parallel randomized trial

DUAL™ V

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)

Type 2 diabetes (adults)NCT01952145S001328

Design

Randomized: 557
Start year: 2013
Treatment: 26 weeks, follow-up 27 weeks
Countries: multinational
Sponsor: Novo Nordisk (industry)
Eligibility: T2D uncontrolled on insulin glargine 20 to 50 U plus metformin

Conduct and analysis

Blinding: open label
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 plus metformin	metformin; lifestyle: not reported	278	278
A2	Insulin glargine Insulin glargine U100 plus metformin	metformin; lifestyle: not reported	279	279

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 glargine A2
age	mean (years)	58.4	59.1
age	sd (years)	9.8	9.3
female	n	135	142
hba1c	mean (percent)	8.4	8.2
hba1c	sd (percent)	0.9	0.9
weight	mean (kg)	88.3	87.3
weight	sd (kg)	17.5	15.8

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.81 percent	1.08		278	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.59 percent		-0.74 to -0.45		not stated; full analysis; registry:outcomes
26	A2	change	-1.13 percent	0.98		279	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.4 kg	3.5		278	not stated; full analysis; registry:outcomes
26	A2	change	1.8 kg	3.6		279	not stated; full analysis; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 278	not stated; safety; registry:adverse_events
A1	events	79 / 278	not stated; safety; registry:outcomes
A2	events	137 / 279	not stated; safety; registry:outcomes
A2	events	1 / 279	not stated; safety; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 278	not stated; randomized; registry:flow
	A2	events				1 / 279	not stated; randomized; registry:flow

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 278	not stated; safety; cardiac failure; registry:adverse_events
	A2	events				1 / 279	not stated; safety; cardiac failure; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 278	not stated; safety; registry:adverse_events
	A2	events				9 / 279	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				9 / 278	not stated; randomized; registry:flow
	A2	events				0 / 279	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				26 / 278	not stated; safety; registry:adverse_events
	A2	events				3 / 279	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 278	not stated; safety; registry:adverse_events
	A2	events				5 / 279	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				20 / 278	not stated; safety; registry:adverse_events
	A2	events				7 / 279	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (6 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 278	not stated; safety; biliary colic; registry:adverse_events
A1	events	0 / 278	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	1 / 278	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 279	not stated; safety; biliary colic; registry:adverse_events
A2	events	1 / 279	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 279	not stated; safety; cholelithiasis; registry:adverse_events