parallel randomized trial

LIRA-SWITCH™

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

Type 2 diabetes (adults)NCT01907854S001119

Design

Randomized: 407
Start year: 2013
Treatment: 26 weeks, follow-up 27 weeks
Countries: United States, Canada, Hungary, Israel, India, Spain (86 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 18 or more; HbA1c 7.5 to 9.5 percent; BMI 20 or more; on sitagliptin 100 mg and metformin for 90 days or more

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg (switch from sitagliptin)	metformin; sitagliptin placebo; lifestyle: not reported	203	202
A2	Sitagliptin Sitagliptin 100 mg continued	metformin; liraglutide placebo; lifestyle: not reported	204	204

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Sitagliptin A2
age	mean (years)	56.3	56.5
age	sd (years)	10.6	9.7
bmi	mean (kg/m2)	31.7	32.2
bmi	sd (kg/m2)	6.0	6.2
diabetes duration	mean (years)	7.9	7.6
diabetes duration	sd (years)	5.7	6.2
female	n	85	79
female	percent	42	39
hba1c	mean (percent)	8.3	8.2
hba1c	sd (percent)	0.6	0.6
sbp	mean (mmHg)	130.5	132.1
sbp	sd (mmHg)	14.4	12.1
waist	mean (cm)	106.9	106.9
waist	sd (cm)	14.8	14.4
weight	mean (kg)	88.9	91.2
weight	sd (kg)	19.8	19.6

Analyses this trial contributes to

Results

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-0.61 percent		-0.82 to -0.40		hypothetical; full analysis; R0025720:Results
26	A1	change	-1.14 percent				hypothetical; full analysis; R0025720:Results
26	A1	change	-1.146 percent	0.9748		176	not stated; full analysis; registry:outcomes
26	A2	change	-0.54 percent				hypothetical; full analysis; R0025720:Results
26	A2	change	-0.529 percent	1.0148		182	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	-3.31 kg				hypothetical; full analysis; R0025720:Results
26	A1 vs A2	md	-1.67 kg		-2.34 to -0.99		hypothetical; full analysis; R0025720:Results
26	A1	change	-3.32 kg	3.135		192	not stated; full analysis; registry:outcomes
26	A2	change	-1.80 kg	2.974		200	not stated; full analysis; registry:outcomes
26	A2	change	-1.64 kg				hypothetical; full analysis; R0025720:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	50.6		176	hypothetical; full analysis; R0025720:Results
26	A1 vs A2	or	3.36	2.08 to 5.42		hypothetical; full analysis; R0025720:Results
26	A2	responders	26.9		182	hypothetical; full analysis; R0025720:Results

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 202	not stated; safety; R0025720:Table 1
A1	events	0 / 202	not stated; safety; R0025720:Table 1
A2	events	0 / 204	not stated; safety; R0025720:Table 1
A2	events	3 / 204	not stated; safety; R0025720:Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	rate					not stated; safety; R0025720:Table 1

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-4.05 mmHg				hypothetical; full analysis; R0025720:Results
26	A1 vs A2	md	-1.87 mmHg		-4.28 to 0.53		hypothetical; full analysis; R0025720:Results
26	A1	change	-3.6 mmHg	11.596		192	not stated; full analysis; registry:outcomes
26	A2	change	-2.57 mmHg	11.593		200	not stated; full analysis; registry:outcomes
26	A2	change	-2.18 mmHg				hypothetical; full analysis; R0025720:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 202	not stated; safety; R0025720:Results
	A2	events				0 / 204	not stated; safety; R0025720:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 202	while on treatment; safety; cardiac failure congestive; registry:adverse_events
	A2	events				0 / 204	while on treatment; safety; cardiac failure congestive; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 202	not stated; safety; R0025720:Table 1
	A2	events				7 / 204	not stated; safety; R0025720:Table 1

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	6.4			202	not stated; safety; R0025720:Results
	A2	events	2.5			204	not stated; safety; R0025720:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				44 / 202	not stated; safety; R0025720:Table 1
	A2	events				16 / 204	not stated; safety; R0025720:Table 1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 202	not stated; safety; R0025720:Table 1
	A2	events				10 / 204	not stated; safety; R0025720:Table 1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				33 / 202	not stated; safety; R0025720:Table 1
	A2	events				19 / 204	not stated; safety; R0025720:Table 1

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 202	not stated; safety; R0025720:Results
	A2	events				0 / 204	not stated; safety; R0025720:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 202	not stated; safety; R0025720:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 202	not stated; safety; R0025720:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 202	not stated; safety; R0025720:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 202	not stated; safety; R0025720:Results

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 202	not stated; safety; R0025720:Results
	A2	events				2 / 204	not stated; safety; R0025720:Results