parallel randomized trial

NCT01554618

A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Children and adolescents with type 2 diabetes NCT01554618S000457

Design

Randomized: 83
Start year: 2016
Treatment: 52 weeks, follow-up 52 weeks
Countries: multinational (27 sites)
Sponsor: AstraZeneca (industry)
Eligibility: age 10 to below 18; HbA1c 6.5 to 11.0 (12.0 if insulin or sulfonylurea)

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly 2 mg	diet and exercise with or without metformin, sulfonylurea or insulin; lifestyle: not reported	59	58
A2	Placebo Placebo	diet and exercise with or without metformin, sulfonylurea or insulin; lifestyle: not reported	24	24

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Placebo A2
age	max (years)	17	17
age	mean (years)	15	16
age	min (years)	11	12
age	sd (years)	1.9	1.7
asian	n	2	1
asian	percent	3.4	4.2
black	n	17	8
black	percent	29.3	33.3
bmi	mean (kg/m2)	36.86	35.14
bmi	sd (kg/m2)	9.28	6.58
diabetes duration	mean (years)	2	3
diabetes duration	sd (years)	2	2
female	n	31	17
female	percent	53.4	70.8
hba1c	mean (percent)	8.1	8.3
hba1c	sd (percent)	1.2	1.5
hispanic	n	25	8
hispanic	percent	46.3	38.1
other background therapy: insulin and metformin	n	21	10
other background therapy: insulin and metformin	percent	36.2	41.7
other background therapy: insulin only	n	6	1
other background therapy: insulin only	percent	10.3	4.2
other background therapy: metformin and sulfonylurea	n	1	0
other background therapy: metformin and sulfonylurea	percent	1.7
other background therapy: metformin only	n	22	11
other background therapy: metformin only	percent	37.9	45.8
other background therapy: treatment naive	n	8	2
other background therapy: treatment naive	percent	13.8	8.3
other race american indian alaska native	n	4	1
other race american indian alaska native	percent	6.9	4.2
other race native hawaiian pacific islander	n	0	0
other race other	n	12	2
other race other	percent	20.7	8.3
weight	mean (kg)	102.2	96.7
weight	sd (kg)	30.1	22.7
white	n	23	12
white	percent	39.7	50.0

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.36 percent	0.184		58	hypothetical; modified itt; R0017380:Results
24	A1 vs A2	md	-0.85 percent		-1.51 to -0.19		hypothetical; modified itt; R0017380:Results
24	A2	change	0.49 percent	0.273		24	hypothetical; modified itt; R0017380:Results

Level 2 or 3 hypoglycemia (participants) (7 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	1 / 59	while on treatment; safety; R0017380:Results
A1	events	1 / 59	while on treatment; safety; R0017380:Table 2
A1	events	0 / 59	while on treatment; safety; R0017380:Table 2
A1	events	8 / 59	while on treatment; safety; R0017380:Table 2
A2	events	0 / 23	while on treatment; safety; R0017380:Table 2
A2	events	1 / 23	while on treatment; safety; R0017380:Table 2
A2	events	1 / 23	while on treatment; safety; R0017380:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 59	while on treatment; safety; R0017380:Table 2
	A2	events				1 / 23	while on treatment; safety; R0017380:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	0	59	while on treatment; safety; registry:outcomes
A1	events		1 / 59	not stated; randomized; registry:flow
A1	events	0	59	while on treatment; safety; registry:outcomes
A2	events		0 / 24	not stated; randomized; registry:flow
A2	events	0	23	while on treatment; safety; registry:outcomes
A2	events	0	23	while on treatment; safety; registry:outcomes

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 59	while on treatment; safety; R0017380:Table 2
	A2	events				1 / 23	while on treatment; safety; R0017380:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 59	while on treatment; safety; R0017380:Table 2
	A2	events				0 / 23	while on treatment; safety; R0017380:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 59	while on treatment; safety; R0017380:Table 2
	A2	events				1 / 23	while on treatment; safety; R0017380:Table 2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 59	not stated; randomized; R0017380:Results
	A2	events				0 / 24	not stated; randomized; registry:flow

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 59	while on treatment; safety; suicidal ideation; registry:adverse_events
	A2	events				0 / 23	while on treatment; safety; suicidal ideation; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 59	while on treatment; safety; R0017380:Table 2
	A2	events				0 / 23	while on treatment; safety; R0017380:Table 2