parallel randomized trial

DUAL™ I China

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

Type 2 diabetes (adults)NCT03172494S000081

Design

Randomized: 720
Start year: 2017
Treatment: 26 weeks, follow-up 30 weeks
Countries: China (38 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: Chinese adults 18 y or older; HbA1c 7.0 to 10.0; BMI 40 or less; metformin with or without one OAD

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: full analysis
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	metformin; lifestyle: not reported	361	361
A2	Insulin degludec Insulin degludec	metformin; lifestyle: not reported	179	179
A3	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	metformin; lifestyle: not reported	180	180

Baseline characteristics

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

Characteristic	Statistic	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated A1	Insulin degludec A2	Liraglutide 1.8 mg subcutaneous once daily A3
age	mean (years)	54.5	55.7	54.1
age	sd (years)	10.3	10.2	10.2
bmi	mean (kg/m2)	27.0	26.5	26.5
bmi	sd (kg/m2)	3.9	3.6	3.6
diabetes duration	mean (years)	8.00	8.63	8.05
diabetes duration	sd (years)	5.33	5.55	5.28
female	n	142	79	72
female	percent	39.3	44.1	40.0
hba1c	mean (percent)	8.20	8.31	8.21
hba1c	sd (percent)	0.83	0.84	0.77
other metformin only	n	118	57	59
other metformin only	percent	32.7	31.8	32.8
weight	mean (kg)	74.8	73.2	73.8
weight	sd (kg)	14.3	13.2	13.3

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.71 percent	0.88		341	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-6.50 mmol/mol		-7.96 to -5.04		not stated; full analysis; R0012560:Results
26	A1 vs A2	md	-0.59 percent		-0.73 to -0.46		not stated; full analysis; registry:outcomes
26	A1 vs A3	md	-6.87 mmol/mol		-8.33 to -5.41		not stated; full analysis; R0012560:Results
26	A1 vs A3	md	-0.63 percent		-0.76 to -0.49		not stated; full analysis; registry:outcomes
26	A2	change	-1.20 percent	0.99		167	not stated; full analysis; registry:outcomes
26	A3	change	-1.16 percent	0.89		151	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (8 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	0.1 kg			361	not stated; full analysis; R0012560:Results
26	A1	change	0.2 kg	2.7		341	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-1.08 kg		-1.55 to -0.62		not stated; full analysis; R0012560:Results
26	A1 vs A3	md	2.57 kg		2.10 to 3.04		not stated; full analysis; R0012560:Results
26	A2	change	1.2 kg			179	not stated; full analysis; R0012560:Results
26	A2	change	1.3 kg	2.7		167	not stated; full analysis; registry:outcomes
26	A3	change	-2.4 kg			180	not stated; full analysis; R0012560:Results
26	A3	change	-2.5 kg	2.7		151	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	77.0	361	not stated; full analysis; R0012560:Results
26	A1	responders		272 / 341	not stated; full analysis; registry:outcomes
26	A2	responders	46.4	179	not stated; full analysis; R0012560:Results
26	A2	responders		83 / 167	not stated; full analysis; registry:outcomes
26	A3	responders	48.3	180	not stated; full analysis; R0012560:Results
26	A3	responders		80 / 151	not stated; full analysis; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	29 / 358	while on treatment; safety; R0012560:Table 2
A2	events	14 / 175	while on treatment; safety; R0012560:Table 2
A3	events	3 / 180	while on treatment; safety; R0012560:Table 2

Level 2 or 3 hypoglycemia (episode rate) (5 lines; O04B)

Arm	Statistic	Estimate	95% CI	Detail
A1	rate			while on treatment; safety; R0012560:Table 2
A1 vs A2	rate ratio	1.46	0.71 to 3.02	while on treatment; safety; R0012560:Results
A1 vs A3	rate ratio	6.36	1.83 to 22.15	while on treatment; safety; R0012560:Results
A2	rate			while on treatment; safety; R0012560:Table 2
A3	rate			while on treatment; safety; R0012560:Table 2

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-3.5 mmHg	12.7	341	not stated; safety; registry:outcomes
26	A2	change	-1.2 mmHg	11.7	167	not stated; safety; registry:outcomes
26	A3	change	-3.3 mmHg	13.8	151	not stated; safety; registry:outcomes

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 358	not stated; safety; R0012560:Results
A2	events	0 / 175	not stated; safety; R0012560:Results
A3	events	0 / 180	not stated; safety; R0012560:Results

Three point MACE (3 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	2 / 358	while on treatment; safety; R0012560:Results
A2	events	0 / 175	while on treatment; safety; R0012560:Results
A3	events	4 / 180	while on treatment; safety; R0012560:Results

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	14 / 358	while on treatment; safety; R0012560:Table 3
A2	events	7 / 175	while on treatment; safety; R0012560:Table 3
A3	events	14 / 180	while on treatment; safety; R0012560:Table 3

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	5 / 361	not stated; randomized; R0012560:Results
A2	events	1 / 179	not stated; randomized; R0012560:Results
A3	events	15 / 180	not stated; randomized; R0012560:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	14 / 358	while on treatment; safety; R0012560:Table 3
A2	events	1 / 175	while on treatment; safety; R0012560:Table 3
A3	events	21 / 180	while on treatment; safety; R0012560:Table 3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	23 / 358	while on treatment; safety; R0012560:Table 3
A2	events	3 / 175	while on treatment; safety; R0012560:Table 3
A3	events	26 / 180	while on treatment; safety; R0012560:Table 3

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 358	not stated; safety; R0012560:Results
A2	events	0 / 175	not stated; safety; R0012560:Results
A3	events	0 / 180	not stated; safety; R0012560:Results

Diabetic retinopathy complications (3 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	28 / 358	while on treatment; safety; diabetic retinopathy; R0012560:Table 3
A2	events	6 / 175	while on treatment; safety; diabetic retinopathy; R0012560:Table 3
A3	events	10 / 180	while on treatment; safety; diabetic retinopathy; R0012560:Table 3