parallel randomized trial

DUAL™ II China

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD

Type 2 diabetes (adults)NCT03175120S001556

Design

Randomized: 453
Start year: 2017
Treatment: 26 weeks, follow-up 30 weeks
Countries: China (40 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or older; BMI 24 or higher; HbA1c 7.5 or higher; basal insulin 20 to 50 U plus metformin

Conduct and analysis

Blinding: double blind
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	Completed treatment
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	metformin; lifestyle: not reported	302	302
A2	Insulin degludec Insulin degludec	metformin; lifestyle: not reported	151	151

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
age	mean (years)	54.5	55.3
age	sd (years)	9.8	10.0
asian	n	302	151
black	n	0	0
bmi	mean (kg/m2)	27.5	27.0
bmi	sd (kg/m2)	3.3	2.9
diabetes duration	mean (years)	11.52	11.33
diabetes duration	sd (years)	5.9	6.3
female	n	119	60
female	percent	39.4	39.7
hba1c	mean (percent)	8.93	8.96
hba1c	sd (percent)	1.20	1.17
hispanic	n	0	0
insulin dose	mean (U/day)	25.3	24.5
insulin dose	sd (U/day)	6.2	5.7
other fpg	mean (mmol/L)	9.84	9.59
other fpg	sd (mmol/L)	2.8	2.8
other screening basal insulin: detemir	n	33	17
other screening basal insulin: detemir	percent	10.9	11.3
other screening basal insulin: glargine	n	218	111
other screening basal insulin: glargine	percent	72.2	73.5
other screening basal insulin: isophane	n	46	23
other screening basal insulin: isophane	percent	15.2	15.2
other screening basal insulin: zinc protamine	n	5	0
other screening basal insulin: zinc protamine	percent	1.7	0
other screening oad: metformin only	n	141	74
other screening oad: metformin only	percent	46.7	49.0
other screening oad: metformin plus alpha glucosidase inhibitor	n	89	44
other screening oad: metformin plus alpha glucosidase inhibitor	percent	29.5	29.1
other screening oad: metformin plus glinide	n	20	10
other screening oad: metformin plus glinide	percent	6.6	6.6
other screening oad: metformin plus sulfonylurea	n	44	22
other screening oad: metformin plus sulfonylurea	percent	14.6	14.6
other screening oad: metformin plus tzd	n	8	1
other screening oad: metformin plus tzd	percent	2.6	0.7
weight	mean (kg)	76.8	74.3
weight	sd (kg)	13.0	11.4
white	n	0	0

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.93 percent	1.14		289	not stated; full analysis; registry:outcomes
26	A1	change	-1.9 percent				not stated; full analysis; R0012135:Results
26	A1 vs A2	md	-0.92 percent		-1.09 to -0.75		not stated; full analysis; R0012135:Abstract
26	A1 vs A2	md	-0.88 percent		-1.06 to -0.71		not stated; completers; R0012135:Supplement Table 5
26	A1 vs A2	md	-0.92 percent		-1.09 to -0.75		not stated; full analysis; R0012135:Supplement Table 5
26	A1 vs A2	md	-0.88 percent		-1.06 to -0.71		not stated; full analysis; R0012135:Supplement Table 5
26	A1 vs A2	md	-0.91 percent		-1.08 to -0.73		not stated; per protocol; R0012135:Supplement Table 5
26	A2	change	-1.0 percent				not stated; full analysis; R0012135:Results
26	A2	change	-1.06 percent	1.19		138	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.7 kg				not stated; full analysis; R0012135:Results
26	A1	change	-0.7 kg	3.0		288	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-1.08 kg		-1.63 to -0.52		not stated; full analysis; R0012135:Abstract
26	A2	change	0.4 kg				not stated; full analysis; R0012135:Results
26	A2	change	0.5 kg	2.7		139	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders			151 / 289	not stated; full analysis; registry:outcomes
26	A1	responders	51.0		302	not stated; full analysis; R0012135:Figure 2
26	A1 vs A2	or	6.31	3.78 to 10.54		not stated; full analysis; R0012135:Figure 2
26	A2	responders	15.2		151	not stated; full analysis; R0012135:Figure 2
26	A2	responders			23 / 138	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	34 / 301	not stated; safety; R0012135:Supplement Table 6
A1	events	2 / 301	not stated; safety; R0012135:Supplement Table 6
A1	events	22 / 301	not stated; safety; R0012135:Supplement Table 6
A2	events	0 / 151	not stated; safety; R0012135:Supplement Table 6
A2	events	22 / 151	not stated; safety; R0012135:Supplement Table 6
A2	events	16 / 151	not stated; safety; R0012135:Supplement Table 6

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

Arm	Statistic	Estimate	95% CI	Detail
A1	rate			not stated; safety; R0012135:Supplement Table 6
A1 vs A2	rate ratio	0.53	0.30 to 0.94	not stated; safety; R0012135:Abstract
A2	rate			not stated; safety; R0012135:Supplement Table 6

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-3.5 mmHg				not stated; full analysis; R0012135:Supplement Table 8
26	A1	change	-3.5 mmHg	13.6		288	not stated; safety; registry:outcomes
26	A1 vs A2	md	-3.13 mmHg		-5.33 to -0.93		not stated; full analysis; R0012135:Supplement Table 8
26	A2	change	-0.1 mmHg				not stated; full analysis; R0012135:Supplement Table 8
26	A2	change	-0.5 mmHg	12.5		139	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 / 301	not stated; safety; registry:adverse_events
	A2	events				0 / 151	not stated; safety; registry:adverse_events

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 301	not stated; safety; R0012135:Table 3
	A2	events				2 / 151	not stated; safety; R0012135:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 301	not stated; safety; R0012135:Table 3
	A2	events				7 / 151	not stated; safety; R0012135:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 301	not stated; safety; R0012135:Results
A1	events	2 / 302	not stated; randomized; registry:flow
A2	events	2 / 151	not stated; safety; R0012135:Results
A2	events	2 / 151	not stated; randomized; registry:flow

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 301	not stated; safety; registry:adverse_events
	A2	events				0 / 151	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	22 / 301	not stated; safety; R0012135:Table 3
A1	events	1 / 301	not stated; safety; registry:adverse_events
A2	events	2 / 151	not stated; safety; R0012135:Table 3
A2	events	0 / 151	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 301	not stated; safety; registry:adverse_events
	A2	events				0 / 151	not stated; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 301	not stated; safety; R0012135:Results
	A2	events				0 / 151	not stated; safety; R0012135:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 301	not stated; safety; R0012135:Results
	A2	events				0 / 151	not stated; safety; R0012135:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 301	not stated; safety; R0012135:Results
	A2	events				0 / 151	not stated; safety; R0012135:Results

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				35 / 301	not stated; safety; diabetic retinopathy; R0012135:Table 3
	A2	events				11 / 151	not stated; safety; diabetic retinopathy; R0012135:Table 3

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 301	not stated; safety; R0012135:Results
	A2	events				0 / 151	not stated; safety; R0012135:Results

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 301	not stated; safety; R0012135:Results
	A2	events				0 / 151	not stated; safety; R0012135:Results