parallel randomized trial

NCT01001104

Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes

Design

Randomized: 145
Start year: 2009
Treatment: 12 weeks, follow-up 16 weeks
Countries: Japan (15 sites)
Sponsor: Eli Lilly Japan (industry)
Eligibility: Japanese T2D age 20 to 74; BMI 18.5 to 40; HbA1c 7.0 to 9.5 percent after lead in

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	diet and exercise; lifestyle: not reported	37	37
A2	Dulaglutide 0.25 mg injection once weekly Dulaglutide 0.25 mg	diet and exercise; lifestyle: not reported	36	36
A3	Dulaglutide 0.5 mg injection once weekly Dulaglutide 0.5 mg	diet and exercise; lifestyle: not reported	37	37
A4	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	diet and exercise; lifestyle: not reported	35	35

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

Characteristic	Statistic	Placebo A1	Dulaglutide 0.25 mg injection once weekly A2	Dulaglutide 0.5 mg injection once weekly A3	Dulaglutide 0.75 mg subcutaneous once weekly A4
age	mean (years)	51.7	52.3	52.5	52.2
age	sd (years)	9.7	8.8	9.2	7.8
bmi	mean (kg/m2)	27.4	26.8	26.7	27.1
bmi	sd (kg/m2)	4.5	4.5	3.8	3.7
diabetes duration	mean (years)	4.7	4.3	4.9	4.6
diabetes duration	sd (years)	4.5	3.5	4.0	4.5
female	n	8	9	14	7
female	percent	21.6	25.0	37.8	20.0
hba1c	mean (percent)	8.0	8.1	8.0	8.0
hba1c	sd (percent)	0.6	0.7	0.7	0.6
other previous oad use	n	10	10	11	9
other previous oad use	percent	27.0	27.8	29.7	25.7
sbp	mean (mmHg)	127	128	128	128
sbp	sd (mmHg)	14	13	12	13
weight	mean (kg)	76.4	74.0	72.1	75.8
weight	sd (kg)	15.9	14.5	12.8	10.8

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	change	-0.18 percent	-0.36 to -0.01	36	hypothetical; full analysis; registry:outcomes
12	A2	change	-0.90 percent	-1.07 to -0.73	36	hypothetical; full analysis; registry:outcomes
12	A2 vs A1	md	-0.72 percent	-0.95 to -0.48		hypothetical; full analysis; R0015000:Results
12	A3	change	-1.15 percent	-1.32 to -0.98	37	hypothetical; full analysis; registry:outcomes
12	A3 vs A1	md	-0.97 percent	-1.20 to -0.73		hypothetical; full analysis; R0015000:Results
12	A4	change	-1.35 percent	-1.53 to -1.18	34	hypothetical; full analysis; registry:outcomes
12	A4 vs A1	md	-1.17 percent	-1.41 to -0.93		hypothetical; full analysis; R0015000:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.8 kg	0.3		37	hypothetical; full analysis; R0015000:Table 2
12	A1	change	-0.84 kg		-1.46 to -0.22	37	hypothetical; full analysis; registry:outcomes
12	A2	change	0.4 kg	0.3		36	hypothetical; full analysis; R0015000:Table 2
12	A2	change	0.41 kg		-0.20 to 1.03	36	hypothetical; full analysis; registry:outcomes
12	A2 vs A1	md	1.3 kg		0.4 to 2.1		hypothetical; full analysis; R0015000:Table 2
12	A3	change	-0.4 kg	0.3		37	hypothetical; full analysis; R0015000:Table 2
12	A3	change	-0.40 kg		-1.01 to 0.22	37	hypothetical; full analysis; registry:outcomes
12	A3 vs A1	md	0.5 kg		-0.4 to 1.3		hypothetical; full analysis; R0015000:Table 2
12	A4 vs A1	md	0.3 kg		-0.6 to 1.1		hypothetical; full analysis; R0015000:Table 2
12	A4	change	-0.6 kg	0.3		35	hypothetical; full analysis; R0015000:Table 2
12	A4	change	-0.58 kg		-1.21 to 0.05	35	hypothetical; full analysis; registry:outcomes

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Events / N	Detail
12	A1	responders	4 / 37	not stated; full analysis; R0015000:Table 2
12	A2	responders	17 / 36	not stated; full analysis; R0015000:Table 2
12	A3	responders	22 / 37	not stated; full analysis; R0015000:Table 2
12	A4	responders	27 / 35	not stated; full analysis; R0015000:Table 2

Level 2 or 3 hypoglycemia (participants) (8 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Table 3
A1	events	0 / 37	not stated; safety; R0015000:Results
A2	events	0 / 36	not stated; safety; R0015000:Results
A2	events	0 / 36	not stated; safety; R0015000:Table 3
A3	events	1 / 37	not stated; safety; R0015000:Table 3
A3	events	0 / 37	not stated; safety; R0015000:Results
A4	events	2 / 35	not stated; safety; R0015000:Table 3
A4	events	0 / 35	not stated; safety; R0015000:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Table 3
A2	events	1 / 36	not stated; safety; R0015000:Table 3
A3	events	0 / 37	not stated; safety; R0015000:Table 3
A4	events	1 / 35	not stated; safety; R0015000:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Table 3
A2	events	1 / 36	not stated; safety; R0015000:Table 3
A3	events	1 / 37	not stated; safety; R0015000:Table 3
A4	events	2 / 35	not stated; safety; R0015000:Table 3

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Table 3
A2	events	0 / 36	not stated; safety; R0015000:Table 3
A3	events	6 / 37	not stated; safety; R0015000:Table 3
A4	events	2 / 35	not stated; safety; R0015000:Table 3

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; registry:adverse_events
A2	events	0 / 36	not stated; safety; registry:adverse_events
A3	events	1 / 37	not stated; safety; registry:adverse_events
A4	events	0 / 35	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 37	not stated; safety; R0015000:Table 3
A2	events	1 / 36	not stated; safety; R0015000:Table 3
A3	events	1 / 37	not stated; safety; R0015000:Table 3
A4	events	1 / 35	not stated; safety; R0015000:Table 3

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Table 3
A2	events	0 / 36	not stated; safety; R0015000:Table 3
A3	events	0 / 37	not stated; safety; R0015000:Table 3
A4	events	3 / 35	not stated; safety; R0015000:Table 3

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Results
A2	events	0 / 36	not stated; safety; R0015000:Results
A3	events	0 / 37	not stated; safety; R0015000:Results
A4	events	0 / 35	not stated; safety; R0015000:Results

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; hyperplastic cholecystopathy; registry:adverse_events
A2	events	0 / 36	not stated; safety; hyperplastic cholecystopathy; registry:adverse_events
A3	events	0 / 37	not stated; safety; hyperplastic cholecystopathy; registry:adverse_events
A4	events	1 / 35	not stated; safety; hyperplastic cholecystopathy; registry:adverse_events

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0015000:Results
A2	events	0 / 36	not stated; safety; R0015000:Results
A3	events	0 / 37	not stated; safety; R0015000:Results
A4	events	0 / 35	not stated; safety; R0015000:Results

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; pancreatic carcinoma; R0015000:Results
A2	events	0 / 36	not stated; safety; pancreatic carcinoma; R0015000:Results
A3	events	0 / 37	not stated; safety; pancreatic carcinoma; R0015000:Results
A4	events	1 / 35	not stated; safety; pancreatic carcinoma; R0015000:Results