parallel randomized trial

AWARD-9

A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine

Type 2 diabetes (adults)NCT02152371S000446

Design

Randomized: 300
Start year: 2014
Treatment: 28 weeks
Countries: Czech Republic, Puerto Rico, Hungary, United States, Italy, United Kingdom, Spain
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults with T2D on basal insulin glargine with or without metformin

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: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg + insulin glargine	titrated insulin glargine to fasting glucose below 5.6 mmol/L; metformin if already taken; lifestyle: not reported	150	150
A2	Placebo Placebo + insulin glargine	titrated insulin glargine to fasting glucose below 5.6 mmol/L; metformin if already taken; lifestyle: not reported	150	150

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	Placebo A2	Whole trial ALL
age	mean (years)	60.2	60.6
age	sd (years)	9.47	10.07
asian	n	0	1
black	n	5	6
diabetes duration	mean (years)			13.0
female	n	65	62
hba1c	mean (percent)			8.4
hispanic	n	26	25
insulin dose	mean (U/day)	40.71	36.59
insulin dose	sd (U/day)	23.12	21.46
metformin use	n	134	131
other race american indian alaska native	n	0	0
other race multiple	n	1	3
other race native hawaiian pacific islander	n	1	2
white	n	143	138

Analyses this trial contributes to

Results

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

HbA1c change (15 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1 vs A2	md	-0.77 percent		-0.97 to -0.56		not stated; modified itt; registry:outcomes
28	A1	change	-1.44 percent	0.09		150	not stated; modified itt; registry:outcomes
28	A1	change	-1.5 percent			95	hypothetical; randomized; age:<65; R0024573:Figure 2
28	A1	change	-1.3 percent			54	hypothetical; randomized; age:>=65; R0024573:Figure 2
28	A1	change	-1.4 percent			53	hypothetical; randomized; diabetes_duration:<10; R0024573:Figure 2
28	A1	change	-1.4 percent			96	hypothetical; randomized; diabetes_duration:>=10; R0024573:Figure 2
28	A1	change	-1.2 percent			115	hypothetical; randomized; hba1c:<=9; R0024573:Results
28	A1	change	-2.3 percent			34	hypothetical; randomized; hba1c:>9; R0024573:Results
28	A2	change	-0.67 percent	0.09		150	not stated; modified itt; registry:outcomes
28	A2	change	-0.7 percent			54	hypothetical; randomized; diabetes_duration:<10; R0024573:Figure 2
28	A2	change	-0.5 percent			121	hypothetical; randomized; hba1c:<=9; R0024573:Results
28	A2	change	-0.7 percent			92	hypothetical; randomized; age:<65; R0024573:Figure 2
28	A2	change	-0.6 percent			95	hypothetical; randomized; diabetes_duration:>=10; R0024573:Figure 2
28	A2	change	-0.6 percent			57	hypothetical; randomized; age:>=65; R0024573:Figure 2
28	A2	change	-1.1 percent			28	hypothetical; randomized; hba1c:>9; R0024573:Results

Body weight change in kilograms (diabetes) (15 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	-1.1 kg				not stated; randomized; age:<65; R0024573:Figure 3
28	A1	change	-1.91 kg	0.30		150	not stated; modified itt; registry:outcomes
28	A1 vs A2	md	-2.41 kg		-3.19 to -1.64		not stated; modified itt; registry:outcomes
28	A1	change	-1.6 kg				not stated; randomized; age:>=65; R0024573:Figure 3
28	A1	change	-1.3 kg				not stated; randomized; diabetes_duration:<10; R0024573:Figure 3
28	A1	change	-1.3 kg				not stated; randomized; diabetes_duration:>=10; R0024573:Figure 3
28	A1	change	-1.7 kg				not stated; randomized; hba1c:<=9; R0024573:Results
28	A1	change	-0.4 kg				not stated; randomized; hba1c:>9; R0024573:Results
28	A2	change	1.1 kg				not stated; randomized; diabetes_duration:<10; R0024573:Figure 3
28	A2	change	1.1 kg				not stated; randomized; age:>=65; R0024573:Figure 3
28	A2	change	1.0 kg				not stated; randomized; diabetes_duration:>=10; R0024573:Figure 3
28	A2	change	1.0 kg				not stated; randomized; age:<65; R0024573:Figure 3
28	A2	change	0.9 kg				not stated; randomized; hba1c:<=9; R0024573:Figure 3
28	A2	change	0.50 kg	0.30		150	not stated; modified itt; registry:outcomes
28	A2	change	1.3 kg				not stated; randomized; hba1c:>9; R0024573:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	responders	69.3			150	not stated; modified itt; registry:outcomes
28	A2	responders	35.3			150	not stated; modified itt; registry:outcomes

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

Arm	Statistic	Estimate	Events / N	Detail
A1	events		1 / 150	hypothetical; safety; R0024573:Results
A1	events	0.7	150	not stated; safety; registry:outcomes
A2	events	0.0	150	not stated; safety; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 150	not stated; safety; registry:adverse_events
	A2	events				7 / 150	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				6 / 150	not stated; randomized; registry:flow
	A2	events				2 / 150	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				18 / 150	not stated; safety; registry:adverse_events
	A2	events				2 / 150	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 150	not stated; safety; registry:adverse_events
	A2	events				0 / 150	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 150	not stated; safety; registry:adverse_events
	A2	events				6 / 150	not stated; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 150	not stated; safety; registry:outcomes
	A2	events				0 / 150	not stated; safety; registry:outcomes