parallel randomized trial

AWARD-10

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02597049S000305

Design

Randomized: 424
Start year: 2015
Treatment: 24 weeks
Countries
Sponsor: Eli Lilly and Company (industry)
Eligibility: T2D; HbA1c 7.0 to 9.5 percent; BMI 45 or lower; SGLT2i with or without metformin

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	SGLT2i with or without metformin; lifestyle: not reported	142	132
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	SGLT2i with or without metformin; lifestyle: not reported	142	134
A3	Placebo Placebo	SGLT2i with or without metformin; lifestyle: not reported	140	133

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	Dulaglutide 0.75 mg subcutaneous once weekly A2	Placebo A3
age	mean (years)	56.17	58.55	57.10
age	sd (years)	9.26	9.14	9.59
asian	n	0	1	0
bmi	mean (kg/m2)	32.87	32.77	32.39
bmi	sd (kg/m2)	5.56	6.27	4.98
diabetes duration	mean (years)	9.21	10.05	8.87
diabetes duration	sd (years)	5.74	6.56	6.13
egfr	mean (mL/min)	90.9		90.9
egfr	sd (mL/min)	18.8		16.9
female	n	65	72	74
female	percent	46	51	53
hba1c	mean (percent)	8.04	8.04	8.05
hba1c	sd (percent)	0.65	0.61	0.66
metformin use	n	133	135	135
metformin use	percent	94	96	96
sbp	mean (mmHg)	129.70	130.35	130.57
sbp	sd (mmHg)	14.48	15.66	13.74
weight	mean (kg)	92.87	91.07	90.50
weight	sd (kg)	19.73	20.99	19.47

Analyses this trial contributes to

Results

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

HbA1c change (10 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1 vs A3	md	-0.82 percent		-1.00 to -0.64		hypothetical; modified itt; registry:outcomes
24	A1	change	-1.34 percent	0.064		132	treatment policy; modified itt; registry:outcomes
24	A1 vs A3	md	-0.79 percent		-0.97 to -0.61		treatment policy; modified itt; registry:outcomes
24	A1	change	-1.33 percent	0.063		130	hypothetical; modified itt; registry:outcomes
24	A2	change	-1.21 percent	0.064		134	treatment policy; modified itt; registry:outcomes
24	A2	change	-1.19 percent	0.063		131	hypothetical; modified itt; registry:outcomes
24	A2 vs A3	md	-0.69 percent		-0.86 to -0.51		hypothetical; modified itt; registry:outcomes
24	A2 vs A3	md	-0.66 percent		-0.84 to -0.49		treatment policy; modified itt; registry:outcomes
24	A3	change	-0.54 percent	0.064		133	treatment policy; modified itt; registry:outcomes
24	A3	change	-0.51 percent	0.065		123	hypothetical; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (10 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-3.1 kg	0.30		142	treatment policy; modified itt; registry:outcomes
24	A1	change	-3.1 kg	0.30		142	hypothetical; modified itt; registry:outcomes
24	A1 vs A3	md	-0.8 kg		-1.7 to 0.0		hypothetical; modified itt; registry:outcomes
24	A1 vs A3	md	-0.9 kg		-1.8 to -0.1		treatment policy; modified itt; registry:outcomes
24	A2 vs A3	md	-0.3 kg		-1.2 to 0.5		hypothetical; modified itt; registry:outcomes
24	A2	change	-2.6 kg	0.30		141	hypothetical; modified itt; registry:outcomes
24	A2	change	-2.6 kg	0.30		141	treatment policy; modified itt; registry:outcomes
24	A2 vs A3	md	-0.5 kg		-1.3 to 0.4		treatment policy; modified itt; registry:outcomes
24	A3	change	-2.3 kg	0.31		140	hypothetical; modified itt; registry:outcomes
24	A3	change	-2.1 kg	0.30		140	treatment policy; modified itt; registry:outcomes

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	71.54	142	hypothetical; modified itt; registry:outcomes
24	A1	responders	71.21	142	treatment policy; modified itt; registry:outcomes
24	A2	responders	60.45	141	treatment policy; modified itt; registry:outcomes
24	A2	responders	61.83	141	hypothetical; modified itt; registry:outcomes
24	A3	responders	31.58	140	treatment policy; modified itt; registry:outcomes
24	A3	responders	32.52	140	hypothetical; modified itt; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 142	not stated; safety; R0020348:p1
A2	events	1 / 141	not stated; safety; R0020348:p1
A3	events	0 / 140	not stated; safety; R0020348:p1

Systolic blood pressure change (1 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1 vs A3	md	-3.3 mmHg		-6.1 to -0.4		not stated; modified itt; R0008191:Supplement Table S4

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	2 / 142	not stated; safety; R0020348:p1
A2	events	0 / 141	not stated; safety; R0020348:p1
A3	events	0 / 140	not stated; safety; R0020348:p1

Four point MACE including unstable angina (3 lines; O21B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 142	not stated; safety; registry:outcomes
A2	events	0 / 141	not stated; safety; registry:outcomes
A3	events	3 / 140	not stated; safety; registry:outcomes

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 142	not stated; safety; R0020348:p1
A2	events	3 / 141	not stated; safety; R0020348:p1
A3	events	5 / 140	not stated; safety; R0020348:p1

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 142	not stated; safety; R0020348:p1
A1	events	2 / 142	not stated; randomized; registry:flow
A2	events	0 / 141	not stated; safety; R0020348:p1
A2	events	0 / 142	not stated; randomized; registry:flow
A3	events	0 / 140	not stated; safety; R0020348:p1
A3	events	0 / 140	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	21 / 142	not stated; safety; R0020348:p1
A2	events	7 / 141	not stated; safety; R0020348:p1
A3	events	5 / 140	not stated; safety; R0020348:p1

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	8 / 142	not stated; safety; R0020348:p1
A2	events	14 / 141	not stated; safety; R0020348:p1
A3	events	4 / 140	not stated; safety; R0020348:p1

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 142	not stated; safety; R0020348:p1
A2	events	0 / 141	not stated; safety; R0020348:p1
A3	events	0 / 140	not stated; safety; R0020348:p1