parallel randomized trial

NCT02288273

A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes

Type 2 diabetes (adults)NCT02288273S002087

Design

Randomized: 117
Start year: 2014
Treatment: 10 weeks, follow-up 14 weeks
Countries: USA (30 sites)
Sponsor: AstraZeneca (industry)
Eligibility: age 18 to 75; T2D on metformin 1500 mg or more; HbA1c 7.0 to 10.0 percent; BMI 45 or less

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
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 2.0 mg plus metformin	metformin extended release 1500 or 2000 mg; lifestyle: standard	61	60
A2	Placebo Placebo plus metformin	metformin extended release 1500 or 2000 mg; lifestyle: standard	56	56

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	mean (years)	55	56
age	sd (years)	11	10
asian	n	3	4
asian	percent	5.0	7.1
black	n	3	5
black	percent	5.0	8.9
bmi	mean (kg/m2)	32.0	31.6
bmi	sd (kg/m2)	6.2	5.4
diabetes duration	mean (years)	9	10
diabetes duration	sd (years)	6	8
hba1c	mean (percent)	8.2	8.0
hba1c	sd (percent)	1.1	0.9
hispanic	n	32	26
hispanic	percent	53.3	46.4
other male	n	33	32
other male	percent	55.0	57.1
other race native hawaiian pacific islander	n	1	0
other race native hawaiian pacific islander	percent	1.7	0.0
other race other	n	1	1
other race other	percent	1.7	1.8
weight	mean (kg)	90.5	90.0
weight	sd (kg)	19.3	19.1
white	n	52	46
white	percent	86.7	82.1

Analyses this trial contributes to

Results

22 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	Events / N	Detail
10	A1	change	-0.92 percent	0.10	60	not stated; modified itt; R0025397:Results
10	A1 vs A2	md	-0.73 percent	0.15		not stated; modified itt; R0025397:Results
10	A2	change	-0.20 percent	0.11	56	not stated; modified itt; R0025397:Results

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
10	A1	change	-1.1 kg	2.1			not stated; modified itt; R0025397:Results
10	A2	change	-0.5 kg	1.9			not stated; modified itt; R0025397:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 60	not stated; modified itt; R0025397:Results
	A2	events				0 / 56	not stated; modified itt; R0025397:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 60	not stated; modified itt; R0025397:Results
	A2	events				1 / 56	not stated; modified itt; R0025397:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 60	not stated; modified itt; R0025397:Results
	A2	events				2 / 56	not stated; modified itt; R0025397:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 60	not stated; modified itt; R0025397:Table 2
	A2	events				0 / 56	not stated; modified itt; R0025397:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 60	not stated; safety; registry:adverse_events
	A2	events				0 / 56	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 60	not stated; modified itt; R0025397:Table 2
	A2	events				2 / 56	not stated; modified itt; R0025397:Table 2

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 56	not stated; modified itt; R0025397:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 60	not stated; modified itt; R0025397:Results
	A2	events				0 / 56	not stated; safety; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 60	not stated; modified itt; R0025397:Results
	A2	events				0 / 56	not stated; modified itt; R0025397:Results