parallel randomized trial

DUALTM IX

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i

Type 2 diabetes (adults)NCT02773368S001236

Design

Randomized: 420
Start year: 2016
Treatment: 26 weeks, follow-up 30 weeks
Countries: multinational (74 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: adults; insulin naive type 2 diabetes on SGLT2 inhibitor with or without other oral drugs; HbA1c 7.0 to 11.0 percent; BMI 20 to 40

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: reference based multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	SGLT2 inhibitor with or without metformin, DPP-4 inhibitor stopped, or pioglitazone; lifestyle: not reported	210	210
A2	Insulin glargine Insulin glargine U100	SGLT2 inhibitor with or without metformin, DPP-4 inhibitor stopped, or pioglitazone; lifestyle: not reported	210	210

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)	56.1	57.2
age	sd (years)	10.4	10.2
asian	percent	14.8	16.7
black	percent	1.4	1.0
bmi	mean (kg/m2)	31.5	30.9
bmi	sd (kg/m2)	4.8	4.8
diabetes duration	mean (years)	9.8	9.3
diabetes duration	sd (years)	6.2	6.3
hba1c	mean (percent)	8.2	8.4
hba1c	sd (percent)	0.9	1.1
other male	n	121	126
other male	percent	57.6	60.0
other race other	percent	0.5	1.0
weight	mean (kg)	89.3	87.2
weight	sd (kg)	17.6	17.2
white	percent	83.3	81.4

Analyses this trial contributes to

Results

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

HbA1c change (10 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-0.34 percent		-0.48 to -0.20		not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.36 percent		-0.50 to -0.21		treatment policy; full analysis; R0014323:Results
26	A1	change	-2.02 percent	1.00		145	treatment policy; full analysis; background:no_prior_dpp4i; R0012793:Table 3
26	A1 vs A2	md	-0.34 percent		-0.51 to -0.16		treatment policy; full analysis; background:no_prior_dpp4i; R0012793:Table 3
26	A1	change	-1.75 percent	0.79		65	treatment policy; full analysis; background:prior_dpp4i; R0012793:Table 3
26	A1 vs A2	md	-0.40 percent		-0.64 to -0.15		treatment policy; full analysis; background:prior_dpp4i; R0012793:Table 3
26	A1	change	-1.94 percent	0.95		210	treatment policy; full analysis; registry:outcomes
26	A2	change	-1.37 percent	0.70		71	treatment policy; full analysis; background:prior_dpp4i; R0012793:Table 3
26	A2	change	-1.68 percent	1.05		210	treatment policy; full analysis; registry:outcomes
26	A2	change	-1.84 percent	1.16		139	treatment policy; full analysis; background:no_prior_dpp4i; R0012793:Table 3

Body weight change in kilograms (diabetes) (9 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	0.00 kg	3.93		145	treatment policy; full analysis; background:no_prior_dpp4i; R0012793:Table 3
26	A1 vs A2	md	-1.92 kg		-2.64 to -1.19		treatment policy; full analysis; R0014323:Results
26	A1	change	-0.08 kg	3.52		65	treatment policy; full analysis; background:prior_dpp4i; R0012793:Table 3
26	A1	change	-0.0 kg	3.8		210	treatment policy; full analysis; registry:outcomes
26	A1 vs A2	md	-1.95 kg		-2.83 to -1.08		treatment policy; full analysis; background:no_prior_dpp4i; R0012793:Table 3
26	A1 vs A2	md	-1.84 kg		-3.11 to -0.56		treatment policy; full analysis; background:prior_dpp4i; R0012793:Table 3
26	A2	change	2.0 kg	3.9		210	treatment policy; full analysis; registry:outcomes
26	A2	change	2.07 kg	4.00		139	treatment policy; full analysis; background:no_prior_dpp4i; R0012793:Table 3
26	A2	change	1.85 kg	3.60		71	treatment policy; full analysis; background:prior_dpp4i; R0012793:Table 3

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders				167 / 210	treatment policy; full analysis; registry:outcomes
26	A2	responders				144 / 210	treatment policy; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	12.9			209	while on treatment; safety; R0014323:Results
	A2	events	19.5			210	while on treatment; safety; R0014323:Results

Level 2 or 3 hypoglycemia (episode rate) (1 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	rate ratio	0.42		0.23 to 0.75		not stated; safety; R0014323:Results

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-3.0 mmHg				treatment policy; full analysis; R0014323:Results
26	A1	change	-3.0 mmHg	12.7		210	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-2.87 mmHg		-5.01 to -0.74		treatment policy; full analysis; R0014323:Results
26	A2	change	0.6 mmHg	12.0		210	not stated; full analysis; registry:outcomes
26	A2	change	0.6 mmHg				treatment policy; full analysis; R0014323:Results

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 209	while on treatment; safety; R0014323:Table 3
	A2	events				1 / 210	while on treatment; safety; R0014323:Table 3

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 209	while on treatment; safety; R0014323:Table 3
A1	events	0 / 209	while on treatment; safety; registry:adverse_events
A2	events	1 / 210	while on treatment; safety; R0014323:Table 3
A2	events	0 / 210	while on treatment; safety; registry:adverse_events

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 209	while on treatment; safety; R0014323:Results
	A2	events				1 / 210	while on treatment; safety; R0014323:Results

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	final	points			210	not stated; full analysis; registry:outcomes
26	A2	final	points			210	not stated; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 209	while on treatment; safety; R0014323:Table 3
	A2	events				7 / 210	while on treatment; safety; R0014323:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 209	while on treatment; safety; R0014323:Results
	A2	events				1 / 210	while on treatment; safety; R0014323:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 209	while on treatment; safety; R0014323:Supplement Table S4
	A2	events				1 / 210	while on treatment; safety; R0014323:Supplement Table S4

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 209	while on treatment; safety; R0014323:Results
	A2	events				0 / 210	while on treatment; safety; R0014323:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 209	while on treatment; safety; R0014323:Results
	A2	events				0 / 210	while on treatment; safety; R0014323:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 209	while on treatment; safety; R0014323:Results
	A2	events				0 / 210	while on treatment; safety; R0014323:Results