crossover randomized trial

EGOFIP

Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2

Design

Randomized: 24
Start year: 2013
Treatment: 10 weeks, follow-up 22 weeks
Countries: Denmark (1 sites)
Sponsor: Bispebjerg Hospital (non industry)
Eligibility: age 25 to 75; BMI above 25; HbA1c 42 to 86 mmol/mol; metformin or SU

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg	metformin or sulfonylurea or both; lifestyle: not reported	24	20	20
A2	Standard care or no added treatment No treatment (usual therapy)	metformin or sulfonylurea or both; lifestyle: not reported	24	20

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

Characteristic	Statistic	Liraglutide 1.2 mg subcutaneous once daily A1	Standard care or no added treatment A2	Whole trial ALL
age	mean (years)			57
age	sd (years)			9
bmi	mean (kg/m2)			33.1
bmi	sd (kg/m2)			4.4
diabetes duration	mean (years)			4
diabetes duration	sd (years)			3
egfr	mean (mL/min/1.73 m2)			88.2
egfr	sd (mL/min/1.73 m2)			4.8
hba1c	mean (mmol/mol)	52.1	49.8	52.8
hba1c	sd (mmol/mol)	7.2	9.3	8.2
lvef	mean (percent)			54.6
lvef	sd (percent)			5.8
metformin use	n			20
metformin use	percent			100
other dyslipidemia	n			19
other dyslipidemia	percent			95
other hypertension	n			16
other hypertension	percent			80
other male	n			15
other male	percent			75
other microalbuminuria	n			3
other microalbuminuria	percent			15
other sulfonylurea use	n			4
other sulfonylurea use	percent			20
sbp	mean (mmHg)	143	140
sbp	sd (mmHg)	14	12
waist	mean (cm)			115
waist	sd (cm)			10
weight	mean (kg)	100.9	100.6
weight	sd (kg)	10.8	10.1

25 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
10	A1	change	-9.2 mmol/mol	5.1		20	not stated; completers; R0018665:Table 3
10	A1	final	42.9 mmol/mol	4.0		20	not stated; completers; R0018665:Table 2
10	A1 vs A2	md	-10.1 mmol/mol		-13.9 to -6.4		not stated; completers; R0018665:Table 3
10	A2	change	0.9 mmol/mol	6.3		20	not stated; completers; R0018665:Table 3
10	A2	final	50.8 mmol/mol	8.9		20	not stated; completers; R0018665:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
10	A1	change	-2.0 kg	2.8		20	not stated; completers; R0018665:Table 3
10	A1	final	98.8 kg	11.7		20	not stated; completers; R0018665:Table 2
10	A1 vs A2	md	-1.9 kg		-3.6 to -0.2		not stated; completers; R0018665:Table 3
10	A2	change	-0.1 kg	2.5		20	not stated; completers; R0018665:Table 3
10	A2	final	100.5 kg	10.4		20	not stated; completers; R0018665:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0018665:Results
	A2	events				0 /	not stated; other; R0018665:Results

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
10	A1	change	-5 mmHg	9		20	not stated; completers; R0018665:Table 3
10	A1	final	137 mmHg	12		20	not stated; completers; R0018665:Table 2
10	A1 vs A2	md	-10 mmHg		-17 to -3		not stated; completers; R0018665:Table 3
10	A2	change	5 mmHg	12		20	not stated; completers; R0018665:Table 3
10	A2	final	144 mmHg	14		20	not stated; completers; R0018665:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 14	not stated; randomized; R0018665:Figure 3
A1	events	3 / 14	not stated; randomized; R0018665:Results
A2	events	0 / 10	not stated; randomized; R0018665:Figure 3
A2	events	0 / 10	not stated; randomized; R0018665:Results

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	3 / 14	not stated; randomized; R0018665:Figure 3
A1	events	3 / 14	not stated; randomized; R0018665:Results
A2	events	0 / 10	not stated; randomized; R0018665:Figure 3
A2	events	0 / 10	not stated; randomized; R0018665:Results