parallel randomized trial

ELEGANT

The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial)

Design

Randomized: 50
Start year: 2012
Treatment: 26 weeks, follow-up 26 weeks
Countries: Netherlands (2 sites)
Sponsor: Radboud University Medical Center (industry)
Eligibility: age 18 to 75; BMI 25 or more; HbA1c 6.5 to 8.5 percent; insulin 3 to 16 months with 4 percent weight gain

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg added to insulin	insulin with or without metformin or sulfonylurea; lifestyle: none	26	26
A2	Standard care or no added treatment Standard therapy, continued and intensified insulin	insulin with or without metformin or sulfonylurea, adjusted by Wolverhampton based algorithm; lifestyle: none	24	24

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	Standard care or no added treatment A2	Whole trial ALL
age	mean (years)	57	59
age	sd (years)	10	8
asian	n			1
bmi	mean (kg/m2)	34	32
bmi	sd (kg/m2)	7	5
diabetes duration	mean (years)	8.3	7.6
diabetes duration	sd (years)	5.9	6.2
female	n	10	9
hba1c	mean (percent)	7.2	7.5
hba1c	sd (percent)	0.6	0.7
insulin dose	mean (U/kg/day)	0.51	0.50
insulin dose	sd (U/kg/day)	0.30	0.29
other background: basal bolus insulin	n	8	8
other background: basal bolus insulin	percent	30.8	33.3
other background: basal insulin only	n	14	13
other background: basal insulin only	percent	53.8	54.2
other background: biphasic insulin	n	4	2
other background: biphasic insulin	percent	15.4	8.3
other background: insulin pump	n	0	1
other background: insulin pump	percent		4.2
other background: metformin only	n	13	12
other background: metformin only	percent	50	50
other background: no oral agent	n	3	3
other background: no oral agent	percent	11.5	12.5
other background: sulfonylurea and metformin	n	8	7
other background: sulfonylurea and metformin	percent	30.8	29.2
other background: sulfonylurea only	n	2	2
other background: sulfonylurea only	percent	7.7	8.3
sbp	mean (mmHg)	137	141
sbp	sd (mmHg)	16	15
waist	mean (cm)	110	107
waist	sd (cm)	13	15
weight	mean (kg)	102.3	97.7
weight	sd (kg)	20.1	18.5

35 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	-0.77 percent	0.11		26	not stated; randomized; R0025175:Results
26	A1 vs A2	md	-0.74 percent		-1.08 to -0.41		not stated; randomized; R0025175:Results
26	A2	change	0.01 percent	0.12		24	not stated; randomized; R0025175:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-4.5 kg	0.5		26	not stated; randomized; R0025175:Results
26	A1 vs A2	md	-5.2 kg		-6.7 to -3.6		not stated; randomized; R0025175:Results
26	A2	change	0.9 kg	0.6		24	not stated; randomized; R0025175:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders				19 / 26	not stated; randomized; R0025175:Results
26	A2	responders				7 / 24	not stated; randomized; R0025175:Results

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

Arm	Statistic	Events / N	Detail
A1	events	15 / 26	not stated; randomized; R0025175:Table 3
A1	events	0 / 26	not stated; randomized; R0025175:Results
A2	events	8 / 24	not stated; randomized; R0025175:Table 3
A2	events	0 / 24	not stated; randomized; R0025175:Results

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-7 mmHg	2		26	not stated; randomized; R0025175:Table 2
26	A2	change	-3 mmHg	3		24	not stated; randomized; R0025175:Table 2

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	percent change	-4.8 percent	0.5		26	not stated; randomized; R0025175:Results
26	A2	percent change	1.0 percent	0.5		24	not stated; randomized; R0025175:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; randomized; R0025175:Results
	A2	events				0 / 24	not stated; randomized; R0025175:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; randomized; R0025175:Results
	A2	events				0 / 24	not stated; randomized; R0025175:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; randomized; R0025175:Results
	A2	events				0 / 24	not stated; randomized; R0025175:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 26	not stated; randomized; R0025175:Figure 1
	A2	events				0 / 24	not stated; randomized; R0025175:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 26	not stated; randomized; R0025175:Table 3
	A2	events				3 / 24	not stated; randomized; R0025175:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 26	not stated; randomized; R0025175:Table 3
	A2	events				1 / 24	not stated; randomized; R0025175:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 26	not stated; randomized; R0025175:Table 3
	A2	events				6 / 24	not stated; randomized; R0025175:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 26	not stated; randomized; R0025175:Table 3
	A2	events				2 / 24	not stated; randomized; R0025175:Table 3

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 24	not stated; randomized; R0025175:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; randomized; R0025175:Results
	A2	events				0 / 24	not stated; randomized; R0025175:Results