parallel randomized trial

AWARD-CHN2

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

Type 2 diabetes (adults)NCT01648582S001404

Design

Randomized: 774
Start year: 2012
Treatment: 52 weeks, follow-up 56 weeks
Countries: China, South Korea, Mexico, Russia (45 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 or older; BMI 19 to 35 kg/m2; HbA1c 7.0 to 11.0 percent on metformin and/or sulfonylurea

Conduct and analysis

Blinding: open label
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	metformin and/or sulfonylurea; lifestyle: not reported	258	253	226
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	metformin and/or sulfonylurea; lifestyle: not reported	257	252	219
A3	Insulin glargine Insulin glargine	metformin and/or sulfonylurea at stable prestudy dose; lifestyle: not reported	259	250	227

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	Insulin glargine A3
age	mean (years)	55.0	54.5	55.4
age	sd (years)	9.6	10.0	9.2
asian	n	213	209	209
black	n	0	0	0
bmi	mean (kg/m2)	26.6	27.0	26.7
bmi	sd (kg/m2)	3.7	3.8	3.5
diabetes duration	mean (years)	7.9	8.1	8.4
diabetes duration	sd (years)	4.8	5.3	5.3
female	n	118	109	111
female	percent	46.6	43.3	44.4
hba1c	mean (percent)	8.5	8.3	8.3
hba1c	sd (percent)	1.2	1.1	1.1
other background: metformin and sulfonylurea	percent	46.6	47.6	48.6
other background: metformin only	percent	41.9	40.0	40.2
other background: sulfonylurea only	percent	11.5	12.4	11.2
other race american indian alaska native	n	14	14	13
other race multiple	n	0	0	0
other race native hawaiian pacific islander	n	0	0	0
sbp	mean (mmHg)	130.79	129.36	131.42
sbp	sd (mmHg)	13.033	12.642	14.313
weight	mean (kg)	73.6	74.6	73.4
weight	sd (kg)	13.0	12.7	13.1
white	n	26	29	28

Analyses this trial contributes to

Results

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

HbA1c change (87 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.68 percent			91	not stated; other; region:east_asia_background_metformin_only; R0019120:Figure 1
26	A1	change	-1.67 percent	0.069			not stated; modified itt; region:china; R0023346:Results
26	A1 vs A3	md	-0.56 percent		-0.75 to -0.37		not stated; modified itt; region:china; R0023346:Results
26	A1	change	-1.64 percent			67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Figure 1
26	A1	change	-2.3 percent			80	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 1
26	A1	change	-1.63 percent			94	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Figure 1
26	A1	change	-1.70 percent			149	not stated; other; region:east_asia_age_less_than_60; R0019120:Figure 1
26	A1	change	-1.67 percent			64	not stated; other; region:east_asia_age_60_or_more; R0019120:Figure 1
26	A1	change	-1.73 percent	0.067		253	not stated; modified itt; R0023722:Results
26	A1	change	-1.69 percent			213	not stated; other; region:east_asia; R0019120:Figure 1
26	A1	change	-1.55 percent	0.12		88	not stated; other; region:east_asia_sex_female; R0019120:Results
26	A1	change	-1.73 percent			146	not stated; other; region:east_asia_duration_less_than_10; R0019120:Figure 1
26	A1	change	-1.60 percent		-1.83 to -1.36		not stated; modified itt; region:china_age_60_or_more; R0023562:Results
26	A1	change	-2.38 percent	0.12		88	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Results
26	A1	change	-1.82 percent	0.11		125	not stated; other; region:east_asia_sex_male; R0019120:Results
26	A1	change	-1.28 percent	0.11		125	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Results
26	A1	change	-1.77 percent			92	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Figure 1
26	A1	change	-1.64 percent			121	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Figure 1
26	A1 vs A3	md	-0.57 percent		-0.74 to -0.40		not stated; modified itt; R0023722:Results
26	A1	change	-1.2 percent			120	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 1
26	A1	change	-1.64 percent		-1.80 to -1.49		not stated; modified itt; region:china_age_less_than_60; R0023562:Results
26	A1	change	-1.71 percent			28	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Figure 1
26	A2	change	-1.45 percent			142	not stated; other; region:east_asia_duration_less_than_10; R0019120:Figure 1
26	A2	change	-1.76 percent	0.13		85	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Results
26	A2	change	-1.33 percent		-1.48 to -1.17		not stated; modified itt; region:china_age_less_than_60; R0023562:Results
26	A2	change	-1.04 percent	0.11		124	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Results
26	A2	change	-1.22 percent	0.12		83	not stated; other; region:east_asia_sex_female; R0019120:Results
26	A2	change	-1.7 percent			78	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 1
26	A2	change	-1.48 percent	0.11		126	not stated; other; region:east_asia_sex_male; R0019120:Results
26	A2	change	-1.0 percent			118	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 1
26	A2	change	-1.31 percent	0.069			not stated; modified itt; region:china; R0023346:Results
26	A2 vs A3	md	-0.20 percent		-0.39 to -0.01		not stated; modified itt; region:china; R0023346:Results
26	A2	change	-1.35 percent			59	not stated; other; region:east_asia_age_60_or_more; R0019120:Figure 1
26	A2	change	-1.37 percent			150	not stated; other; region:east_asia_age_less_than_60; R0019120:Figure 1
26	A2 vs A3	md	-0.18 percent		-0.35 to -0.01		not stated; modified itt; R0023722:Results
26	A2	change	-1.28 percent			93	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Figure 1
26	A2	change	-1.33 percent	0.067		252	not stated; modified itt; R0023722:Results
26	A2	change	-1.32 percent			88	not stated; other; region:east_asia_background_metformin_only; R0019120:Figure 1
26	A2	change	-1.58 percent			27	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Figure 1
26	A2	change	-1.29 percent			123	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Figure 1
26	A2	change	-1.37 percent			209	not stated; other; region:east_asia; R0019120:Figure 1
26	A2	change	-1.47 percent			86	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Figure 1
26	A2	change	-1.22 percent			67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Figure 1
26	A2	change	-1.31 percent		-1.55 to -1.08		not stated; modified itt; region:china_age_60_or_more; R0023562:Results
26	A3	change	-1.8 percent			80	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 1
26	A3	change	-1.7 percent			80	not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Results
26	A3	change	-0.7 percent			115	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 1
26	A3	change	-1.11 percent	0.070			not stated; modified itt; region:china; R0023346:Results
26	A3	change	-1.16 percent	0.067		250	not stated; modified itt; R0023722:Results
26	A3	change	-0.6 percent			115	not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Results
52	A1	change	-2.18 percent	0.133	-2.44 to -1.92	88	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Supplement Table 1
52	A1 vs A3	md	-0.57 percent		-0.77 to -0.38		not stated; modified itt; R0023722:Results
52	A1 vs A3	md	-0.59 percent		-0.80 to -0.38		not stated; modified itt; region:china; R0023346:Results
52	A1	change	-1.44 percent	0.118	-1.67 to -1.21	121	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Supplement Table 1
52	A1	change	-1.50 percent	0.144	-1.79 to -1.22	64	not stated; other; region:east_asia_age_60_or_more; R0019120:Supplement Table 1
52	A1	change	-1.38 percent	0.077			not stated; modified itt; region:china; R0023346:Results
52	A1	change	-1.50 percent	0.138	-1.77 to -1.22	67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Supplement Table 1
52	A1	change	-1.52 percent	0.113	-1.75 to -1.30	149	not stated; other; region:east_asia_age_less_than_60; R0019120:Supplement Table 1
52	A1	change	-1.65 percent	0.117	-1.88 to -1.42	125	not stated; other; region:east_asia_sex_male; R0019120:Supplement Table 1
52	A1	change	-1.54 percent	0.117	-1.77 to -1.31	146	not stated; other; region:east_asia_duration_less_than_10; R0019120:Supplement Table 1
52	A1	change	-1.62 percent	0.129	-1.87 to -1.37	92	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Supplement Table 1
52	A1	change	-1.53 percent	0.122	-1.77 to -1.29	94	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Supplement Table 1
52	A1	change	-1.35 percent	0.130	-1.61 to -1.09	88	not stated; other; region:east_asia_sex_female; R0019120:Supplement Table 1
52	A1	change	-1.37 percent	0.126	-1.62 to -1.12	91	not stated; other; region:east_asia_background_metformin_only; R0019120:Supplement Table 1
52	A1	change	-1.47 percent	0.076		253	not stated; modified itt; R0023722:Results
52	A1	change	-1.11 percent	0.124	-1.35 to -0.86	125	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Supplement Table 1
52	A1	change	-1.63 percent	0.202	-2.03 to -1.24	28	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Supplement Table 1
52	A2	change	-1.03 percent	0.076		252	not stated; modified itt; R0023722:Results
52	A2 vs A3	md	-0.13 percent		-0.33 to 0.06		not stated; modified itt; R0023722:Results
52	A2 vs A3	md	-0.13 percent		-0.33 to -0.06		not stated; modified itt; registry:outcomes
52	A2	change	-1.00 percent	0.078			not stated; modified itt; region:china; R0023346:Results
52	A2 vs A3	md	-0.21 percent		-0.43 to -0.00		not stated; modified itt; region:china; R0023346:Results
52	A2	change	-1.23 percent	0.151	-1.53 to -0.94	59	not stated; other; region:east_asia_age_60_or_more; R0019120:Supplement Table 1
52	A2	change	-1.16 percent	0.112	-1.38 to -0.94	150	not stated; other; region:east_asia_age_less_than_60; R0019120:Supplement Table 1
52	A2	change	-0.99 percent	0.123	-1.23 to -0.75	93	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Supplement Table 1
52	A2	change	-1.23 percent	0.127	-1.48 to -0.98	88	not stated; other; region:east_asia_background_metformin_only; R0019120:Supplement Table 1
52	A2	change	-1.36 percent	0.205	-1.76 to -0.95	27	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Supplement Table 1
52	A2	change	-1.11 percent	0.119	-1.34 to -0.88	123	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Supplement Table 1
52	A2	change	-1.28 percent	0.132	-1.54 to -1.02	86	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Supplement Table 1
52	A2	change	-1.05 percent	0.140	-1.33 to -0.77	67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Supplement Table 1
52	A2	change	-1.25 percent	0.117	-1.48 to -1.02	142	not stated; other; region:east_asia_duration_less_than_10; R0019120:Supplement Table 1
52	A2	change	-1.50 percent	0.136	-1.77 to -1.23	85	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Supplement Table 1
52	A2	change	-0.90 percent	0.124	-1.14 to -0.66	124	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Supplement Table 1
52	A2	change	-1.09 percent	0.131	-1.34 to -0.83	83	not stated; other; region:east_asia_sex_female; R0019120:Supplement Table 1
52	A2	change	-1.26 percent	0.119	-1.49 to -1.02	126	not stated; other; region:east_asia_sex_male; R0019120:Supplement Table 1
52	A3	change	-0.89 percent	0.075		250	not stated; modified itt; R0023722:Results
52	A3	change	-0.79 percent	0.078			not stated; modified itt; region:china; R0023346:Results

Body weight change in kilograms (diabetes) (76 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.28 kg				not stated; modified itt; region:china_age_less_than_60; R0023562:Figure 1D
26	A1	change	-1.47 kg	0.197		258	not stated; modified itt; R0023722:Results
26	A1	change	-0.97 kg	0.34		146	not stated; other; region:east_asia_duration_less_than_10; R0019120:Results
26	A1	change	-1.30 kg			213	not stated; other; region:east_asia; R0019120:Figure 3
26	A1	change	-1.15 kg				not stated; modified itt; region:china_age_60_or_more; R0023562:Figure 1D
26	A1	change	-0.53 kg				not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 4
26	A1	change	-1.78 kg				not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 4
26	A1	change	-1.30 kg	0.213			not stated; modified itt; region:china; R0023346:Results
26	A1	change	-0.96 kg			125	not stated; other; region:east_asia_sex_male; R0019120:Figure 3
26	A1	change	-1.29 kg			64	not stated; other; region:east_asia_age_60_or_more; R0019120:Figure 3
26	A1	change	-1.85 kg	0.40		67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Results
26	A1	change	-1.29 kg			149	not stated; other; region:east_asia_age_less_than_60; R0019120:Figure 3
26	A1	change	-1.77 kg			88	not stated; other; region:east_asia_sex_female; R0019120:Figure 3
26	A1	change	-1.37 kg			94	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Figure 3
26	A1	change	-1.40 kg			91	not stated; other; region:east_asia_background_metformin_only; R0019120:Figure 3
26	A1	change	-1.16 kg			92	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Figure 3
26	A1	change	-1.85 kg	0.35		125	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Results
26	A1	change	-1.00 kg			28	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Figure 3
26	A1	change	-0.63 kg	0.37		88	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Results
26	A1	change	-1.39 kg			121	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Figure 3
26	A2	change	-1.23 kg			67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Figure 3
26	A2	change	-1.03 kg			86	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Figure 3
26	A2	change	-1.19 kg			124	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Figure 3
26	A2	change	-1.35 kg			59	not stated; other; region:east_asia_age_60_or_more; R0019120:Figure 3
26	A2	change	-0.82 kg			85	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Figure 3
26	A2	change	-1.39 kg			83	not stated; other; region:east_asia_sex_female; R0019120:Figure 3
26	A2	change	-0.88 kg				not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 4
26	A2	change	-0.75 kg			93	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Figure 3
26	A2	change	-0.84 kg	0.214			not stated; modified itt; region:china; R0023346:Results
26	A2	change	-0.69 kg			126	not stated; other; region:east_asia_sex_male; R0019120:Figure 3
26	A2	change	-1.22 kg			88	not stated; other; region:east_asia_background_metformin_only; R0019120:Figure 3
26	A2	change	-0.99 kg			209	not stated; other; region:east_asia; R0019120:Figure 3
26	A2	change	-0.83 kg			150	not stated; other; region:east_asia_age_less_than_60; R0019120:Figure 3
26	A2	change	-0.80 kg			142	not stated; other; region:east_asia_duration_less_than_10; R0019120:Figure 3
26	A2	change	-1.31 kg				not stated; modified itt; region:china_age_60_or_more; R0023562:Figure 1D
26	A2	change	-0.88 kg	0.197		257	not stated; modified itt; R0023722:Results
26	A2	change	-0.64 kg				not stated; modified itt; region:china_age_less_than_60; R0023562:Figure 1D
26	A2	change	-1.31 kg			27	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Figure 3
26	A2	change	-0.79 kg				not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 4
26	A2	change	-0.95 kg			123	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Figure 3
26	A3	change	0.97 kg	0.197		253	not stated; modified itt; R0023722:Results
26	A3	change	1.36 kg				not stated; modified itt; region:china_hba1c_8.5_or_more; R0022828:Figure 4
26	A3	change	0.75 kg				not stated; modified itt; region:china_hba1c_less_than_8.5; R0022828:Figure 4
26	A3	change	1.00 kg	0.215			not stated; modified itt; region:china; R0023346:Results
52	A1	change	-1.04 kg	0.347	-1.72 to -0.35	94	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Supplement Table 3
52	A1	change	-1.08 kg	0.201		258	not stated; safety; registry:outcomes
52	A1	change	-0.82 kg	0.209			not stated; modified itt; region:china; R0023346:Results
52	A1	change	-0.84 kg	0.409	-1.65 to -0.04	64	not stated; other; region:east_asia_age_60_or_more; R0019120:Supplement Table 3
52	A1	change	-0.87 kg	0.319	-1.50 to -0.25	149	not stated; other; region:east_asia_age_less_than_60; R0019120:Supplement Table 3
52	A1	change	-0.98 kg	0.358	-1.68 to -0.28	91	not stated; other; region:east_asia_background_metformin_only; R0019120:Supplement Table 3
52	A1	change	-0.65 kg	0.578	-1.78 to 0.49	28	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Supplement Table 3
52	A1	change	-0.96 kg	0.341	-1.63 to -0.29	121	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Supplement Table 3
52	A1	change	-0.68 kg	0.386	-1.44 to 0.07	92	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Supplement Table 3
52	A1	change	-1.26 kg	0.395	-2.04 to -0.48	67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Supplement Table 3
52	A1	change	-0.63 kg	0.332	-1.28 to 0.02	146	not stated; other; region:east_asia_duration_less_than_10; R0019120:Supplement Table 3
52	A1	change	-0.47 kg	0.364	-1.19 to 0.24	88	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Supplement Table 3
52	A1	change	-1.19 kg	0.339	-1.85 to -0.52	125	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Supplement Table 3
52	A1	change	-1.28 kg	0.381	-2.02 to -0.53	88	not stated; other; region:east_asia_sex_female; R0019120:Supplement Table 3
52	A1	change	-0.56 kg	0.334	-1.22 to 0.09	125	not stated; other; region:east_asia_sex_male; R0019120:Supplement Table 3
52	A2	change	-0.59 kg	0.371	-1.32 to 0.13	85	not stated; other; region:east_asia_hba1c_8.5_or_more; R0019120:Supplement Table 3
52	A2	change	-0.76 kg	0.202		257	not stated; safety; registry:outcomes
52	A2	change	-0.84 kg	0.346	-1.52 to -0.16	123	not stated; other; region:east_asia_bmi_25_or_more; R0019120:Supplement Table 3
52	A2	change	-1.04 kg	0.362	-1.75 to -0.33	88	not stated; other; region:east_asia_background_metformin_only; R0019120:Supplement Table 3
52	A2	change	-0.48 kg	0.348	-1.17 to 0.20	93	not stated; other; region:east_asia_background_metformin_and_sulfonylurea; R0019120:Supplement Table 3
52	A2	change	-0.60 kg	0.330	-1.25 to 0.05	142	not stated; other; region:east_asia_duration_less_than_10; R0019120:Supplement Table 3
52	A2	change	-0.82 kg	0.338	-1.49 to -0.16	124	not stated; other; region:east_asia_hba1c_less_than_8.5; R0019120:Supplement Table 3
52	A2	change	-0.40 kg	0.315	-1.02 to 0.21	150	not stated; other; region:east_asia_age_less_than_60; R0019120:Supplement Table 3
52	A2	change	-1.45 kg	0.429	-2.29 to -0.61	59	not stated; other; region:east_asia_age_60_or_more; R0019120:Supplement Table 3
52	A2	change	-0.49 kg	0.390	-1.26 to 0.28	86	not stated; other; region:east_asia_bmi_less_than_25; R0019120:Supplement Table 3
52	A2	change	-1.17 kg	0.380	-1.92 to -0.43	83	not stated; other; region:east_asia_sex_female; R0019120:Supplement Table 3
52	A2	change	-1.09 kg	0.587	-2.24 to 0.07	27	not stated; other; region:east_asia_background_sulfonylurea_only; R0019120:Supplement Table 3
52	A2	change	-0.66 kg	0.212			not stated; modified itt; region:china; R0023346:Results
52	A2	change	-0.80 kg	0.401	-1.59 to -0.01	67	not stated; other; region:east_asia_duration_10_or_more; R0019120:Supplement Table 3
52	A2	change	-0.36 kg	0.339	-1.02 to 0.31	126	not stated; other; region:east_asia_sex_male; R0019120:Supplement Table 3
52	A3	change	1.34 kg	0.212			not stated; modified itt; region:china; R0023346:Results
52	A3	change	1.35 kg	0.201		253	not stated; safety; registry:outcomes

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	64.8	253	not stated; modified itt; R0023722:Results
26	A2	responders	52.8	252	not stated; modified itt; R0023722:Results
26	A3	responders	40.0	250	not stated; modified itt; R0023722:Results
52	A1	responders	51.8	253	not stated; modified itt; R0023722:Figure 2C
52	A2	responders	45.6	252	not stated; modified itt; R0023722:Figure 2C
52	A3	responders	32	250	not stated; modified itt; R0023722:Figure 2C

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 258	not stated; safety; R0023722:Table 2
A1	events	0 / 258	not stated; safety; R0023722:Table 2
A1	events	29 / 258	not stated; safety; R0023722:Supplement Table S6
A1	events	32 / 258	not stated; safety; R0023722:Supplement Table S7
A1	events	50 / 258	not stated; safety; R0023722:Table 2
A1	events	58 / 258	not stated; safety; R0023722:Table 2
A2	events	0 / 257	not stated; safety; R0023722:Table 2
A2	events	43 / 257	not stated; safety; R0023722:Table 2
A2	events	0 / 257	not stated; safety; R0023722:Table 2
A2	events	20 / 257	not stated; safety; R0023722:Supplement Table S6
A2	events	51 / 257	not stated; safety; R0023722:Table 2
A2	events	25 / 257	not stated; safety; R0023722:Supplement Table S7
A3	events	88 / 253	not stated; safety; R0023722:Table 2
A3	events	0 / 253	not stated; safety; R0023722:Table 2
A3	events	52 / 253	not stated; safety; R0023722:Supplement Table S7
A3	events	0 / 253	not stated; safety; R0023722:Table 2
A3	events	43 / 253	not stated; safety; R0023722:Supplement Table S6
A3	events	75 / 253	not stated; safety; R0023722:Table 2

Level 2 or 3 hypoglycemia (episode rate) (18 lines; O04B)

Arm	Statistic	Estimate	Events / N	Detail
A1	rate	1.27	258	not stated; safety; R0023722:Supplement Table S6
A1	rate	0.00	258	not stated; safety; R0023722:Supplement Table S7
A1	rate		258	not stated; safety; R0023722:Supplement Table S7
A1	rate	0.89	258	not stated; safety; R0023722:Supplement Table S7
A1	rate	0.00	258	not stated; safety; R0023722:Supplement Table S6
A1	rate		258	not stated; safety; R0023722:Supplement Table S6
A2	rate	0.00	257	not stated; safety; R0023722:Supplement Table S6
A2	rate	0.00	257	not stated; safety; R0023722:Supplement Table S7
A2	rate		257	not stated; safety; R0023722:Supplement Table S6
A2	rate		257	not stated; safety; R0023722:Supplement Table S7
A2	rate	0.98	257	not stated; safety; R0023722:Supplement Table S6
A2	rate	0.80	257	not stated; safety; R0023722:Supplement Table S7
A3	rate	0.00	253	not stated; safety; R0023722:Supplement Table S7
A3	rate	2.13	253	not stated; safety; R0023722:Supplement Table S6
A3	rate	0.00	253	not stated; safety; R0023722:Supplement Table S6
A3	rate	1.92	253	not stated; safety; R0023722:Supplement Table S7
A3	rate		253	not stated; safety; R0023722:Supplement Table S6
A3	rate		253	not stated; safety; R0023722:Supplement Table S7

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-5.53 mmHg	12.037	258	not stated; safety; R0023722:Table 2
26	A2	change	-2.77 mmHg	11.920	257	not stated; safety; R0023722:Table 2
26	A3	change	-2.22 mmHg	12.743	253	not stated; safety; R0023722:Table 2
52	A1	change	-2.18 mmHg	11.134	258	not stated; safety; R0023722:Table 2
52	A2	change	-0.61 mmHg	12.081	257	not stated; safety; R0023722:Table 2
52	A3	change	-0.25 mmHg	11.717	253	not stated; safety; R0023722:Table 2

All cause mortality (12 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	1 / 258	not stated; safety; R0023722:Table 2
A1	events	0 / 203	not stated; safety; region:china; R0023346:Table 2
A1	events	0 / 203	not stated; safety; region:china; R0023346:Table 2
A1	events	1 / 258	not stated; safety; R0023722:Table 2
A2	events	0 / 201	not stated; safety; region:china; R0023346:Table 2
A2	events	0 / 257	not stated; safety; R0023722:Table 2
A2	events	0 / 257	not stated; safety; R0023722:Table 2
A2	events	0 / 201	not stated; safety; region:china; R0023346:Table 2
A3	events	0 / 198	not stated; safety; region:china; R0023346:Table 2
A3	events	0 / 253	not stated; safety; R0023722:Table 2
A3	events	0 / 198	not stated; safety; region:china; R0023346:Table 2
A3	events	0 / 253	not stated; safety; R0023722:Table 2

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	1 / 258	not stated; safety; cardiac failure chronic; registry:adverse_events
A2	events	0 / 257	not stated; safety; cardiac failure chronic; registry:adverse_events
A3	events	0 / 253	not stated; safety; cardiac failure chronic; registry:adverse_events

Health related quality of life total score (any instrument) (6 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	1.08 points	12.644	258	not stated; modified itt; registry:outcomes
26	A2	change	1.67 points	13.456	257	not stated; modified itt; registry:outcomes
26	A3	change	1.41 points	10.885	253	not stated; modified itt; registry:outcomes
52	A1	change	2.65 points	12.029	258	not stated; modified itt; registry:outcomes
52	A2	change	2.34 points	14.003	257	not stated; modified itt; registry:outcomes
52	A3	change	2.55 points	12.257	253	not stated; modified itt; registry:outcomes

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	14 / 258	not stated; safety; R0023722:Table 2
A1	events	24 / 258	not stated; safety; R0023722:Table 2
A2	events	7 / 257	not stated; safety; R0023722:Table 2
A2	events	15 / 257	not stated; safety; R0023722:Table 2
A3	events	5 / 253	not stated; safety; R0023722:Table 2
A3	events	9 / 253	not stated; safety; R0023722:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	6 / 258	not stated; randomized; R0023722:Figure 1
A1	events	6 / 258	not stated; randomized; R0023722:Figure 1
A2	events	7 / 257	not stated; randomized; R0023722:Figure 1
A2	events	11 / 257	not stated; randomized; R0023722:Figure 1
A3	events	1 / 259	not stated; randomized; R0023722:Figure 1
A3	events	2 / 259	not stated; randomized; R0023722:Figure 1

Nausea (7 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	26 / 258	not stated; safety; R0023722:Table 2
A1	events	27 / 258	not stated; safety; registry:adverse_events
A1	events	26 / 258	not stated; safety; R0023722:Table 2
A2	events	14 / 257	not stated; safety; R0023722:Table 2
A2	events	14 / 257	not stated; safety; R0023722:Table 2
A3	events	2 / 253	not stated; safety; R0023722:Table 2
A3	events	2 / 253	not stated; safety; R0023722:Table 2

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	15 / 258	not stated; safety; R0023722:Table 2
A1	events	16 / 258	not stated; safety; R0023722:Table 2
A2	events	6 / 257	not stated; safety; R0023722:Table 2
A2	events	4 / 257	not stated; safety; R0023722:Table 2
A3	events	2 / 253	not stated; safety; R0023722:Table 2
A3	events	2 / 253	not stated; safety; R0023722:Table 2

Diarrhea (7 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	41 / 258	not stated; safety; R0023722:Table 2
A1	events	43 / 258	not stated; safety; registry:adverse_events
A1	events	42 / 258	not stated; safety; R0023722:Table 2
A2	events	24 / 257	not stated; safety; R0023722:Table 2
A2	events	28 / 257	not stated; safety; R0023722:Table 2
A3	events	6 / 253	not stated; safety; R0023722:Table 2
A3	events	7 / 253	not stated; safety; R0023722:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	9 / 258	not stated; safety; registry:adverse_events
A2	events	8 / 257	not stated; safety; registry:adverse_events
A3	events	0 / 253	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (21 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 258	not stated; safety; cholecystitis chronic; registry:adverse_events
A1	events	1 / 258	not stated; safety; gallbladder empyema; registry:adverse_events
A1	events	1 / 258	not stated; safety; post cholecystectomy syndrome; registry:adverse_events
A1	events	1 / 258	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	1 / 258	not stated; safety; cholecystitis; registry:adverse_events
A1	events	3 / 258	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	1 / 258	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 257	not stated; safety; cholecystitis chronic; registry:adverse_events
A2	events	0 / 257	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 257	not stated; safety; post cholecystectomy syndrome; registry:adverse_events
A2	events	1 / 257	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 257	not stated; safety; cholecystitis; registry:adverse_events
A2	events	0 / 257	not stated; safety; gallbladder empyema; registry:adverse_events
A2	events	0 / 257	not stated; safety; cholecystitis acute; registry:adverse_events
A3	events	0 / 253	not stated; safety; gallbladder empyema; registry:adverse_events
A3	events	0 / 253	not stated; safety; cholecystitis acute; registry:adverse_events
A3	events	0 / 253	not stated; safety; cholecystitis chronic; registry:adverse_events
A3	events	0 / 253	not stated; safety; cholecystitis; registry:adverse_events
A3	events	0 / 253	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 253	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 253	not stated; safety; post cholecystectomy syndrome; registry:adverse_events

Acute pancreatitis (9 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	1 / 258	not stated; safety; pancreatitis; registry:adverse_events
A1	events	0 / 258	not stated; safety; R0023722:Results
A1	events	2 / 258	not stated; safety; pancreatitis; registry:adverse_events
A2	events	0 / 257	not stated; safety; pancreatitis; registry:adverse_events
A2	events	0 / 257	not stated; safety; R0023722:Results
A2	events	0 / 257	not stated; safety; pancreatitis; registry:adverse_events
A3	events	0 / 253	not stated; safety; R0023722:Results
A3	events	0 / 253	not stated; safety; pancreatitis; registry:adverse_events
A3	events	0 / 253	not stated; safety; pancreatitis; registry:adverse_events

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 258	not stated; safety; papillary thyroid cancer; registry:adverse_events
A2	events	0 / 257	not stated; safety; papillary thyroid cancer; registry:adverse_events
A3	events	0 / 253	not stated; safety; papillary thyroid cancer; registry:adverse_events

Diabetic retinopathy complications (6 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	1 / 258	not stated; safety; diabetic retinopathy; registry:adverse_events
A1	events	0 / 258	not stated; safety; retinopathy; registry:adverse_events
A2	events	0 / 257	not stated; safety; diabetic retinopathy; registry:adverse_events
A2	events	0 / 257	not stated; safety; retinopathy; registry:adverse_events
A3	events	0 / 253	not stated; safety; diabetic retinopathy; registry:adverse_events
A3	events	2 / 253	not stated; safety; retinopathy; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 257	not stated; safety; R0023722:Table 2
	A3	events				0 / 253	not stated; safety; R0023722:Table 2

Gastroparesis (3 lines; O37A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 258	not stated; safety; impaired gastric emptying; registry:adverse_events
A2	events	1 / 257	not stated; safety; impaired gastric emptying; registry:adverse_events
A3	events	0 / 253	not stated; safety; impaired gastric emptying; registry:adverse_events

Intestinal obstruction or ileus (3 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 258	not stated; safety; gastrointestinal obstruction; registry:adverse_events
A2	events	0 / 257	not stated; safety; gastrointestinal obstruction; registry:adverse_events
A3	events	0 / 253	not stated; safety; gastrointestinal obstruction; registry:adverse_events

Pancreatic cancer (3 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 258	not stated; safety; R0023722:Results
A2	events	0 / 257	not stated; safety; R0023722:Results
A3	events	0 / 253	not stated; safety; R0023722:Results