parallel randomized trial

NCT01584232

A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide

Type 2 diabetes (adults)NCT01584232S000246

Design

Randomized: 361
Start year: 2012
Treatment: 26 weeks, follow-up 30.29 weeks
Countries: Japan (35 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: Japanese adults 20 years or older; BMI 18.5 to less than 35 kg/m2; HbA1c 7.0 to 10.0 percent; on sulfonylurea and/or biguanide

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: hypothetical
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg once weekly	sulphonylurea and/or biguanide at stable pretrial dose; lifestyle: not reported	181	181
A2	Insulin glargine Insulin glargine once daily	sulphonylurea and/or biguanide at stable pretrial dose; lifestyle: not reported	180	180

Baseline characteristics

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

Characteristic	Statistic	Dulaglutide 0.75 mg subcutaneous once weekly A1	Insulin glargine A2
age: 65 or older	n	45	47
age: 65 or older	percent	25	26
age	mean (years)	57.5	56.1
age	sd (years)	10.5	11.3
asian	n	181	180
bmi	mean (kg/m2)	26.1	25.9
bmi	sd (kg/m2)	3.6	3.9
diabetes duration	mean (years)	8.9	8.8
diabetes duration	sd (years)	6.7	6.1
female	n	56	47
female	percent	31	26
hba1c	mean (percent)	8.1	8.0
hba1c	sd (percent)	0.8	0.9
other background: biguanide only	n	64	66
other background: biguanide only	percent	35	37
other background: su biguanide	n	83	81
other background: su biguanide	percent	46	45
other background: su only	n	34	33
other background: su only	percent	19	18
sbp	mean (mmHg)	129	129
sbp	sd (mmHg)	14	13
weight	mean (kg)	70.9	71.1
weight	sd (kg)	13.7	13.8

Analyses this trial contributes to

Results

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

HbA1c change (16 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.44 percent	0.05		178	hypothetical; full analysis; R0016159:Table 2
26	A1	change	-2.04 percent			44	not stated; other; hba1c:more_than_8.5; R0024141:p2
26	A1 vs A2	md	-0.54 percent		-0.67 to -0.41		hypothetical; full analysis; R0016159:Table 2
26	A1	change	-1.46 percent			56	not stated; full analysis; sex:female; R0022460:Table 3
26	A1	change	-1.37 percent			83	not stated; other; background:su_biguanide; R0024602:Results
26	A1	change	-1.43 percent			125	not stated; full analysis; sex:male; R0022460:Table 3
26	A1	change	-1.48 percent			34	not stated; other; background:su_only; R0024602:Results
26	A1	change	-1.48 percent			64	not stated; other; background:biguanide_only; R0024602:Results
26	A1	change	-1.27 percent			137	not stated; other; hba1c:8.5_or_less; R0024141:p2
26	A2	change	-0.90 percent	0.05		179	hypothetical; full analysis; R0016159:Table 2
26	A2	change	-1.02 percent			66	not stated; other; background:biguanide_only; R0024602:Results
26	A2	change	-0.78 percent			33	not stated; other; background:su_only; R0024602:Results
26	A2	change	-0.72 percent			138	not stated; other; hba1c:8.5_or_less; R0024141:p2
26	A2	change	-1.47 percent			42	not stated; other; hba1c:more_than_8.5; R0024141:p2
26	A2	change	-0.69 percent			47	not stated; full analysis; sex:female; R0022460:Table 3
26	A2	change	-0.98 percent			133	not stated; full analysis; sex:male; R0022460:Table 3

Body weight change in kilograms (diabetes) (11 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.48 kg	0.17		180	hypothetical; full analysis; R0016159:Table 2
26	A1 vs A2	md	-1.42 kg		-1.89 to -0.94		hypothetical; full analysis; R0016159:Table 2
26	A1	change	-0.21 kg			125	not stated; full analysis; sex:male; R0022460:Table 3
26	A1	change	-0.57 kg			137	not stated; other; hba1c:8.5_or_less; R0024141:p4
26	A1	change	-1.13 kg			56	not stated; full analysis; sex:female; R0022460:Table 3
26	A1	change	-0.20 kg			44	not stated; other; hba1c:more_than_8.5; R0024141:p4
26	A2	change	0.94 kg	0.17		180	hypothetical; full analysis; R0016159:Table 2
26	A2	change	0.80 kg			138	not stated; other; hba1c:8.5_or_less; R0024141:p4
26	A2	change	1.38 kg			42	not stated; other; hba1c:more_than_8.5; R0024141:p4
26	A2	change	0.53 kg			47	not stated; full analysis; sex:female; R0022460:Table 3
26	A2	change	1.07 kg			133	not stated; full analysis; sex:male; R0022460:Table 3

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders				127 / 178	hypothetical; full analysis; R0016159:Results
26	A2	responders				82 / 179	hypothetical; full analysis; R0016159:Results

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

Arm	Statistic	Events / N	Detail
A1	events	47 / 181	hypothetical; safety; R0016159:Results
A1	events	0 / 181	hypothetical; safety; R0016159:Results
A2	events	86 / 180	hypothetical; safety; R0016159:Results
A2	events	0 / 180	hypothetical; safety; R0016159:Results

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	0.4 mmHg	0.8		181	while on treatment; safety; R0016159:Table 3
26	A2	change	2.7 mmHg	0.8		180	while on treatment; safety; R0016159:Table 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 181	while on treatment; safety; R0016159:Table 3
	A2	events				0 / 180	while on treatment; safety; R0016159:Table 3

Three point MACE (6 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	1 / 181	while on treatment; safety; acute myocardial infarction; R0016159:Supplement Table S4
A1	events	2 / 181	while on treatment; safety; cerebral infarction; R0016159:Supplement Table S4
A1	events	1 / 181	not stated; safety; cerebellar infarction; registry:adverse_events
A2	events	0 / 180	while on treatment; safety; cerebral infarction; R0016159:Supplement Table S4
A2	events	0 / 180	not stated; safety; cerebellar infarction; registry:adverse_events
A2	events	0 / 180	while on treatment; safety; acute myocardial infarction; R0016159:Supplement Table S4

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 181	while on treatment; safety; R0016159:Table 3
	A2	events				3 / 180	while on treatment; safety; R0016159:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	6 / 181	while on treatment; randomized; R0016159:Results
A1	events	3 / 181	while on treatment; safety; R0016159:Table 3
A2	events	2 / 180	while on treatment; randomized; R0016159:Results
A2	events	1 / 180	while on treatment; safety; R0016159:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 181	while on treatment; safety; R0016159:Table 3
	A2	events				2 / 180	while on treatment; safety; R0016159:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 181	while on treatment; safety; R0016159:Table 3
	A2	events				2 / 180	while on treatment; safety; R0016159:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				22 / 181	while on treatment; safety; R0016159:Table 3
	A2	events				4 / 180	while on treatment; safety; R0016159:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 181	while on treatment; safety; R0016159:Table 3
	A2	events				6 / 180	while on treatment; safety; R0016159:Table 3

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 181	while on treatment; randomized; R0016159:Results
	A2	events				0 / 180	while on treatment; randomized; R0016159:Results

Gallbladder and biliary disease (8 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 181	while on treatment; safety; hyperplastic cholecystopathy; R0016159:Supplement Table S4
A1	events	1 / 181	not stated; safety; gallbladder polyp; registry:adverse_events
A1	events	1 / 181	while on treatment; safety; cholelithiasis; R0016159:Supplement Table S4
A1	events	0 / 181	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 180	while on treatment; safety; hyperplastic cholecystopathy; R0016159:Supplement Table S4
A2	events	0 / 180	while on treatment; safety; cholelithiasis; R0016159:Supplement Table S4
A2	events	1 / 180	not stated; safety; gallbladder polyp; registry:adverse_events
A2	events	1 / 180	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 / 181	while on treatment; safety; R0016159:Results
	A2	events				0 / 180	while on treatment; safety; R0016159:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 181	while on treatment; safety; R0016159:Results
	A2	events				0 / 180	while on treatment; safety; R0016159:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 181	while on treatment; safety; R0016159:Results
	A2	events				0 / 180	while on treatment; safety; R0016159:Results

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 181	not stated; safety; diabetic retinopathy; registry:adverse_events
	A2	events				2 / 180	not stated; safety; diabetic retinopathy; registry:adverse_events