13-15
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Martin 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.
3Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
4Kugler 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://doi.org/10.2147/DMSO.S134960
5Umpierrez G, Povedano ST, Manghi FP, 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
6Nauck 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
7Dungan 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. https://doi.org/10.1016/S0140-6736(14)60976-4
8Dungan 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
9Wysham 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
10Giorgino 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
11Pozzilli 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
12Blonde 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
13Frias 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
14Frias 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
15Frias JP, Bonora E, Ruiz LN, et al. Efficacy and safety of dulaglutide 3 mg and 4.5 mg vs dulaglutide 1.5 mg: 52-week results from AWARD-11. Oral presentation presented at: 80th Annual Meeting of the American Diabetes Association; June 12-16, 2020. Accessed September 15, 2020.
Date of Last Review: September 23, 2020
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