parallel randomized trial

DUAL™ II

A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT01392573S002285

Design

Randomized: 413
Start year: 2011
Treatment: 26 weeks, follow-up 27 weeks
Countries
Sponsor: Novo Nordisk A/S (industry)
Eligibility: HbA1c 7.5 to 10 percent; BMI 27 or higher; basal insulin 20 to 40 U plus metformin with or without SU or glinides

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
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; prior SU or glinides stopped; lifestyle: not reported	207	199
A2	Insulin degludec Insulin degludec, maximum 50 U	metformin; prior SU or glinides stopped; lifestyle: not reported	206	199

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)	56.8	57.5
age	sd (years)	8.9	10.5
bmi	mean (kg/m2)	33.6	33.8
bmi	sd (kg/m2)	6	6
diabetes duration	mean (years)	10	11
diabetes duration	sd (years)	6	7
female	n	87	93
hba1c	mean (percent)	8.7	8.8
hba1c	sd (percent)	0.7	0.7
other screening oad: metformin sulfonylurea	n	104	101
other screening oad: metformin sulfonylurea	percent	52	51
other screening oad: metformin	n	95	98
other screening oad: metformin	percent	48	49
weight	mean (kg)	95.4	93.5
weight	sd (kg)	19.4	20.0

Analyses this trial contributes to

Results

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

HbA1c change (15 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.90 percent	1.09		199	not stated; full analysis; registry:outcomes
26	A1	change	-2.1 percent	1.0		95	not stated; full analysis; background:metformin_only; R0013496:Table 1
26	A1 vs A2	md	-0.95 percent		-1.23 to -0.66		not stated; full analysis; background:metformin_only; R0013496:Table 1
26	A1	change	-1.7 percent	1.2		104	not stated; full analysis; background:metformin_su_or_glinide; R0013496:Table 1
26	A1 vs A2	md	-1.14 percent		-1.43 to -0.85		not stated; full analysis; background:metformin_su_or_glinide; R0013496:Table 1
26	A1	change	-2.10 percent	0.95		100	not stated; full analysis; background:no_prior_su; R0012793:Table 2
26	A1 vs A2	md	-0.94 percent		-1.23 to -0.66		not stated; full analysis; background:no_prior_su; R0012793:Table 2
26	A1	change	-1.70 percent	1.19		99	not stated; full analysis; background:prior_su; R0012793:Table 2
26	A1 vs A2	md	-1.13 percent		-1.41 to -0.84		not stated; full analysis; background:prior_su; R0012793:Table 2
26	A1 vs A2	md	-1.05 percent		-1.25 to -0.84		not stated; full analysis; registry:outcomes
26	A2	change	-1.2 percent	1.2		98	not stated; full analysis; background:metformin_only; R0013496:Table 1
26	A2	change	-1.16 percent	1.21		100	not stated; full analysis; background:no_prior_su; R0012793:Table 2
26	A2	change	-0.63 percent	1.09		99	not stated; full analysis; background:prior_su; R0012793:Table 2
26	A2	change	-0.6 percent	1.1		101	not stated; full analysis; background:metformin_su_or_glinide; R0013496:Table 1
26	A2	change	-0.89 percent	1.18		199	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	-2.7 kg	3.7		199	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-2.77 kg		-3.75 to -1.79		not stated; full analysis; background:prior_su; R0012793:Table 2
26	A1	change	-2.30 kg	3.75		100	not stated; full analysis; background:no_prior_su; R0012793:Table 2
26	A1 vs A2	md	-2.41 kg		-3.39 to -1.43		not stated; full analysis; background:no_prior_su; R0012793:Table 2
26	A1	change	-3.06 kg	3.59		99	not stated; full analysis; background:prior_su; R0012793:Table 2
26	A2	change	0.27 kg	3.96		100	not stated; full analysis; background:no_prior_su; R0012793:Table 2
26	A2	change	0.0 kg	3.4		199	not stated; full analysis; registry:outcomes
26	A2	change	-0.27 kg	2.64		99	not stated; full analysis; background:prior_su; R0012793:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	cuminc	15.1				not stated; full analysis; R0021084:Table 1
	A2	cuminc	16.1				not stated; full analysis; R0021084:Table 1

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 199	not stated; safety; renal failure acute; registry:adverse_events
	A2	events				0 / 199	not stated; safety; renal failure acute; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 199	not stated; safety; registry:adverse_events
	A2	events				11 / 199	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				1 / 207	not stated; randomized; registry:flow
	A2	events				3 / 206	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 199	not stated; safety; registry:adverse_events
	A2	events				7 / 199	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 199	not stated; safety; registry:adverse_events
	A2	events				7 / 199	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 199	not stated; safety; cholecystitis acute; registry:adverse_events
	A2	events				0 / 199	not stated; safety; cholecystitis acute; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 199	not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events
	A2	events				1 / 199	not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events