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Trulicity ® (dulaglutide)
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Trulicity Summary of Product Characteristics (SmPC)
Trulicity® (dulaglutide): Long-term Safety
Both dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment doses reported more treatment-emergent adverse events than the sitagliptin treatment group
The AWARD-5 study was an adaptive, multicenter, randomized, 104-week, double-blind study that compared once-weekly dulaglutide 1.5 mg and dulaglutide 0.75 mg treatments with once-daily sitagliptin 100 mg and placebo in patients with T2DM inadequately controlled with metformin.1,2
Treatment with dulaglutide was associated with a significantly higher incidence of GI TEAEs than treatment with sitagliptin (p<.05).1,2
Nausea, diarrhea, and vomiting were the most commonly reported AEs with the incidence highest after 2 weeks of treatment and decreased at the following visits.1
Both dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment doses reported more TEAEs than the sitagliptin treatment group due to greater incidence of GI AEs (Table 1).1
A similar incidence of serious AEs was reported across treatment groups (Table 1).1
Table 1. Adverse Events From Baseline to 104 Weeks in Patients Treated With Dulaglutide 1.5 mg, Dulaglutide 0.75 mg, or Sitagliptin 100 mg in the AWARD-5 Study 1,3
|
Variablea |
DULA
1.5 mg |
DULA
0.75 mg |
SITA
100 mg |
|
Treatment-emergent adverse events ≥1 |
259 (85) |
255 (84) |
242 (77) |
|
Treatment-emergent GI adverse events |
|||
|
Nausea |
53 (17) |
44 (15) |
21 (7) |
|
Vomiting |
41 (14) |
25 (8) |
11 (4) |
|
Diarrhea |
49 (16) |
36 (12) |
18 (6) |
|
Abdominal pain |
21 (7) |
13 (4) |
11 (4) |
|
Abdominal distention |
13 (4) |
15 (5) |
3 (1) |
|
Dyspepsia |
18 (6) |
19 (6) |
14 (4) |
|
Pancreatic enzymes, median (Q1,Q3) [U/I] |
|||
|
Lipase |
6 (-1,14) |
6 (-1,18) |
3 (-2,9) |
|
Total amylase |
6 (-1,15) |
7 (-1,17) |
3 (-3,12) |
|
p-Amylase |
4 (0,9) |
4 (0,11) |
2 (-1,7) |
|
Pancreatitis |
0 (0) |
0 (0) |
2 (0.6) |
|
Serious adverse events |
36 (12) |
23 (8) |
32 (10) |
|
Infections and infestations |
7 (2) |
3 (1) |
5 (2) |
|
Cardiac disorders |
6 (2) |
2 (1) |
4 (1) |
|
Neoplasms |
5 (2) |
3 (1) |
5 (2) |
|
Gastrointestinal events |
4 (1) |
2 (1) |
4 (1) |
|
Renal/urinary disorders |
5 (2) |
2 (1) |
0 (0) |
|
Death |
1 (<1) |
0 (0) |
2 (1) |
|
Injection site reactions |
4 (1.3) |
3 (1.0) |
3 (1.0) |
|
Hypoglycemiab, mean (SD) |
|||
|
Total |
0.0 (0.2) |
0.0 (0.5) |
0.0 (0.3) |
|
Documented symptomatic |
0.0 (0.1) |
0.0 (0.5) |
0.0 (0.3) |
|
Discontinuation resulting from adverse events |
63 (21) |
64 (21) |
65 (21) |
|
Vital signs, LSM (SE) |
|||
|
Systolic blood pressure, mmHg |
-0.1 (0.8) |
1.3 (0.8) |
<0.1 (0.8) |
|
Diastolic blood pressure, mmHg |
0.4 (0.5) |
1.4 (0.5) |
-0.4 (0.5) |
|
Pulse rate, beats/min |
2.3 (0.5) |
2.8 (0.5) |
-0.8 (0.5) |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; DULA = dulagultide; GI = Gastrointestinal; LSM = least squares mean; Q1 = first quartile; Q3 = third quartile; SITA = Sitagliptin; U/l = units per liter.
a Data presented as n (%) unless otherwise indicated.
b <54 mg/dL cutoff, 1-year adjusted rate.
1. Weinstock RS, Guerci B, Umpierrez G, et al. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015;17(9):849-858. http://dx.doi.org/10.1111/dom.12479
2. 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
3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AE = adverse event
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
GI = gastrointestinal
T2DM = type 2 diabetes mellitus
TEAE = treatment-emergent adverse event
Date of Last Review: January 06, 2021
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