parallel randomized trial

NCT02420262

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02420262S001760

Design

Randomized: 506
Start year: 2015
Treatment: 26 weeks, follow-up 27 weeks
Countries: multinational (89 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 18 or older; HbA1c 7.0 to 10.0; BMI up to 40; 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: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	metformin; prior glargine stopped; lifestyle: not reported	252	244	238
A2	Basal bolus insulin Insulin glargine U100 plus insulin aspart (basal bolus)	metformin at pretrial dose; lifestyle: not reported	254	245	233

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	Basal bolus insulin A2	Whole trial ALL
age	mean (years)	58.6	58.0
age	sd (years)	9.0	8.6
female	n	142	137
hba1c	mean (percent)	8.21	8.24
hba1c	sd (percent)	0.76	0.81
insulin dose	mean (U per day)			33
weight	mean (kg)	87.2	88.2
weight	sd (kg)	16.0	17.2

Analyses this trial contributes to

Results

25 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	-1.48 percent	0.05		244	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.02 percent		-0.16 to 0.12		not stated; full analysis; registry:outcomes
26	A2	change	-1.46 percent	0.05		245	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.93 kg	0.22		244	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-3.57 kg		-4.19 to -2.95		not stated; full analysis; registry:outcomes
26	A2	change	2.64 kg	0.22		246	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders				157 / 238	not stated; full analysis; registry:outcomes
26	A2	responders				156 / 233	not stated; 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				1 / 252	while on treatment; safety; registry:adverse_events
	A2	events				0 / 253	while on treatment; safety; registry:adverse_events

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

Arm	Statistic	Estimate	95% CI	Detail
A1	rate			not stated; safety; registry:outcomes
A1 vs A2	rate ratio	0.11	0.08 to 0.17	not stated; safety; registry:outcomes
A2	rate			not stated; safety; registry:outcomes

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 252	while on treatment; safety; cardiac failure; registry:adverse_events
	A2	events				0 / 253	while on treatment; 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				12 / 252	while on treatment; safety; registry:adverse_events
	A2	events				10 / 253	while on treatment; 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 / 252	not stated; randomized; registry:flow
	A2	events				0 / 254	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				28 / 252	while on treatment; safety; registry:adverse_events
	A2	events				4 / 253	while on treatment; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 252	while on treatment; safety; registry:adverse_events
	A2	events				10 / 253	while on treatment; safety; registry:adverse_events

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 252	while on treatment; safety; diabetic retinopathy; registry:adverse_events
	A2	events				14 / 253	while on treatment; safety; diabetic retinopathy; registry:adverse_events