crossover randomized trial

NCT03315780

A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus

Design

Randomized: 12
Start year: 2017
Treatment: 4 weeks, follow-up 14 weeks
Countries: Japan (1 sites)
Sponsor: Eli Lilly Japan K.K. (industry)
Eligibility: T2D 1 year or more; diet and exercise only; fasting glucose 120 to 200 mg/dL; weight 50 to 80 kg

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	diet and exercise; lifestyle: not reported	12	12
A2	Placebo Placebo	diet and exercise; lifestyle: not reported	12	12

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	58.9
age	sd (years)	7.1
asian	n	12
bmi	mean (kg/m2)	24.24
bmi	sd (kg/m2)	1.97
diabetes duration	mean (years)	8.5
diabetes duration	sd (years)	7.7
female	n	2
female	percent	16.7
hba1c	mean (percent)	7.9
hba1c	sd (percent)	1.2
weight	mean (kg)	64.74
weight	sd (kg)	8.5

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

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; registry:outcomes
A1	events	0 / 12	not stated; safety; registry:outcomes
A2	events	0 / 12	not stated; safety; registry:outcomes
A2	events	0 / 12	not stated; safety; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; registry:adverse_events
	A2	events				0 / 12	not stated; safety; registry:adverse_events

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; registry:adverse_events
	A2	events				0 / 12	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; registry:adverse_events
	A2	events				0 / 12	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				0 / 12	not stated; randomized; R0023615:Results
	A2	events				0 / 12	not stated; randomized; R0023615:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 12	not stated; randomized; R0023615:Table 2
	A2	events				0 / 12	not stated; randomized; R0023615:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 12	not stated; randomized; R0023615:Table 2
	A2	events				1 / 12	not stated; randomized; R0023615:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; randomized; R0023615:Results
	A2	events				0 / 12	not stated; randomized; R0023615:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; registry:adverse_events
	A2	events				0 / 12	not stated; safety; registry:adverse_events