parallel randomized trial

AWARD-CHN1

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT01644500S001064

Design

Randomized: 737
Start year: 2012
Treatment: 26 weeks, follow-up 30.29 weeks
Countries: China, South Korea, Taiwan (48 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 or older; BMI 19 to 35 kg/m2; HbA1c 7.0 to 10.5 percent OAM naive or 6.5 to 10.0 percent on OAM monotherapy

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	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	none, prior OAMs washed out; lifestyle: not reported	244	239	222
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	none, prior OAMs washed out; lifestyle: not reported	248	239	224
A3	Glimepiride Glimepiride 1 to 3 mg/d	none, prior OAMs washed out; lifestyle: not reported	245	242	230

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	Glimepiride A3
age: 65 or older	n	26	31	18
age: 65 or older	percent	10.9	13.0	7.4
age	mean (years)	52.7	53.8	52.0
age	sd (years)	10.75	10.09	10.05
asian	n	239	239	242
black	n	0	0	0
bmi	mean (kg/m2)	25.8	26.2	25.7
bmi	sd (kg/m2)	3.43	3.49	3.14
diabetes duration	mean (years)	4.0	3.5	3.8
diabetes duration	sd (years)	4.44	4.06	4.09
female	n	105	112	112
female	percent	43.9	46.9	46.3
hba1c: 8.5 or more	n	68	74	63
hba1c: 8.5 or more	percent	28.5	31.0	26.0
hba1c: less than 8.5	n	171	165	179
hba1c: less than 8.5	percent	71.5	69.0	74.0
hba1c	mean (percent)	8.0	8.0	7.9
hba1c	sd (percent)	0.95	1.03	1.01
other race american indian alaska native	n	0	0	0
other race multiple	n	0	0	0
other race native hawaiian pacific islander	n	0	0	0
sbp	mean (mmHg)	128	128	126
sbp	sd (mmHg)	13.3	13.7	14.7
weight	mean (kg)	69.7	70.7	69.1
weight	sd (kg)	10.8	12.0	10.6
white	n	0	0	0

Analyses this trial contributes to

Results

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

HbA1c change (36 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A3	md	-0.58 percent		-0.76 to -0.39		not stated; modified itt; R0014229:Results
26	A1	change	-1.48 percent	0.07		239	not stated; modified itt; R0014229:Results
26	A1	change	-1.97 percent				not stated; other; background:no_prior_oam; R0014229:Supplement Figure S2
26	A1 vs A3	md	-0.62 percent		-0.87 to -0.37		not stated; other; background:no_prior_oam; R0014229:Supplement Figure S2
26	A1	change	-1.06 percent				not stated; other; background:prior_oam; R0014229:Supplement Figure S2
26	A1 vs A3	md	-0.56 percent		-0.80 to -0.31		not stated; other; background:prior_oam; R0014229:Supplement Figure S2
26	A1	change	-1.45 percent		-1.69 to -1.21		not stated; modified itt; region:china_age_60_or_older; R0023562:Results
26	A1	change	-1.43 percent		-1.59 to -1.28		not stated; modified itt; region:china_age_less_than_60; R0023562:Results
26	A1	change	-2.2 percent			55	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 1
26	A1	change	-1.2 percent			129	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 1
26	A1	change	-2.02 percent	0.09			not stated; modified itt; region:china_no_prior_oam; R0019548:Results
26	A1 vs A3	md	-0.65 percent		-0.91 to -0.39		not stated; modified itt; region:china_no_prior_oam; R0019548:Results
26	A1	change	-1.46 percent	0.08			not stated; modified itt; region:china; R0023259:Results
26	A1 vs A3	md	-0.53 percent		-0.74 to -0.32		not stated; modified itt; region:china; R0023259:Abstract
26	A2	change	-0.75 percent				not stated; other; background:prior_oam; R0014229:Supplement Figure S2
26	A2 vs A3	md	-0.32 percent		-0.53 to -0.12		not stated; modified itt; region:china; R0023259:Abstract
26	A2	change	-1.22 percent	0.07		239	not stated; modified itt; R0014229:Results
26	A2 vs A3	md	-0.32 percent		-0.50 to -0.13		not stated; modified itt; R0014229:Results
26	A2	change	-0.9 percent			127	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 1
26	A2	change	-1.76 percent				not stated; other; background:no_prior_oam; R0014229:Supplement Figure S2
26	A2 vs A3	md	-0.41 percent		-0.65 to -0.16		not stated; other; background:no_prior_oam; R0014229:Supplement Figure S2
26	A2	change	-1.25 percent	0.08			not stated; modified itt; region:china; R0023259:Results
26	A2 vs A3	md	-0.25 percent		-0.49 to -0.01		not stated; other; background:prior_oam; R0014229:Supplement Figure S2
26	A2	change	-1.84 percent	0.09			not stated; modified itt; region:china_no_prior_oam; R0019548:Results
26	A2	change	-1.29 percent		-1.53 to -1.05		not stated; modified itt; region:china_age_60_or_older; R0023562:Results
26	A2 vs A3	md	-0.47 percent		-0.73 to -0.21		not stated; modified itt; region:china_no_prior_oam; R0019548:Results
26	A2	change	-1.18 percent		-1.33 to -1.03		not stated; modified itt; region:china_age_less_than_60; R0023562:Results
26	A2	change	-2.0 percent			59	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 1
26	A3	change	-0.50 percent				not stated; other; background:prior_oam; R0014229:Supplement Figure S2
26	A3	change	-0.92 percent	0.08			not stated; modified itt; region:china; R0023259:Results
26	A3	change	-0.7 percent			134	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 1
26	A3	change	-1.35 percent				not stated; other; background:no_prior_oam; R0014229:Supplement Figure S2
26	A3	change	-0.90 percent	0.07			not stated; modified itt; R0014229:Results
26	A3	change	-1.37 percent	0.09			not stated; modified itt; region:china_no_prior_oam; R0019548:Results
26	A3	change	-0.92 percent	0.069		242	not stated; modified itt; registry:outcomes
26	A3	change	-1.4 percent			52	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 1

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-1.85 kg			not stated; other; region:china_hba1c_less_than_8.5; R0022828:Figure 4
26	A1	change	-1.46 kg	0.192	222	not stated; modified itt; R0014229:Results
26	A1	change	-2.3 kg			not stated; modified itt; region:china_age_60_or_older; R0023562:Figure 1D
26	A1	change	-1.15 kg			not stated; modified itt; region:china_age_less_than_60; R0023562:Figure 1D
26	A1	change	-0.86 kg			not stated; other; region:china_hba1c_8.5_or_more; R0022828:Figure 4
26	A1	change	-1.40 kg	0.318		not stated; safety; region:china_no_prior_oam; R0019548:Results
26	A1	change	-1.5 kg	0.2		not stated; safety; region:china; R0023259:Results
26	A2	change	-0.92 kg			not stated; modified itt; region:china_age_60_or_older; R0023562:Figure 1D
26	A2	change	-0.96 kg	0.312		not stated; safety; region:china_no_prior_oam; R0019548:Results
26	A2	change	-0.77 kg	0.192	224	not stated; modified itt; R0014229:Results
26	A2	change	-0.94 kg			not stated; modified itt; region:china_age_less_than_60; R0023562:Figure 1D
26	A2	change	-1.0 kg	0.2		not stated; safety; region:china; R0023259:Results
26	A2	change	-1.28 kg			not stated; other; region:china_hba1c_less_than_8.5; R0022828:Figure 4
26	A2	change	-0.26 kg			not stated; other; region:china_hba1c_8.5_or_more; R0022828:Figure 4
26	A3	change	0.9 kg	0.2		not stated; safety; region:china; R0023259:Results
26	A3	change	1.63 kg			not stated; other; region:china_hba1c_8.5_or_more; R0022828:Figure 4
26	A3	change	0.60 kg			not stated; other; region:china_hba1c_less_than_8.5; R0022828:Figure 4
26	A3	change	0.73 kg	0.311		not stated; safety; region:china_no_prior_oam; R0019548:Results
26	A3	change	0.89 kg	0.190	231	not stated; modified itt; R0014229:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	74.1	239	not stated; modified itt; R0014229:Results
26	A2	responders	63.6	239	not stated; modified itt; R0014229:Figure 2C
26	A3	responders	57.4	242	not stated; modified itt; R0014229:Results

Level 2 or 3 hypoglycemia (participants) (18 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 244	not stated; safety; R0014229:Table 2
A1	events	6 / 244	not stated; safety; R0014229:Table 2
A1	events	2 / 244	not stated; safety; R0014229:Table 2
A1	events	14 / 244	not stated; safety; R0014229:Table 2
A1	events	1 / 244	not stated; safety; R0014229:Table 2
A1	events	7 / 244	not stated; safety; R0014229:Table 2
A2	events	3 / 248	not stated; safety; R0014229:Table 2
A2	events	2 / 248	not stated; safety; R0014229:Table 2
A2	events	1 / 248	not stated; safety; R0014229:Table 2
A2	events	4 / 248	not stated; safety; R0014229:Table 2
A2	events	0 / 248	not stated; safety; R0014229:Table 2
A2	events	9 / 248	not stated; safety; R0014229:Table 2
A3	events	12 / 243	not stated; safety; R0014229:Table 2
A3	events	0 / 243	not stated; safety; R0014229:Table 2
A3	events	26 / 243	not stated; safety; R0014229:Table 2
A3	events	15 / 243	not stated; safety; R0014229:Table 2
A3	events	38 / 243	not stated; safety; R0014229:Table 2
A3	events	5 / 243	not stated; safety; R0014229:Table 2

Level 2 or 3 hypoglycemia (episode rate) (24 lines; O04B)

Arm	Statistic	Estimate	Events / N	Detail
A1	rate	0.14	244	not stated; safety; R0014229:Table 2
A1	rate		244	not stated; safety; R0014229:Table 2
A1	rate		244	not stated; safety; R0014229:Table 2
A1	rate		244	not stated; safety; R0014229:Table 2
A1	rate	0.01	244	not stated; modified itt; registry:outcomes
A1	rate		244	not stated; safety; R0014229:Table 2
A1	rate	0.00	244	not stated; modified itt; registry:outcomes
A1	rate		244	not stated; safety; R0014229:Table 2
A2	rate	0.01	247	not stated; modified itt; registry:outcomes
A2	rate		248	not stated; safety; R0014229:Table 2
A2	rate	0.00	247	not stated; modified itt; registry:outcomes
A2	rate		248	not stated; safety; R0014229:Table 2
A2	rate		248	not stated; safety; R0014229:Table 2
A2	rate		248	not stated; safety; R0014229:Table 2
A2	rate		248	not stated; safety; R0014229:Table 2
A2	rate	0.09	248	not stated; safety; R0014229:Table 2
A3	rate		243	not stated; safety; R0014229:Table 2
A3	rate		243	not stated; safety; R0014229:Table 2
A3	rate		243	not stated; safety; R0014229:Table 2
A3	rate		243	not stated; safety; R0014229:Table 2
A3	rate	1.13	243	not stated; safety; R0014229:Table 2
A3	rate	0.09	243	not stated; modified itt; registry:outcomes
A3	rate		243	not stated; safety; R0014229:Table 2
A3	rate	0.01	243	not stated; modified itt; registry:outcomes

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-2.07 mmHg	0.815	222	not stated; modified itt; registry:outcomes
26	A2	change	-1.88 mmHg	0.813	224	not stated; modified itt; registry:outcomes
26	A3	change	-0.66 mmHg	0.804	231	not stated; modified itt; registry:outcomes

All cause mortality (9 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 244	not stated; randomized; R0014229:Figure 1
A1	events	0 / 244	while on treatment; safety; R0014229:Table 2
A1	events	0 / 189	while on treatment; safety; region:china; R0023259:Table 2
A2	events	1 / 248	while on treatment; safety; R0014229:Table 2
A2	events	1 / 194	while on treatment; safety; region:china; R0023259:Table 2
A2	events	1 / 248	not stated; randomized; R0014229:Figure 1
A3	events	0 / 243	while on treatment; safety; R0014229:Table 2
A3	events	0 / 245	not stated; randomized; R0014229:Figure 1
A3	events	0 / 187	while on treatment; safety; region:china; R0023259:Table 2

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 239	not stated; modified itt; registry:outcomes
	A3	events				0 / 242	not stated; modified itt; registry:outcomes

Four point MACE including unstable angina (2 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 239	not stated; modified itt; registry:outcomes
	A3	events				0 / 242	not stated; modified itt; registry:outcomes

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 239	not stated; modified itt; registry:outcomes
	A3	events				0 / 242	not stated; modified itt; registry:outcomes

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 239	not stated; modified itt; registry:outcomes
	A3	events				0 / 242	not stated; modified itt; registry:outcomes

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	final	85.72 points	9.723	234	not stated; modified itt; registry:outcomes
26	A2	final	86.17 points	10.744	230	not stated; modified itt; registry:outcomes
26	A3	final	85.96 points	10.938	237	not stated; modified itt; registry:outcomes

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	6 / 244	not stated; safety; R0014229:Table 2
A2	events	4 / 248	not stated; safety; R0014229:Table 2
A3	events	3 / 243	not stated; safety; R0014229:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	9 / 244	not stated; safety; R0014229:Table 2
A1	events	6 / 244	not stated; randomized; R0014229:Figure 1
A2	events	1 / 248	not stated; randomized; R0014229:Figure 1
A2	events	5 / 248	not stated; safety; R0014229:Table 2
A3	events	3 / 243	not stated; safety; R0014229:Table 2
A3	events	2 / 245	not stated; randomized; R0014229:Figure 1

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	25 / 244	not stated; safety; R0014229:Table 2
A2	events	13 / 248	not stated; safety; R0014229:Table 2
A3	events	1 / 243	not stated; safety; R0014229:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	19 / 244	not stated; safety; R0014229:Table 2
A2	events	4 / 248	not stated; safety; R0014229:Table 2
A3	events	1 / 243	not stated; safety; R0014229:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	42 / 244	not stated; safety; R0014229:Table 2
A2	events	18 / 248	not stated; safety; R0014229:Table 2
A3	events	7 / 243	not stated; safety; R0014229:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	8 / 244	not stated; safety; registry:adverse_events
A2	events	7 / 248	not stated; safety; registry:adverse_events
A3	events	0 / 243	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (9 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 244	not stated; safety; cholelithiasis; R0014229:Supplement Table S4
A1	events	1 / 244	not stated; safety; cholangitis; registry:adverse_events
A1	events	0 / 244	not stated; safety; cholecystitis infective; R0014229:Supplement Table S4
A2	events	1 / 248	not stated; safety; cholelithiasis; R0014229:Supplement Table S4
A2	events	1 / 248	not stated; safety; cholecystitis infective; R0014229:Supplement Table S4
A2	events	0 / 248	not stated; safety; cholangitis; registry:adverse_events
A3	events	0 / 243	not stated; safety; cholelithiasis; R0014229:Supplement Table S4
A3	events	0 / 243	not stated; safety; cholangitis; registry:adverse_events
A3	events	0 / 243	not stated; safety; cholecystitis infective; R0014229:Supplement Table S4

Acute pancreatitis (6 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	7 / 239	not stated; modified itt; registry:outcomes
A1	events	0 / 244	not stated; safety; R0014229:Results
A2	events	0 / 248	not stated; safety; R0014229:Results
A2	events	5 / 239	not stated; modified itt; registry:outcomes
A3	events	0 / 243	not stated; safety; R0014229:Results
A3	events	1 / 242	not stated; modified itt; registry:outcomes

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 244	not stated; safety; R0014229:Results
A2	events	0 / 248	not stated; safety; R0014229:Results
A3	events	0 / 243	not stated; safety; R0014229:Results

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 244	not stated; safety; R0014229:Results
A2	events	0 / 248	not stated; safety; R0014229:Results
A3	events	0 / 243	not stated; safety; R0014229:Results

Diabetic retinopathy complications (3 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	0 / 244	not stated; safety; diabetic retinopathy; registry:adverse_events
A2	events	0 / 248	not stated; safety; diabetic retinopathy; registry:adverse_events
A3	events	1 / 243	not stated; safety; diabetic retinopathy; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 244	while on treatment; safety; R0014229:Table 2
	A3	events				0 / 243	while on treatment; safety; R0014229:Table 2

Gastroparesis (3 lines; O37A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 244	not stated; safety; impaired gastric emptying; R0014229:Supplement Table S4
A2	events	0 / 248	not stated; safety; impaired gastric emptying; R0014229:Supplement Table S4
A3	events	0 / 243	not stated; safety; impaired gastric emptying; R0014229:Supplement Table S4