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Trulicity ® (dulaglutide)
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What adverse events were commonly reported in the pediatric study for Trulicity® (dulaglutide)?
In AWARD-PEDS, the incidence of nausea, vomiting, headache and diarrhea was higher in patients treated with dulaglutide compared to placebo, however, the incidence was comparable to that observed in adults.
AWARD-PEDS: Safety
AWARD-PEDS was a phase 3, randomized, placebo-controlled study that assessed the efficacy and safety of dulaglutide 0.75 mg and 1.5 mg in pediatric patients, ages 10 to less than 18 years old, with inadequately controlled type 2 diabetes despite diet and exercise, with or without metformin and/or basal insulin.1
The primary endpoint of AWARD-PEDS was to show superiority of dulaglutide (0.75 mg and 1.5 mg, pooled doses) versus placebo for change in glycated hemoglobin (HbA1c) at 26 weeks.1
Overall, the safety findings from AWARD-PEDS were consistent with the safety profile observed in adults.1
Treatment-Emergent Adverse Events
In AWARD-PEDS, the most commonly reported treatment-emergent adverse events in the dulaglutide treatment groups were diarrhea, headache, nausea, and vomiting (Treatment-Emergent Adverse Events Through 26 Weeks in AWARD-PEDS).1
TEAEa |
Pooled DULA |
DULA 1.5 mg |
DULA 0.75 mg |
PBO |
Any TEAE |
76 (74) |
38 (73) |
38 (75) |
35 (69) |
TEAEs reported in ≥5% of patientsb |
||||
Diarrhea |
19 (18) |
11 (21) |
8 (16) |
7 (14) |
Headache |
15 (15) |
8 (15) |
7 (14) |
5 (10) |
Nausea |
15 (15) |
8 (15) |
7 (14) |
4 (8) |
Vomiting |
16 (16)c |
7 (13) |
9 (18) |
2 (4) |
Upper abdominal paind |
8 (8) |
5 (10) |
3 (6) |
4 (8) |
Upper respiratory tract infection |
8 (8) |
6 (12) |
2 (4) |
4 (8) |
Nasopharyngitis |
7 (7) |
2 (4) |
5 (10) |
3 (6) |
Abdominal paine |
5 (5) |
1 (2) |
4 (8) |
3 (6) |
Abbreviations: AWARD-PEDS = Assessment of Weekly AdministRation of LY2189265 in Diabetes – PEDiatric Study; DULA = dulaglutide; PBO = placebo; TEAE = treatment-emergent adverse event.
aData presented as n (%).
bIndividual adverse events are shown as Medical Dictionary for Regulatory Activities version 24.1 preferred terms.
cp<.05 vs PBO (Fisher's Exact test).
dUpper abdominal pain included events that were reported by investigators as stomachache, intermittent stomachache, epigastric pain, stomach pain, and stomach cramps.
eAbdominal pain included events that were reported by investigators as abdominal pain, abdominal cramping, colic, and intermittent right side abdominal pain.
Through 26 weeks of treatment, a serious adverse event was reported for
- 2% (n=1) of patients receiving dulaglutide 1.5 mg
- 2% (n=1) of patients receiving dulaglutide 0.75 mg, and
- 6% (n=3) of patients receiving placebo.1
Through 26 weeks, 2 patients receiving dulaglutide 1.5 mg and 1 patient receiving dulaglutide 0.75 mg discontinued treatment due to an adverse event compared with 1 patient who was receiving placebo.1
Hypoglycemia
Parametera |
Pooled DULA |
DULA 1.5 mg |
DULA 0.75 mg |
PBO |
Documented symptomatic hypoglycemiab |
8 (8) |
3 (6) |
5 (10) |
6 (12) |
Plasma glucose <3.0 mmol/L [<54 mg/dL] |
4 (4) |
2 (4) |
2 (4) |
1 (2) |
Severe hypoglycemiac |
0 |
0 |
0 |
0 |
Abbreviations: AWARD-PEDS = Assessment of Weekly AdministRation of LY2189265 in Diabetes – PEDiatric Study; DULA = dulaglutide; PBO = placebo.
aData presented as n (%).
bPlasma glucose <3.9 mmol/L [<70 mg/dL].
cDefined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Pancreatic Enzymes
In AWARD-PEDS, patients receiving dulaglutide experienced greater mean changes from baseline in pancreatic enzyme levels through 26 weeks compared with patients receiving placebo (Mean Change in Pancreatic Enzymes From Baseline To 26 Weeks in AWARD-PEDS).1
Parametera |
Pooled DULA |
DULA 1.5 mg |
DULA 0.75 mg |
PBO |
Pancreatic amylase, IU/L |
2.3 |
2.9 |
1.8 |
0.6 |
Lipase, IU/L |
4.1 |
3.9 |
4.4 |
2.2 |
Abbreviations: AWARD-PEDS = Assessment of Weekly AdministRation of LY2189265 in Diabetes – PEDiatric Study; DULA = dulaglutide; PBO = placebo.
aData presented as mean change from baseline.
There were no reported cases of pancreatitis in AWARD-PEDS.1
References
1Arslanian SA, Hannon T, Zeitler P, et al; AWARD-PEDS Investigators. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med. 2022;387(5):433-443. https://doi.org/10.1056/NEJMoa2204601
Date of Last Review: 27 April 2022