parallel randomized trial

AWARD-6

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)

Type 2 diabetes (adults)NCT01624259S001184

Design

Randomized: 599
Start year: 2012
Treatment: 26 weeks, follow-up 30 weeks
Countries: United States, Czech Republic, Hungary, Mexico, Slovakia, Puerto Rico, Poland, Spain, Romania, Germany
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults; HbA1c 7 to 10 percent; metformin 1500 mg/day or more

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg once weekly	metformin 1500 mg/day or more; lifestyle: not reported	299
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg once daily	metformin 1500 mg/day or more; lifestyle: not reported	300

Baseline characteristics

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

Characteristic	Statistic	Dulaglutide 1.5 mg subcutaneous once weekly A1	Liraglutide 1.8 mg subcutaneous once daily A2
age	mean (years)	56.49	56.81
age	sd (years)	9.34	9.91
asian	n	1	0
black	n	21	16
bmi	mean (kg/m2)	33.50	33.62
bmi	sd (kg/m2)	5.07	5.16
diabetes duration	mean (years)	7.13	7.28
diabetes duration	sd (years)	5.41	5.41
female	n	161	151
hba1c	mean (percent)	8.06	8.05
hba1c	sd (percent)	0.81	0.79
hispanic	n	75	72
other american indian alaska native	n	20	23
other multiple race	n	1	2
weight	mean (kg)	93.82	94.35
weight	sd (kg)	18.23	18.96
white	n	256	259

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-0.06 percent		-0.19 to 0.07		not stated; modified itt; registry:outcomes
26	A1	change	-1.42 percent			299	not stated; modified itt; R0022281:Table 3
26	A1	change	-1.42 percent	0.05		279	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-0.06 percent		-0.19 to 0.07		not stated; modified itt; registry:outcomes
26	A2	change	-1.36 percent			300	not stated; modified itt; R0022281:Table 3
26	A2	change	-1.36 percent	0.05		272	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (19 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	0.71 kg		0.17 to 1.26		hypothetical; modified itt; registry:outcomes
26	A1	change	-2.35 kg		-2.95 to -1.74		not stated; modified itt; sex:male; R0014882:Table 2
26	A1	change	-3.28 kg		-3.84 to -2.72		not stated; modified itt; sex:female; R0014882:Table 2
26	A1	change	-2.90 kg			299	not stated; modified itt; R0022281:Table 3
26	A1	change	-2.90 kg	0.22		299	hypothetical; modified itt; registry:outcomes
26	A1	change	-2.48 kg		-3.16 to -1.80		not stated; modified itt; diabetes_duration:<5; R0014882:Table 2
26	A1	change	-2.82 kg		-3.54 to -2.09		not stated; modified itt; hba1c:>=8.5; R0014882:Table 2
26	A1	change	-3.26 kg		-4.09 to -2.42		not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2
26	A1	change	-3.09 kg		-3.57 to -2.61		not stated; modified itt; hba1c:<8.5; R0014882:Table 2
26	A1	change	-3.00 kg		-3.64 to -2.35		not stated; modified itt; diabetes_duration:>=5<10; R0014882:Table 2
26	A2	change	-3.90 kg		-4.64 to -3.16		not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2
26	A2	change	-3.61 kg	0.22		299	hypothetical; modified itt; registry:outcomes
26	A2	change	-3.61 kg			300	not stated; modified itt; R0022281:Table 3
26	A2	change	-3.42 kg		-4.09 to -2.76		not stated; modified itt; diabetes_duration:<5; R0014882:Table 2
26	A2	change	-3.51 kg		-4.24 to -2.79		not stated; modified itt; diabetes_duration:>=5<10; R0014882:Table 2
26	A2	change	-4.07 kg		-4.56 to -3.58		not stated; modified itt; hba1c:<8.5; R0014882:Table 2
26	A2	change	-2.95 kg		-3.65 to -2.25		not stated; modified itt; hba1c:>=8.5; R0014882:Table 2
26	A2	change	-4.21 kg		-4.78 to -3.64		not stated; modified itt; sex:female; R0014882:Table 2
26	A2	change	-2.91 kg		-3.49 to -2.32		not stated; modified itt; sex:male; R0014882:Table 2

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	68.3		293	hypothetical; modified itt; registry:outcomes
26	A1 vs A2	or	1.02	0.64 to 1.63		hypothetical; modified itt; registry:outcomes
26	A1	responders	68.3		299	not stated; modified itt; R0022281:Table 3
26	A2	responders	67.9		300	not stated; modified itt; R0022281:Table 3
26	A2	responders	67.9		293	hypothetical; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	0.0	299	hypothetical; modified itt; registry:outcomes
A1	events	0	299	not stated; modified itt; R0022281:Table 3
A2	events	0.0	300	hypothetical; modified itt; registry:outcomes
A2	events	1.7	300	not stated; modified itt; R0022281:Table 3

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-3.36 mmHg	0.7		278	not stated; modified itt; registry:outcomes
26	A2	change	-2.82 mmHg	0.7		281	not stated; modified itt; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 299	not stated; safety; renal failure acute; registry:adverse_events
	A2	events				1 / 300	not stated; safety; renal failure acute; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 299	not stated; modified itt; registry:outcomes
	A2	events				0 / 300	not stated; modified itt; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 299	not stated; safety; registry:adverse_events
	A2	events				11 / 300	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				18 / 299	not stated; randomized; registry:flow
	A2	events				18 / 300	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				61 / 299	not stated; safety; registry:adverse_events
	A2	events				54 / 300	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				21 / 299	not stated; safety; registry:adverse_events
	A2	events				25 / 300	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				36 / 299	not stated; safety; registry:adverse_events
	A2	events				36 / 300	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 299	not stated; safety; registry:adverse_events
	A2	events				17 / 300	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 299	not stated; safety; cholelithiasis; registry:adverse_events
	A2	events				0 / 300	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 299	not stated; safety; registry:outcomes
	A2	events				0 / 300	not stated; safety; registry:outcomes

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 299	not stated; safety; papillary thyroid cancer; registry:adverse_events
	A2	events				1 / 300	not stated; safety; papillary thyroid cancer; registry:adverse_events