parallel randomized trial

AWARD-PEDS

A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)

Children and adolescents with type 2 diabetes NCT02963766S000604

Design

Randomized: 154
Start year: 2016
Treatment: 26 weeks, follow-up 56 weeks
Countries: Brazil, France, Germany, India, Mexico, Puerto Rico, Saudi Arabia, Turkey, United Kingdom, United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: children and adolescents with type 2 diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: modified itt
Missing data: mixed model

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: not reported	51	45	47
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	lifestyle: not reported	51	50	49
A3	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	lifestyle: not reported	52	50	50

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Dulaglutide 0.75 mg subcutaneous once weekly A2	Dulaglutide 1.5 mg subcutaneous once weekly A3
age	mean (years)	14.20	14.70	14.70
age	sd (years)	2.08	2.21	1.81
asian	n	11	4	4
black	n	5	9	9
female	n	41	35	34
hba1c	mean (percent)	8.14	7.92	8.16
hba1c	sd (percent)	1.12	1.27	1.39
hispanic	n	26	31	28
other race american indian alaska native	n	6	6	4
other race multiple	n	3	1	3
other race native hawaiian pacific islander	n	1	0	0
white	n	25	29	30

Analyses this trial contributes to

Results

29 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	0.5 percent	0.24		45	not stated; modified itt; registry:outcomes
26	A2	change	-0.5 percent	0.22		50	not stated; modified itt; registry:outcomes
26	A2 vs A1	md	-1.0 percent		-1.7 to -0.4		not stated; modified itt; registry:outcomes
26	A3	change	-1.0 percent	0.22		50	not stated; modified itt; registry:outcomes
26	A3 vs A1	md	-1.5 percent		-2.2 to -0.9		not stated; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (3 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	1.96	51	not stated; safety; registry:outcomes
A2	events	3.92	51	not stated; safety; registry:outcomes
A3	events	3.85	52	not stated; safety; registry:outcomes

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	3 / 51	not stated; safety; registry:adverse_events
A2	events	1 / 51	not stated; safety; registry:adverse_events
A3	events	1 / 52	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 51	not stated; randomized; registry:flow
A2	events	0 / 51	not stated; randomized; registry:flow
A3	events	1 / 52	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 51	not stated; safety; registry:adverse_events
A2	events	7 / 51	not stated; safety; registry:adverse_events
A3	events	8 / 52	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 51	not stated; safety; registry:adverse_events
A2	events	9 / 51	not stated; safety; registry:adverse_events
A3	events	7 / 52	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	7 / 51	not stated; safety; registry:adverse_events
A2	events	8 / 51	not stated; safety; registry:adverse_events
A3	events	11 / 52	not stated; safety; registry:adverse_events

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; registry:outcomes
A2	events	0 / 51	not stated; safety; registry:outcomes
A3	events	0 / 52	not stated; safety; registry:outcomes

Suicidal ideation or behavior (3 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 51	not stated; safety; Suicide attempt; registry:adverse_events
A2	events	0 / 51	not stated; safety; Suicide attempt; registry:adverse_events
A3	events	0 / 52	not stated; safety; Suicide attempt; registry:adverse_events