parallel randomized trial

MAGNA VICTORIA

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Design

Randomized: 50
Start year: 2013
Treatment: 26 weeks, follow-up 26 weeks
Countries: Netherlands (1 sites)
Sponsor: Leiden University Medical Center (industry)
Eligibility: age 18 to 69; BMI 25 or more; HbA1c 7.0 to 10.0 percent on metformin with or without sulfonylurea or insulin; no cardiovascular disease

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide	metformin with or without sulfonylurea or insulin; lifestyle: not reported	24	23	22
A2	Placebo Placebo	metformin with or without sulfonylurea or insulin; lifestyle: not reported	26	26	25

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	Placebo A2
age	mean (years)	60	59
age	sd (years)	6	7
bmi	mean (kg/m2)	32.6	31.6
bmi	sd (kg/m2)	4.4	3.4
diabetes duration	mean (years)	11	11
diabetes duration	sd (years)	6	7
established cvd: cerebrovascular or peripheral artery disease	n	2	0
established cvd: cerebrovascular or peripheral artery disease	percent	9	0
female	n	9	11
female	percent	39	42
hba1c	mean (percent)	8.4	8.2
hba1c	sd (percent)	1.1	1.0
insulin dose	mean (U/day)	70	69
insulin dose	sd (U/day)	46	58
insulin use	n	15	17
insulin use	percent	65	65
other sulfonylurea use	n	6	8
other sulfonylurea use	percent	26	31
sbp	mean (mmHg)	141	141
sbp	sd (mmHg)	14	15
uacr	mean (mmol/μg)	1.0	5.0
uacr	sd (mmol/μg)	1.3	8.9
waist	mean (cm)	111	109
waist	sd (cm)	10	9
weight	mean (kg)	98	94
weight	sd (kg)	14	13

16 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	-1.1 percent	1.0		23	not stated; modified itt; R0022308:Table 2
26	A1 vs A2	md	-0.3 percent		-0.8 to 0.2		not stated; modified itt; R0022308:Table 2
26	A2	change	-0.7 percent	0.9		26	not stated; modified itt; R0022308:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-4.3 kg	3.8		23	not stated; modified itt; R0022308:Table 2
26	A1 vs A2	md	-4.5 kg		-6.4 to -2.6		not stated; modified itt; R0022308:Table 2
26	A2	change	0.1 kg	2.5		26	not stated; modified itt; R0022308:Table 2

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0024672:Results
	A2	events				0 /	not stated; other; R0024672:Results

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0024672:Results
	A2	events				0 /	not stated; other; R0024672:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 23	not stated; modified itt; frequent hypoglycaemic events; R0022308:Results
A1	events	1 / 23	not stated; modified itt; repeated hypoglycaemic events; R0024672:Figure 1
A2	events	0 / 26	not stated; modified itt; R0024672:Figure 1
A2	events	0 / 26	not stated; modified itt; R0022308:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0024672:Results
	A2	events				0 /	not stated; other; R0024672:Results